A Self-Management Programme of Activity Coping and Education - SPACE for COPD(C) - in primary care: The protocol for a pragmatic trial

Introduction National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and efficacy for the intervention to be delivered and supported by HCPs and to examine whether group-based delivery of SPACE for COPD(C), with sustained support, improves patient outcomes following the SPACE for COPD(C) intervention. Methods and analysis A prospective, multi-site, single-blinded randomised controlled trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a six-session, group-based SPACE for COPD(C)self-management programme delivered over 5 months). The primary outcome is change in COPD assessment test at 6 months. A discussion session will be conducted with HCPs who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically. Ethics and dissemination The project has received a favourable opinion from South Hampshire B Research Ethics Committee, REC reference: 14/SC/1169 and full R&D approval from the University Hospitals of Leicester NHS Trust: 152408. Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, via the Collaboration and Leadership in Applied Health Research and Care and through social media. Trial registration ISRCTN17942821; pre-results.

National guidance for COPD suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education -SPACE for COPD©. SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE FOR COPD© intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and efficacy for the intervention to be delivered and supported by HCP's rather than researchers and experienced clinicians; and to examine whether group-based delivery of SPACE FOR COPD©, with sustained support, improves the maintenance of outcomes following the SPACE FOR COPD© intervention.

Methods and Analysis
A prospective, multi-site, single-blinded Randomised Controlled Trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a 6-session, groupbased SPACE for COPD© self-management programme delivered over 5 months).
The primary outcome is change in COPD Assessment Test at 6-months. • Much of the success depends on the willingness and ability of the participants to take part in, and travel to, group-based self-management support sessions in the community.
• In order to understand how the intervention could be delivered within existing health services and identify key barriers and facilitators to its implementation, the study will compare a variety of clinical and non-clinical, quantitative and qualitative outcomes between a group-based self-management support intervention and usual care.  (1). Symptoms and manifestations of the disease can be modified by adopting appropriate health behaviours, including but not limited to, exercise, physical activity, smoking cessation, anxiety management, breathing control, medication adherence and exacerbation management (2). Acknowledging the importance of the role of the patient in adopting these behaviours, there has been a shift in attitude from a traditional paternalistic model of care towards a more collaborative approach for chronic disease management. The NHS Five Year Forward View's aim is for the NHS to become better at helping people to manage their own health by staying healthy, making informed choices of treatment, managing conditions and avoiding complications (3). Inevitably, the patient is predominantly responsible for administering their own care, and making choices about health behaviours which will affect their outcomes. Self-management support aims to inform and support patients in making these choices. National and international guidelines for the management of COPD suggest that self-management support should be provided for people with COPD, though at present evidence for how and when that support should be delivered is less robust (2).  beyond the UK have been described in a stable population. Although the models of care delivered are quite heterogeneous (5), with some programmes providing up to two years of weekly supervised exercise training and education (3,(6)(7)(8). The infrastructure and resources required to provide such comprehensive support means they are unlikely to be deliverable to the breadth of the COPD population in the UK.
In order to address this, we previously developed and tested a new selfmanagement programme which offered a 'light touch' approach so that it could be provided on a larger scale.
A Self-management Programme of Activity Coping and Education -SPACE FOR COPD© -aims to support people with COPD in managing day-to-day tasks, minimise symptom burden, provoke health enhancing behaviour change and enhance emotional well-being. The programme is structured around the SPACE FOR COPD© manual, which combines both generic self-management skills and disease-specific tasks. Pilot testing assessed the feasibility and acceptability of the intervention to patients (9), and a fully powered randomised controlled trial assessed the efficacy of the intervention in primary care (10), powered for change in symptom burden measured by the self-reported Chronic Respiratory Questionnaire (CRQ-SR) dyspnoea domain at six months. In these studies the SPACE FOR COPD© manual was introduced to patients during an initial consultation with a healthcare professional (using motivational interviewing techniques), followed by two telephone calls during the subsequent six weeks. Secondary outcomes included other domains of the CRQ-SR, shuttle walking tests, disease knowledge, anxiety, depression, selfefficacy, smoking status and healthcare utilisation measured at baseline, six weeks and six months follow-up. Results demonstrated significant short-term improvements and learning through social observation (including social norms, social support or pressure, and the behaviours of others). Peer support and use of other patients as role models are approaches grounded in this theory, and directly applicable to groupbased self-management support interventions.
Delivery of SPACE for COPD© as a group-based intervention allows for several face-to-face contacts between patients and healthcare professionals over a number of sessions. These contacts could be spread out further across a longer period, which may be more successful in maintaining behaviour change. Furthermore, The SPACE for COPD© intervention has also previously been delivered by a member of the research team rather than by existing clinical services. If the groupbased intervention were to be implemented in primary care following the current study, importance would be placed on delivery by healthcare professionals in a format that is feasible and acceptable to healthcare professionals, health service providers and to patients. Understanding how this intervention can be delivered within existing health services and identifying key barriers and facilitators to its implementation is an important next step in the development of this complex intervention.
Objectives of the study 1. To examine whether group-based delivery of SPACE FOR COPD©, with sustained support, improves the maintenance of outcomes following the intervention.
2. To explore feasibility, acceptability and efficacy of the intervention to be delivered and supported by HCP's rather than researchers. 3. To explore HCP's experiences of delivering the intervention and identify any barriers to delivery in practice. 4. To understand, from the patient perspective, the feasibility and acceptability of the SPACE for COPD© intervention delivered by HCPs in a group-based, community setting. The trial is a prospective, multi-site, single (assessor) blinded randomised controlled trial comparing a community based, HCP led, group-based self-management programme based on the SPACE for COPD© manual with usual care. The design of the study and flow of participants is described in figure 1. The study will be run across Leicestershire and Rutland, and a total of 150 participants will be recruited (75 in the intervention group and 75 in the control group).

