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Abstract
Introduction Heart failure (HF) as a long-term clinical syndrome is associated with inadequate self-care behaviours, a feeling of uncertainty and frequent hospitalisation. In recent years, empowerment has evolved for improving chronic disease management. Nevertheless, there is a lack of studies investigating remote care interventions such as a tele-empowerment programme in patients with HF. Therefore, this protocol proposes a randomised controlled trial which aims to evaluate the effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission in patients with HF.
Methods and analysis The study is a double-arm and parallel-group randomised controlled trial in which a 10-week intervention, including 6 weeks of a comprehensive tele-empowerment programme and 4 weeks of follow-up, will be compared with usual care. A total of 96 eligible patients with HF will be recruited and randomly assigned to the intervention or control group. The patients in the intervention group will join virtual groups and receive the five-step tele-empowerment programme through the internet. The primary outcomes include self-care behaviours and uncertainty which will be measured with valid instruments at baseline and 10th week. The secondary outcome is the number of patients’ hospital readmissions and will be assessed at the end of the study. Descriptive statistics will be used to describe variables. According to the types of variables, appropriate statistical tests including two-sample t-tests, Χ2, analysis of covariance or linear regression will be performed. In addition, standardised intervention effect sizes will be calculated for each outcome.
Ethics and dissemination The trial has been approved by the Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation at Tehran University of Medical Sciences. In this study, written consent will be obtained from all participants. The results will be presented to representative groups and published in peer-reviewed journals.
Trial registration number Iranian Registry of Clinical Trials (IRCT20100725004443N30).
- Telemedicine
- Heart failure
- Self Care
- Nursing Care
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This nurse-led, two-arm, randomised controlled trial evaluates the effectiveness of a novel entirely remote empowerment programme on self-care behaviours, uncertainty and readmissions of patients with heart failure (HF), for which experimental evaluations are lacking.
The five-step patient-centred tele-empowerment programme has been developed by an academic-clinical multidisciplinary team to propose a precise and comprehensive approach to improve disease-related decision-making and problem-solving skills in patients with HF.
Given that HF affects all aspects of health, the comprehensive tele-empowerment programme is designed to address the needs of all three dimensions of the patients including physical, psychological and spiritual.
Attrition and inadequate adherence are possible risks in remote interventions; however, we strive to encourage patients to remain in the programme by providing them with informative and practical content, appropriate guidance and continuous follow-up throughout the study.
Due to the nature of the intervention, only the outcome assessor and statistician will be blinded in this study.
Introduction
Heart failure (HF) is a complex clinical syndrome characterised by a disorder in which the heart fails to pump or fill with blood, and physiologically, it can be defined as insufficient cardiac output to meet metabolic demands.1 HF is estimated to have affected more than 64 million people worldwide.2 In Iran, the prevalence of this disease is estimated to be about 8% of the general population, which is higher than many other countries.3 Moreover, the number of patients with HF continues to rise as a result of population growth and ageing, making it an increasingly serious public health concern.4 The overwhelmingly growing prevalence of HF directly culminates in increasingly economic costs and treatment burdens on healthcare systems.1 The annual median medical costs associated with HF care in the USA were estimated to be $24 383 per patient.5 Meanwhile, there is evidence that the economic burden induced by this disease is even higher in Asian countries.6
The patients with HF may experience such a wide range of clinical symptoms associated with frequent hospitalisation and poor prognosis that 24% of them are readmitted within 3 months after an initial hospital discharge.7 The treatment of HF typically involves a complex medication regimen, symptom monitoring and lifestyle modification, all of which are essential for enhancing functional capacity, improving the quality of life, and reducing complications and mortalities in patients.8 As a result, after the diagnosis of HF, patients frequently encounter complex and chronic conditions in which special measures are required to improve self-care behaviours so that they can adapt themselves to the new circumstances.9 Self-care is a process of a patient’s participation in taking responsibility for improving different aspects of health and adopting certain behaviours to manage the disease and limit consequences.10 Given that HF affects all aspects of health, self-care behaviours need to address physical, psychological and spiritual well-being.11 Despite the emphasis given by HF guidelines on improving self-care in patients with HF,12 self-care behaviours are not adequately performed by these patients.10 13
Furthermore, HF as a long-term disorder is associated with periodical exacerbation, uncertain illness trajectories and complicated treatment regimens, which can lead to a feeling of ambiguity and uncertainty in the patients.14 The concept of ‘uncertainty in illness’ was defined for the first time by Merle Mishel as the difficulty in pinpointing the disease-related symptoms or the inability to accurately predict disease outcomes.15 This disease-induced state is considered to be a natural aspect of the patients’ experience and can have dramatic effects on the psychological adaptation and the disease outcomes.16 The high level of uncertainty can adversely affect the patients’ quality of life, reduce their ability to deal with illness and result in mental issues such as anxiety and depression.17