Recruitment of participants
We will recruit participants with COPD, who will be identified from primary care (GP) COPD registers and from patients who respond to a poster advertisement that will be displayed at GP practices and hospitals. We will also recruit participants from the following areas within the Respiratory Biomedical Research Unit at University Hospitals of Leicester: • Those who have been involved in previous research trials who have agreed to be contacted again; or • Those who were unsuitable for previous research trials, but who agreed to be contacted about future research trials for which they might be eligible.

Participant invitation
Eligible individuals identified as having an established diagnosis of COPD are sent an invitation letter, a patient information sheet about the study, and a reply slip. For those recruited directly from primary care, the invitation letters are sent by the primary care practice where the search was conducted. For those recruited from Individuals who are interested in taking part are asked to return a reply slip directly to the SPACE for COPD© research team. Interested participants are then contacted via their preferred contact method and an appointment is arranged for a baseline visit.

Eligibility criteria
Participants are eligible for the trial if they have: Patients are excluded from participating in the trial if they are: • Unable to participate in the exercise component of the SPACE for COPD© programme due to neurological, locomotive, or psychiatric disability; or other comorbidities.
• Unable to read/write English to the level of an eight year old • Unwilling to be randomised • Previous participants of Pulmonary Rehabilitation or have received the SPACE for COPD© manual in the previous 12 months.

Randomisation
Once participants have consented to take part in the study and spirometry has confirmed a COPD diagnosis, participants are randomised by an un-blinded member of the study team using an online randomisation tool (sealed envelope;(14).
Individuals are randomised (1:1) to the control group or the intervention (SPACE 11 FOR COPD© group-based self-management programme) group. The system randomises patients in random permuted blocks. This allows for the 1:1 ratio, but due to the random permuted blocks of 2, 4, or 6 ensures full randomisation. Simple randomisation has been chosen as there has been no requirement to stratify by age, gender, location, or other variables. Participants are immediately informed of their allocated treatment by an un-blinded member of the study team. Un-blinding is permissible in the case of medical emergencies (e.g., cardiac arrest) or patients being admitted to hospital for an exacerbation.

Study Interventions
Usual Care (Control Group) Participants in the control group will continue with any usual check-ups/reviews and there will be no additional care provided or removed from their current access. If patients are referred to pulmonary rehabilitation in the duration of their time in the study, they will not be denied access to the programme; however, they will not be included in the final analysis due to the use of 'intention-to-treat' analysis. No additional advice, information or recommendations will be provided to participants in this group.

SPACE for COPD© group-based self-management programme
Participants in the intervention group receive a SPACE for COPD© manual and asked to attend the SPACE for COPD© group-based self-management programme usually within one month of their baseline appointment. The aim of the SPACE for COPD© programme is to support people with COPD in managing day-to-day tasks, minimise symptom burden, provoke health enhancing behaviour change and enhance emotional well-being. The programme is structured around the SPACE FOR COPD© manual, which combines both generic self-management skills and disease-specific tasks. The programme is facilitated by two trained healthcare professionals (e.g., physiotherapists, respiratory specialist nurses, occupational therapists, health psychologists) to groups of up 10 participants, and delivered through six, two hour sessions, over a five month period. These sessions will be held at community venues, at times and locations to suit participants of the group to increase retention. Participants are liaised with in regards to preferences on timings and location of the group sessions to increase retention, and engagement in the intervention. The content of the programme and accompanying self-management components (15), are presented in Tables 1 and 2. Participants will also be asked to complete the exercise component of the manual at home in their own time. A full description of the rationale, development and efficacy of the work underpinning the SPACE for COPD© manual is detailed elsewhere (9).   1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59

A6. Practical support with adherence (medication or behavioural)
Walking and strength training diaries are provided for participants and discussed during sessions.
Walking and strength training diaries are provided for participants and discussed during solution focused goal feedback at the beginning of sessions 3-6 (sessions 3-6).

A8. Safety netting
Participants are able to call programme facilitators between sessions if needed Participants are provided with contact details for programme facilitators who they can call if needed (this is a constant throughout the programme).

A11. Training/rehearsal for practical self-management activities
Including: • managing shortness of breath • saving your energy Session 2: Managing shortness of breath (session 2 only). Session 3: Saving your energy (session 3 only).

A12. Training/rehearsal in psychological strategies
Including: • goal setting (including action planning) • solution focussed goal feedback • problem solving • self-reward and social reward • managing stress and emotions Goal setting activity (including action planning) and solution focussed goal feedback (once every week).

Intervention fidelity
Intervention facilitators are registered health professionals (physiotherapists, respiratory nurse specialists, health psychologists). In total, 8 registered health professionals were trained to deliver the SPACE for COPD© group-based intervention by two Health Psychologists.
All facilitators attended a one day training course to ensure that they understood the theories and philosophy underpinning the SPACE for COPD© group-based programme and the content and resources used within it. All facilitators were given a facilitator manual to support their delivery of the programme and given the opportunity to practise delivering at least one activity from the manual during the training session.

Quality Assurance
Quality assurance will be undertaken to assess delivery of intervention content and educational style. Intervention fidelity checklists for intervention facilitators and trained observers have been specifically designed for the study. Intervention facilitators will complete checklists at the end of each self-management group session, and one of the trainers will observe one session per self-management group, completing their own checklist. Intervention facilitators will receive written and verbal feedback from the trained assessor.

Physical Activity
Physical activity is assessed using physical activity monitors. The 'Bodymedia Sensewear' (APC Cardiovascular, UK) activity monitor is a biaxial accelerometer that can report a number of parameters including step count and energy expenditure. We will also use this data to assess compliance to the physical activity recommendation  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   21   of undertaking at least 150 minutes of moderate intensity physical activity per week   in bouts of at least 10 minutes. Participants are asked to wear the activity monitor on   the back of their right arm for seven consecutive days (24 hours a day if possible) following their baseline, 6-month and 9-month visits.

Health related quality of life
Health related quality of life data will be measured using the European Quality of Life-5 Dimensions (EQ-5D;(20,21)). The EQ-5D is a standardized questionnaire that was developed for use as a measure of health outcomes and defines health in terms of five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

Chronic Respiratory Questionnaire (CRQ-SR)
Disease specific health related quality of life (HRQoL) will be measured by the selfadministered standardised CRQ-SR (22). An individual change of at least 0.5/domain (dyspnoea, fatigue, emotional functioning, mastery) is considered clinically important (23). There is both an initial and follow-up version depending on time of administration.

Anxiety and Depression
Depression and anxiety will be measured using the Hospital Anxiety and Depression (HADS) Scale, to produce independent subscales for anxiety and depression (24).  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   22   The HADS is a self-report rating scale of 14 items on a four-point Likert scale range   (0-3). The HADS is a validated and a widely used questionnaire for screening for the separate dimensions of anxiety and depression and possible occurrence of anxiety and depression from patients (25) and the general population (26). It measures anxiety and depression (seven items for each subscale). Cronbach's coefficient was 0.884, which indicates good reliability. Published cut-off scores for clinically relevant indications of depression and anxiety recommend a score of 8 for each subscale (27).

Patient Activation
Patient activation (participants' knowledge, skill, and confidence for managing their own health and health care) will be measured using the Patient Activation Measure (PAM; (28). This is a 13-item patient-reported measure that has been validated in the United Kingdom as powerful and reliable measure of patient activation. Participants indicate their level of agreement on a four-point scale (strongly disagree to strongly agree) and responses are added to yield a raw score between 13 and 52. The raw score is calibrated to an activation score between 0 and 100 (the higher the score the higher the level of activation), which is then used to classify participants into one of four levels of activation (level 1: low activation; level 4: high activation).

COPD Knowledge
The Bristol COPD Knowledge Questionnaire (BCKQ) will be utilised to understand patients' informational requirements and understanding and their knowledge base of COPD (29). The questionnaire is comprehensive and goes into detail, regarding

Qualitative Data Collection
Those participants allocated to the intervention group are invited to take part in qualitative semi-structured focus groups at the end of the SPACE for COPD intervention. The aim of the focus groups will be to understand participants' experiences of the group-based self-management programme. More specifically, the data we collect will inform: • Acceptability and usefulness of the programme to participants in this format and over this time period; • The content of the intervention; • Approaches to recruitment.
Up to 10 focus groups will be conducted with between 4-10 participants (number dependent on each intervention group size). Purposive sampling will be employed to recruit intervention participants. Audio-recorded focus group discussions (approximately 60 minutes) will be conducted face-to-face between each participant group, an experienced interviewer and an observer/note-taker. Focus groups will be transcribed verbatim by a professional transcriber, with identifiable information removed. Focus group questions have been devised based upon relevant literature and experience of the team.
Healthcare professionals delivering the SPACE for COPD© self-management support intervention will be invited to participate in a meeting to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice and derive practical recommendations for doing so. All staff involved in delivering the intervention will be approached to participate in a 2 hour discussion and will be given an information sheet and at least 48 hours to consider their involvement prior to consent. Minutes will be taken during the discussion and anonymised.

Study Power
The power calculation was based on the primary outcome at 6-months (30, 31). To detect a mean ±SD between-group difference of 2.5±5.0 in the change in CAT with 80% power, 60 people per group are required (α=0.05, two-tailed). In anticipation of a possible 25% attrition rate, the total sample size was increased to 75 per group (150 in total).

Quantitative Analysis
This will primarily be completed on an intention-to-treat analysis. All quantitative data will be assessed for normality and analysed using appropriate parametric and nonparametric statistics, statistical significance will be set at p=0.05. Secondary per protocol analyses will be carried out. A post hoc analysis will be carried out, which will exclude patients in either arm that received pulmonary rehabilitation as part of their usual care. We would anticipate that patients who participate within the study, will not require Pulmonary Rehabilitation. However, due to Pulmonary Rehabilitation being a part of 'best' usual care, this will not be withheld from the patient.
Quantitative data for all outcomes will be transcribed from the CRF onto an electronic database. A statistical software package will be used to carry out quantitative analyses. Predictive Analaytics Software (SPSS) will be used to analyse the data, the license for which is provided by University Hospitals of Leicester NHS Trust. Continuous variables will be presented as mean and standard deviation (SD) or median and inter quartile range (IQR), and categorical data will be presented as frequencies and percentages. Data will be checked for normality and appropriate parametric and nonparametric tests will be used. Any baseline differences will be adjusted for. Any missing data will be imputed, and both intention-to-treat and per protocol analyses will be conducted.
We have not secured funding for a healthcare utilisation analysis but would anticipate further CLAHRC (Collaboration and Leadership in Applied Health Research and Care) funding if the trial is clinically effective.

Qualitative Analysis
The focus groups will be analysed using Thematic Analysis (32) supported by Nvivo software (version 9). This approach follows six distinct stages: familiarization with naming themes and producing the report. The psychologist and the physiotherapist will carry out initial coding and a sample of interviews will be coded by another member of the team to ensure consistency and to enhance interpretive authenticity.
Throughout the data analysis, the team will meet to discuss and review emerging themes and search for accounts that provide contesting views of the same phenomena or identify different phenomena. Our patient representatives will be invited to comment on our (anonymised) initial findings to ensure interpretations made by researchers stay close to the direct experience of patients (33).
All patient information that is collected during the course of the research will be kept strictly confidential. Any information about the patient which leaves the hospital will have their name and address removed. Participants will not be identified in any subsequent written material. Results will be reported in such a way that completely preserves confidentiality.

Ethics
The trial is sponsored by the University Hospitals of Leicester NHS Trust (study number 152408) and ethical approval was granted by the Hampshire B Research Ethics Committee (REC reference: 14/SC/11/69). Protocol amendments will be approved by the ethics committee and regulatory authorities as per current guidelines and will be communicated to relevant parties by the study team.

Dissemination
We plan to publish the results of the study in peer-reviewed journals and present them at appropriate national and international respiratory and physiotherapy conferences. Social media will be utilised to disseminate information and summaries of results to a wider population.
The CLAHRC East Midlands, is a large organisation which strives to improve health outcomes in the population across the East Midlands through delivering high quality, world class research. This organisation will be used to further disseminate results within the East Midlands. We also hope to provide a summary of results to the study participants. We also plan to hold a participant dissemination day towards the end of the study. This will enable participants to contribute to the final report and other result dissemination activities.
The institution also has an active and dynamic Public Involvement group for pulmonary and cardiovascular rehabilitation. The group will be used to create and co-ordinate strategies for further disseminating the results into the public domain.

Methods: Participants, interventions, and outcomes
Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained 9 Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) 10 Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be administered 11-16 11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease) Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests) 17 11d Relevant concomitant care and interventions that are permitted or prohibited during the trial 11 Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended

18-24
Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) 19 & diagram 1

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions 10-11 Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned 10 Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions 10-11 Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial 11

Data collection methods 18a
Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol

18-24 18b
Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols N/A Methods for any additional analyses (eg, subgroup and adjusted analyses) 25 20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) 25

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial N/A We have developed a self-management manual for patients with Chronic Obstructive Pulmonary Disease (COPD). This has been done with enormous help from patients like yourself. The manual covers issues such as drug and symptom management, exercise and nutrition at home.
In a previous study, we provided this manual for people to work through at home, with one initial meeting with a healthcare professional. While that study showed there were several benefits to having the manual, we would now like to see if the benefits will last longer if support from the healthcare professional is increased. Also patients have told us they would like the manual to be and supported in a peer group environment. This study, therefore, will test the effectiveness of using the manual within a group setting over a number of sessions.
We would like to know how effective the use of this manual may be when delivered and supported in a group environment. This will help us improve future patient care.

Why have I been invited?
As an individual with COPD you have been identified as a suitable participant by your GP or your healthcare professional. You might have also been involved in a previous research trial and agreed to be contacted again or agreed to be contacted about future trials for which you might be eligible. It is important we see how people progress using the manual we have developed compared to those who receive standard care from their GP or healthcare professional. This knowledge may help us develop and improve future services.

Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. Your decision to withdraw will not influence any medical care you receive.

If you agree to part what will happen?
Once you have provisionally agreed to take part in the research you will be contacted to arrange a date and time to discuss the project in more detail. You will be invited to attend an appointment which will take place at Glenfield Hospital. If you still wish to go ahead at this stage then we will ask you to sign a consent form to take part in the study. Following this we will do some lung function tests. These are tests where you blow out into a tube as hard as you can. This confirms that you do have a diagnosis of COPD. You will then be randomly allocated to one of two arms of the trial. Half of the people in the study will be randomly allocated to receive the self-management group programme. The other half will be randomly assigned to 'usual care' which means that we will not change any of your current treatment or care. You will be randomly allocated to one of these two arms of the study by a computerbased system. This means that we will not know before hand which arm of the study you will be in. It is important that this is done at random in order to keep the results of the study fair.

What do I have to do?
If you are assigned to the usual care group you will continue as normal with the treatment you receive from your GP and healthcare team. At your first visit with us, you will be requested to complete some questionnaires about your health status. These will take about 20 minutes to complete. We will also ask you to wear an activity monitor for the following 7 days at home. The monitor is a small device which is worn around your arm, and it measures your activity levels at home. We will arrange to collect this from you after you have finished wearing it. We will ask you to repeat the questionnaires and wearing of the activity monitor after 6 months, and then again 3 months later (9 months from starting the study and your final assessment). In addition to the questionnaires and activity monitor at 6 months and 9 months, we will ask you to attend the hospital to do some walking tests. These will be done at Glenfield Hospital. There will usually be three walking tests, which are done on a flat corridor, walking up and down a 10 metre course. It is usual to become breathless during these tests, however we will only ask you to do as much as you feel you can.
If you are assigned to the self-management group you will undergo the same assessments at the same time points as the usual care group. However, in addition to these we will also ask you to do the walking tests at all three time points (i.e. your first visit, 6 month visit and 9 month visit). These will all take place at Glenfield Hospital. In between your first visit and your 6 month visit we will ask you to attend the group sessions to introduce you to the selfmanagement programme. These will take place at a community centre. There will be approximately between six and 10 people in each group, and all sessions will be led by 2 healthcare professionals. Each session will last approximately two hours. At your first session you will be given the SPACE FOR COPD manual, and each session thereafter will discuss a different topic about how to manage with COPD. You will be advised how you can increase your activities at home, improve management of your breathlessness and learn what to do if you develop a chest infection. You do not have to discuss anything within the group if you do not wish to, and everything discussed within the group will be kept confidential. At the end of the self-management programme we will also ask you to take part in a focus group discussion where you will have an opportunity to discuss your experiences of the programme and whether you thought it was useful to you. The focus group will last During the study, and immediately afterwards the study team will access your medical notes to obtain long term follow up data (for example GP visits, hospital admissions).
6. Are there any risks, disadvantages or side-effects of taking part?
We do not expect there are any risks to taking part in this study.
One potential disadvantage to taking part is the time you give to the study. Your first visit may take up to two hours. Your six-month and nine-month visits may take up to one hour each.
Whilst completing the walking tests, you may become short of breath, however we expect this will recover once you sit and rest. Afterwards, you may experience some achiness in your muscles and feel tired. This is usually only lasts a day or two.

What are the possible benefits of taking part?
We hope that the research will aid you in your understanding of COPD and how you can improve your symptoms. Information gathered will inform both present and future research, aiming to provide better care for people living with COPD.

What if something goes wrong?
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms would be available to you.
Should you wish to discuss any concerns about this study further, the Patient Information and Liaison Service is a point of contact for you. Their telephone number is 0808 178 8337.

Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you, which leaves the medical centre, will have your name and address removed so that you cannot be recognised from it. Some of your anonymised data will be shared with Insignia Health (a healthcare organisation) and entered onto a secure database to help improve patient outcome measures. This will be basic information, for example age, gender and some questionnaire data. Participants will not be identified in any subsequent written material. Results will be reported in such a way that completely preserves confidentiality. Data will be stored at Glenfield Hospital, and on University Hospitals of Leicester secure networks. We will, with your consent inform your GP of your participation in the trial and share with your GP any relevant test results that have been made during your participation in the trial.

1What will happen to the results of the research study?
The results of the study will be written in peer and lay journals, professional publications and presentations made at relevant conferences. Results will be reported in such a way that preserves confidentiality. All participants will also receive a summary of the results.

Who is organising and funding the research?
This study is being organised by staff employed at University Hospitals of Leicester NHS trust. It is being funded by a Collaboration and Leadership in Applied Health Research and Care East Midlands (CLAHRC).

Who has reviewed the study?
All research that involves the NHS is reviewed by an NHS Research Ethics Committee. This study has been reviewed and given a favourable opinion by Hampshire B research Ethics Committee. This does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information of which to make an informed decision. The study has also been reviewed and is sponsored by University Hospitals of Leicester. 6. I understand that some of my data will be shared with Insignia Health and entered onto a secure database to help improve patient outcome measures, if it is anonymised.

Contact for further information
7. I agree to take part in the above study.
8. I understand that all discussions at group sessions are confidential and I agree to respect this confidentiality.

Methods and Analysis
A prospective, multi-site, single-blinded Randomised Controlled Trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a 6-session, groupbased SPACE for COPD© self-management programme delivered over 5 months).
The primary outcome is change in COPD Assessment Test at 6-months.
A discussion session will be conducted with HCP's who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the 3 intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically.

Ethics and Dissemination
The project has received a favourable opinion from South Hampshire B Research

Strengths and Limitations:
• The burden of COPD is significant to both the health service and the individual. Supported Self-management is important but options are limited for those with COPD. This study explores a group based supported selfmanagement programme for individuals with COPD. • This is a pragmatic trial where the study intervention (a group-based selfmanagement support intervention for people with COPD) will be delivered and supported by healthcare professionals in community settings. The study has been designed to align with how the intervention might be delivered in routine clinical practice.
• Our follow-up period is 3 months post intervention. Unfortunately, due to funding constraints we are unable to carry out a longer-term follow-up.'  (3). Inevitably, the patient is predominantly responsible for administering their own care, and making choices about health behaviours which will affect their outcomes. Self-management support aims to inform and support patients in making these choices. National and international guidelines for the management of COPD suggest that self-management support should be provided for people with COPD, though at present evidence for how and when that support should be delivered is less robust (2).
Reports in the literature describe programmes that have targeted interventions for patients who have been hospitalised with a COPD-related admission, often with the primary ambition of reducing future admissions (4). These studies have had little impact on readmission. Arguably, the offer of supported self-management should be offered earlier in the disease trajectory. Other COPD self-management programmes  (5), with some programmes providing up to two years of weekly supervised exercise training and education (3, 6-8). The infrastructure and resources required to provide such comprehensive support means they are unlikely to be deliverable to the breadth of the COPD population in the UK.
In order to address this, we previously developed and tested a new selfmanagement programme which offered a 'light touch' approach so that it could be provided on a larger scale.   Delivery of SPACE for COPD© as a group-based intervention allows for several face-to-face contacts between patients and healthcare professionals over a number of sessions. These contacts could be spread out further across a longer period, which may be more successful in maintaining behaviour change. Furthermore, The SPACE for COPD© intervention has also previously been delivered by a member of the research team rather than by existing clinical services. If the groupbased intervention were to be implemented in primary care following the current study, importance would be placed on delivery by healthcare professionals in a format that is feasible and acceptable to healthcare professionals, health service providers and to patients. Understanding how this intervention can be delivered within existing health services and identifying key barriers and facilitators to its implementation is an important next step in the development of this complex intervention.
Aims and objectives of the study 1. To examine whether group-based delivery of SPACE FOR COPD©, with sustained support, improves patient outcomes following the intervention compared to a control group.
2. To explore feasibility, acceptability and efficacy of the intervention to be delivered and supported by HCP's. This will be done by: a. Exploring HCP's experiences of delivering the intervention and identify any barriers to delivery in practice.
b. Understanding, from the patient perspective, the feasibility and acceptability of the SPACE for COPD© intervention delivered by HCPs in a group-based, community setting.

Study design
The trial is a prospective, multi-site, single (assessor) blinded randomised controlled trial comparing a community based, HCP led, group-based self-management programme based on the SPACE for COPD© manual with usual care. The design of the study and flow of participants is described in figure 1. The study will be run across Leicestershire and Rutland, and a total of 150 participants will be recruited (75 in the intervention group and 75 in the control group).

Recruitment of participants
We will recruit participants with COPD, who will be identified from primary care (GP) COPD registers and from patients who respond to a poster advertisement that will be displayed at GP practices and hospitals. We will also recruit participants from the following areas within the Respiratory Biomedical Research Unit at University Hospitals of Leicester: • Those who have been involved in previous research trials who have agreed to be contacted again; or • Those who were unsuitable for previous research trials, but who agreed to be contacted about future research trials for which they might be eligible.

Participant invitation
Eligible individuals identified as having an established diagnosis of COPD are sent an invitation letter, a patient information sheet about the study, and a reply slip. For those recruited directly from primary care, the invitation letters are sent by the primary care practice where the search was conducted. For those recruited from

Randomisation
Once participants have consented to take part in the study and spirometry has confirmed a COPD diagnosis, participants are randomised by an un-blinded member

Study Interventions
Usual Care (Control Group) Participants in the control group will continue with any usual check-ups/reviews and there will be no additional care provided or removed from their current access. If patients are referred to pulmonary rehabilitation in the duration of their time in the study, they will not be denied access to the programme; however, they will not be included in the final analysis due to the use of 'intention-to-treat' analysis. No additional advice, information or recommendations will be provided to participants in this group.  Participants will also be asked to complete the exercise component of the manual at home in their own time. A full description of the rationale, development and efficacy of the work underpinning the SPACE for COPD© manual is detailed elsewhere (9).
The intervention will be offered over a period of 2 years (the duration of the active

A6. Practical support with adherence (medication or behavioural)
Walking and strength training diaries are provided for participants and discussed during sessions.
Walking and strength training diaries are provided for participants and discussed during solution focused goal feedback at the beginning of sessions 3-6 (sessions 3-6).

A8. Safety netting
Participants are able to call programme facilitators between sessions if needed Participants are provided with contact details for programme facilitators who they can call if needed (this is a constant throughout the programme).

A11. Training/rehearsal for practical self-management activities
Including: • managing shortness of breath • saving your energy

A12. Training/rehearsal in psychological strategies
Including: • goal setting (including action planning) • solution focussed goal feedback • problem solving • self-reward and social reward • managing stress and emotions Goal setting activity (including action planning) and solution focussed goal feedback (once every week).
Problem solving (this is a constant throughout the programme).

A13. Social support
Including: • practical support • emotional support Participants are encouraged to share experiences, advice, ideas and support each other (this is a constant throughout the programme).

Intervention fidelity
Intervention facilitators are registered health professionals (physiotherapists, respiratory nurse specialists, health psychologists). In total, 8 registered health professionals will be trained to deliver the SPACE for COPD© group-based intervention by two Health Psychologists.
All facilitators attended a one day training course to ensure that they understood the theories and philosophy underpinning the SPACE for COPD© group-based programme and the content and resources used within it. All facilitators were given a facilitator manual to support their delivery of the programme and given the opportunity to practise delivering at least one activity from the manual during the training session.

Physical Activity
Physical activity is assessed using physical activity monitors. The 'Bodymedia Sensewear' (APC Cardiovascular, UK) activity monitor is a biaxial accelerometer that  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   22 can report a number of parameters including step count and energy expenditure. We will also use this data to assess compliance to the physical activity recommendation of undertaking at least 150 minutes of moderate intensity physical activity per week in bouts of at least 10 minutes. Participants are asked to wear the activity monitor on the back of their right arm for seven consecutive days (24 hours a day if possible) following their baseline, 6-month and 9-month visits.

Health related quality of life
Health related quality of life data will be measured using the European Quality of Life-5 Dimensions (EQ-5D;(20,21)). The EQ-5D is a standardized questionnaire that was developed for use as a measure of health outcomes and defines health in terms of five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

Anxiety and Depression
Depression and anxiety will be measured using the Hospital Anxiety and Depression (HADS) Scale, to produce independent subscales for anxiety and depression (24).
The HADS is a self-report rating scale of 14 items on a four-point Likert scale range

Patient Activation
Patient activation (participants' knowledge, skill, and confidence for managing their own health and health care) will be measured using the Patient Activation Measure (PAM; (28). This is a 13-item patient-reported measure that has been validated in the United Kingdom as powerful and reliable measure of patient activation. Participants indicate their level of agreement on a four-point scale (strongly disagree to strongly agree) and responses are added to yield a raw score between 13 and 52. The raw score is calibrated to an activation score between 0 and 100 (the higher the score the higher the level of activation), which is then used to classify participants into one of four levels of activation (level 1: low activation; level 4: high activation).  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y 24

COPD Knowledge
The Bristol COPD Knowledge Questionnaire (BCKQ) will be utilised to understand patients' informational requirements and understanding and their knowledge base of COPD (29). The questionnaire is comprehensive and goes into detail, regarding various aspects of COPD, for example epidemiology, signs and symptoms, and exacerbations and treatment.

Outcomes to assess feasibility and acceptability of trial parameters
We will use the following outcomes to assess the feasibility and acceptability of trial parameters:

Screening
Defined as the number of packs sent out to patients from GP practices and assessed for eligibility using inclusion/exclusion criteria by a study researcher.

Eligibility
Calculated by dividing number of people screened for eligibility by those who meet the inclusion criteria.

Group characteristics
Group characteristics (e.g., age, gender, GOLD stage, MRC, exercise capacity, physical activity) will be compared between completers and non-completers.

Retention
Defined as the number of participants who remain in the study and do not drop-out.

Study Completion
Defined by the number of participants who complete the COPD Assessment Test.
Completion rates will be calculated at baseline, 6-month and 9-month follow-up.
Intervention adherence and completion rates This will be measured by summing the total number of self-management programme sessions attended by participants allocated to the intervention group. We will also look at the average group size across each of the six self-management programme sessions and compare with the number of participants allocated to each of the selfmanagement programme groups.

Qualitative Data Collection
Those participants allocated to the intervention group are invited to take part in qualitative focus groups at the end of the SPACE for COPD© intervention. Focus groups have been chosen due to their generation of information on collective views, and the meanings that lie behind those views. The aim of the focus groups will be to understand participants' experiences of the group-based self-management programme. More specifically, the data we collect will inform:  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   26 • Acceptability and usefulness of the programme to participants in this format and over this time period; • The content of the intervention; • Approaches to recruitment.
Focus groups will be conducted with each self-management programme group, with between 3 and 10 participants (number dependent on each group size). This difference in participant numbers allows for participant opinions to be gathered even if a small group is encountered (e.g., due to drop-out). Although three is a very small number for a focus group, it allows all participant opinions to be gathered, regardless of group size. Participants will be familiar with one another (which can help facilitate discussion or the ability to challenge each other comfortably) as they have attended multiple group sessions together. Purposive sampling will be employed to recruit intervention participants. Audio-recorded focus group discussions (approximately 60 minutes) will be conducted face-to-face between each participant group, an experienced interviewer and an observer/note-taker. Focus groups will be carried out at the end of the last group session for participant ease, as discussed with study patient representatives. We will prompt participants allocated to each selfmanagement group of the focus group discussion prior to the last session in the attempt to gain experiences from as many participants as possible, regardless of the number of sessions attended in total. Focus groups will be transcribed verbatim by a professional transcriber, with identifiable information removed. Focus group questions have been devised based upon relevant literature and experience of the team. Healthcare professionals delivering the SPACE for COPD© self-management support intervention will be invited to participate in a meeting to discuss aspects of feasibility and acceptability, such as gaining insight into any potential facilitators/barriers to implementing the intervention in practice (and derive practical recommendations for doing so). Minutes will be taken during the discussion and anonymised.

Study Power
The power calculation was based on the primary outcome at 6-months (30, 31). To detect a mean ±SD between-group difference of 2.5±5.0 in the change in CAT with 80% power, 60 people per group are required (α=0.05, two-tailed). In anticipation of a possible 25% attrition rate, the total sample size was increased to 75 per group (150 in total).

Quantitative Analysis
This will primarily be completed on an intention-to-treat analysis. All quantitative data will be assessed for normality and analysed using appropriate parametric and nonparametric statistics (e.g., within and between measures t-tests and ANOVAs), statistical significance will be set at p=0.05. Secondary per protocol analyses will be carried out. A post hoc analysis will be carried out, which will exclude patients in either arm that received pulmonary rehabilitation as part of their usual care. We would anticipate that patients who participate within the study, will not require Pulmonary Rehabilitation. However, due to Pulmonary Rehabilitation being a part of 'best' usual care, this will not be withheld from the patient.
Quantitative data for all outcomes will be transcribed from the CRF onto an electronic database. A statistical software package will be used to carry out quantitative analyses. Predictive Analaytics Software (SPSS) will be used to analyse the data, the license for which is provided by University Hospitals of Leicester NHS Trust. Continuous variables will be presented as mean and standard deviation (SD) or median and inter quartile range (IQR), and categorical data will be presented as frequencies and percentages. Data will be checked for normality and appropriate parametric and nonparametric tests will be used. Any baseline differences will be adjusted for. Any missing data will be imputed, and both intention-to-treat and per protocol analyses will be conducted.
We have not secured funding for a healthcare utilisation analysis but would anticipate further CLAHRC (Collaboration and Leadership in Applied Health Research and Care) funding if the trial is clinically effective. The focus groups will be analysed using Thematic Analysis (32) supported by Nvivo software (version 9). This approach follows six distinct stages: familiarization with data; generating initial codes; searching for themes; reviewing themes; defining and naming themes and producing the report. The psychologist and the physiotherapist will carry out initial coding and a sample of interviews will be coded by another member of the team to ensure consistency and to enhance interpretive authenticity.
Throughout the data analysis, the team will meet to discuss and review emerging themes and search for accounts that provide contesting views of the same phenomena or identify different phenomena. Our patient representatives will be invited to comment on our (anonymised) findings throughout the analysis process to ensure interpretations made by researchers stay close to the direct experience of patients (33).
All patient information that is collected during the course of the research will be kept strictly confidential. Any information about the patient which leaves the hospital will have their name and address removed. Participants will not be identified in any subsequent written material. Results will be reported in such a way that completely preserves confidentiality. Ethics Committee (REC reference: 14/SC/11/69). Protocol amendments will be approved by the ethics committee and regulatory authorities as per current guidelines and will be communicated to relevant parties by the study team.

Dissemination
We plan to publish the results of the study in peer-reviewed journals and present them at appropriate national and international respiratory and physiotherapy conferences. Social media will be utilised to disseminate information and summaries of results to a wider population.
The CLAHRC East Midlands, is a large organisation which strives to improve health outcomes in the population across the East Midlands through delivering high quality, world class research. This organisation will be used to further disseminate results within the East Midlands. We also hope to provide a summary of results to the study participants. We also plan to hold a participant dissemination day towards the end of the study. This will enable participants to contribute to the final report and other result dissemination activities.
The institution also has an active and dynamic Public Involvement group for pulmonary and cardiovascular rehabilitation. The group will be used to create and co-ordinate strategies for further disseminating the results into the public domain. The study may also be subject to internal and further external audits to ensure safety of the trial.

CONCLUSION
The importance of self-management is widely acknowledged and opportunities should be maximised from the time of diagnosis through to more severe disease.
Opportunities to improve self-management skills should be embedded in a pulmonary rehabilitation programme. In the future, there may be an opportunity to explore the value of the SPACE for COPD© programme alongside rehabilitation, or indeed, an alternative for those unwilling or unable to attend. However, for those with milder disease there is no provision for a structured supported self-management programme in the UK. Evidence suggests that the SPACE for COPD© package is effective when delivered on an individual basis (10). This study examines its effectiveness as a group-based intervention in the community, as an alternative supported self-management strategy, which importantly allows patient choice.
7. I agree to take part in the above study.
8. I understand that all discussions at group sessions are confidential and I agree to respect this confidentiality.
9. I agree to take part in a focus group discussion at the end of the self-management programme which will be recorded and transcribed for research purposes. I also agree that anonymised direct quotes can be used for research purposes.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  We have developed a self-management manual for patients with Chronic Obstructive Pulmonary Disease (COPD). This has been done with enormous help from patients like yourself. The manual covers issues such as drug and symptom management, exercise and nutrition at home.
In a previous study, we provided this manual for people to work through at home, with one initial meeting with a healthcare professional. While that study showed there were several benefits to having the manual, we would now like to see if the benefits will last longer if support from the healthcare professional is increased. Also patients have told us they would like the manual to be and supported in a peer group environment. This study, therefore, will test the effectiveness of using the manual within a group setting over a number of sessions.
We would like to know how effective the use of this manual may be when delivered and supported in a group environment. This will help us improve future patient care.

Why have I been invited?
As an individual with COPD you have been identified as a suitable participant by your GP or your healthcare professional. You might have also been involved in a previous research trial and agreed to be contacted again or agreed to be contacted about future trials for which you might be eligible. It is important we see how people progress using the manual we have developed compared to those who receive standard care from their GP or healthcare professional. This knowledge may help us develop and improve future services.

Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  take part you are still free to withdraw at any time and without giving a reason. Your decision to withdraw will not influence any medical care you receive.

If you agree to part what will happen?
Once you have provisionally agreed to take part in the research you will be contacted to arrange a date and time to discuss the project in more detail. You will be invited to attend an appointment which will take place at Glenfield Hospital. If you still wish to go ahead at this stage then we will ask you to sign a consent form to take part in the study. Following this we will do some lung function tests. These are tests where you blow out into a tube as hard as you can. This confirms that you do have a diagnosis of COPD. You will then be randomly allocated to one of two arms of the trial. Half of the people in the study will be randomly allocated to receive the self-management group programme. The other half will be randomly assigned to 'usual care' which means that we will not change any of your current treatment or care. You will be randomly allocated to one of these two arms of the study by a computerbased system. This means that we will not know before hand which arm of the study you will be in. It is important that this is done at random in order to keep the results of the study fair.

What do I have to do?
If you are assigned to the usual care group you will continue as normal with the treatment you receive from your GP and healthcare team. At your first visit with us, you will be requested to complete some questionnaires about your health status. These will take about 20 minutes to complete. We will also ask you to wear an activity monitor for the following 7 days at home. The monitor is a small device which is worn around your arm, and it measures your activity levels at home. We will arrange to collect this from you after you have finished wearing it. We will ask you to repeat the questionnaires and wearing of the activity monitor after 6 months, and then again 3 months later (9 months from starting the study and your final assessment). In addition to the questionnaires and activity monitor at 6 months and 9 months, we will ask you to attend the hospital to do some walking tests. These will be done at Glenfield Hospital. There will usually be three walking tests, which are done on a flat corridor, walking up and down a 10 metre course. It is usual to become breathless during these tests, however we will only ask you to do as much as you feel you can.
If you are assigned to the self-management group you will undergo the same assessments at the same time points as the usual care group. However, in addition to these we will also ask you to do the walking tests at all three time points (i.e. your first visit, 6 month visit and 9 month visit). These will all take place at Glenfield Hospital. In between your first visit and your 6 month visit we will ask you to attend the group sessions to introduce you to the selfmanagement programme. These will take place at a community centre. There will be approximately between six and 10 people in each group, and all sessions will be led by 2 healthcare professionals. Each session will last approximately two hours. At your first session you will be given the SPACE FOR COPD manual, and each session thereafter will discuss a different topic about how to manage with COPD. You will be advised how you can increase your activities at home, improve management of your breathlessness and learn what to do if you develop a chest infection. You do not have to discuss anything within the group if you do not wish to, and everything discussed within the group will be kept confidential. At the end of the self-management programme we will also ask you to take part in a focus group discussion where you will have an opportunity to discuss your experiences of the programme and whether you thought it was useful to you. The focus group will last  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y approximately 1 hour. The discussions will be audio recorded and transcribed for research purposes.
During the study, and immediately afterwards the study team will access your medical notes to obtain long term follow up data (for example GP visits, hospital admissions).
6. Are there any risks, disadvantages or side-effects of taking part?
We do not expect there are any risks to taking part in this study.
One potential disadvantage to taking part is the time you give to the study. Your first visit may take up to two hours. Your six-month and nine-month visits may take up to one hour each.
Whilst completing the walking tests, you may become short of breath, however we expect this will recover once you sit and rest. Afterwards, you may experience some achiness in your muscles and feel tired. This is usually only lasts a day or two.

What are the possible benefits of taking part?
We hope that the research will aid you in your understanding of COPD and how you can improve your symptoms. Information gathered will inform both present and future research, aiming to provide better care for people living with COPD.

What if something goes wrong?
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms would be available to you.
Should you wish to discuss any concerns about this study further, the Patient Information and Liaison Service is a point of contact for you. Their telephone number is 0808 178 8337.

Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you, which leaves the medical centre, will have your name and address removed so that you cannot be recognised from it. Some of your anonymised data will be shared with Insignia Health (a healthcare organisation) and entered onto a secure database to help improve patient outcome measures. This will be basic information, for example age, gender and some questionnaire data. Participants will not be identified in any subsequent written material. Results will be reported in such a way that completely preserves confidentiality. Data will be stored at Glenfield Hospital, and on University Hospitals of Leicester secure networks.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y We will, with your consent inform your GP of your participation in the trial and share with your GP any relevant test results that have been made during your participation in the trial.

1What will happen to the results of the research study?
The results of the study will be written in peer and lay journals, professional publications and presentations made at relevant conferences. Results will be reported in such a way that preserves confidentiality. All participants will also receive a summary of the results.

Who is organising and funding the research?
This study is being organised by staff employed at University Hospitals of Leicester NHS trust. It is being funded by a Collaboration and Leadership in Applied Health Research and Care East Midlands (CLAHRC).

Who has reviewed the study?
All research that involves the NHS is reviewed by an NHS Research Ethics Committee. This study has been reviewed and given a favourable opinion by Hampshire B research Ethics Committee. This does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information of which to make an informed decision. The study has also been reviewed and is sponsored by University Hospitals of Leicester.

Contact for further information
If you have any concerns or other questions about this study or the way it has been carried out, you should contact the principal researcher Professor Sally Singh: Roles and responsibilities 5a Names, affiliations, and roles of protocol contributors 1 5b Name and contact information for the trial sponsor 28 5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities 28 5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory) 9

Methods: Participants, interventions, and outcomes
Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained 9 Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) 10 Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be administered 11-16 11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease) N/A 11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests) 17 11d Relevant concomitant care and interventions that are permitted or prohibited during the trial 11 Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended

18-24
Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) 19 & diagram 1 Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions 10-11 Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned 10 Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions 10-11 Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how

& 19
17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial 11

Methods: Data collection, management, and analysis
Data collection methods 18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol

18-24 18b
Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols N/A Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol

24-26
Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol 25 20b Methods for any additional analyses (eg, subgroup and adjusted analyses) 25 20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) 25

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed N/A 21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial N/A

Harms 22
Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct 18 Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor N/A How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial 26 Declaration of interests 28 Financial and other competing interests for principal investigators for the overall trial and each study site 28