Therefore, it is important for the patients with HF to be provided with adequate information and be empowered to better control their disease and modify their lifestyle.18 In recent years, empowerment has evolved to use a patient-centred approach for improving chronic disease management with the aim of increasing the patients’ own ability to think critically and function independently.18 19 The WHO defines empowerment as an interactive process to enhance a person’s control over health-effective decisions and actions, and considers it as a prerequisite for health promotion.20 The nurses’ professional expertise and their close relationship with patients make them responsible for educating patients to develop a suitable lifestyle and empowering them through various methods. This is especially the case for the ones suffering from chronic diseases.21
In both developed and developing countries, interventions focusing on self-care behaviours and controlling certain modifiable variables are needed to reduce the progression of disease and improve the quality of lives of patients with HF.22 In addition, there has been a reduction in the number of visits to health centres during COVID-19 pandemic, which has challenged the healthcare systems for providing care to chronic patients and necessitated innovations.21 23 Internet-based methods and digital approaches were given special attention during COVID-19 as a complementary solution for providing treatment and care services.24 25 Multiple restrictions in the pandemic period highlighted the importance of providing telecare services as a promising care strategy that may become a new routine approach even after the pandemic.26 Through the use of internet-based and remote methods such as a tele-empowerment programme, high-quality, safe, fast and cost-effective care can be provided to address many of the patients’ problems.27
Although a few studies have been conducted in the field of empowerment and its effects on patients with HF,18 28 there is a lack of studies investigating remote care interventions such as a tele-empowerment programme in these patients. Furthermore, having examined the literature in this area, we found that empowerment programmes for cardiac patients mainly focus on monitoring and managing the patient’s physical condition, and few interventions comprehensively include the physical, psychological and spiritual dimensions of the patient.28–30 Therefore, we developed a randomised controlled trial (RCT) to evaluate the effectiveness of a comprehensive tele-empowerment programme addressing physical, psychological and spiritual dimensions on self-care behaviours, uncertainty and readmission in patients living with HF.
Methods and analysis
Study design
This study is a double-arm and parallel-group RCT. Figure 1 illustrates an overview of the study design in a flow chart. This protocol has been prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guideline.31
Flow chart of study design overview. EHFScBS-9, nine-item European Heart Failure Self-Care Behavior Scale; HF, heart failure; IKHC, Imam Khomeini Hospital Complex; MUIS-C, Mishel Uncertainty in Illness Scale-Community form.
Study setting
Recruitment will be conducted at the HF clinic of Imam Khomeini Hospital Complex (IKHC), affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. IKHC is one of the largest government-owned hospitals as well as a referral centre providing specialised services.
Eligibility criteria
The patients with a diagnosis of HF referred to the HF clinic will be screened for the following eligibility criteria:
Inclusion criteria
The study inclusion criteria include: (1) age range between 18 and 65 years, (2) determined diagnosis of class II or III heart failure (according to the New York Heart Association (NYHA) classification), (3) medical diagnosis of chronic HF for at least 3 months, (4) ability to read and write Persian language, (5) access and ability to use smartphones and the internet, and (6) willingness to participate and complete intervention sessions, social media group interactions and data collection measures.
Exclusion criteria
Exclusion criteria for the study include: (1) diagnosed mental and cognitive disorders documented in the medical record, (2) having vision, hearing or speaking deficits, (3) participation in or experience of joining similar empowerment programmes, (4) HF exacerbation or end-stage HF and (5) reporting an experience of severe psychological distress during the study period. Concerning item 5, in order to comply with ethical considerations, these patients will continue to receive the intervention if they wish; however, their data will be excluded in the analysis step due to the potential effects of experiencing severe psychological distress on the patient’s compliance with the study and self-care procedures. Patients reporting such conditions will also be provided with information on how to contact the counselling centres of TUMS in order to seek assistance in dealing with their distress as required.
Interventions
This study consists of a 10-week nurse-led intervention. In this study, patient eligibility will be determined in a face-to-face visit by an HF specialist and a nurse interventionist. Participants who meet the eligibility criteria will be included in the study if they consent to participate. Next, the participants will be randomly assigned to intervention or control groups. The patients in the control group will receive usual care, whereas the patients in the intervention group will receive 10 weeks of intervention, including 6 weeks of a comprehensive tele-empowerment programme and 4 weeks of follow-up in addition to their usual care (figure 1). During this visit, participants in the intervention group will be asked to indicate their preferred times in the week for attending the online sessions of the programme. Furthermore, an educational booklet containing six sections (in accordance with the weekly topic of the 6-week empowerment programme) and instruction on implementing empowerment programme steps (along with examples) will be provided to the patients of the intervention group in this session.
The comprehensive tele-empowerment programme
Initially, the patients in the intervention group (a cluster of 10–15 participants at a time; four clusters per trial) will join virtual groups on a internet-based electronic messaging platform, and then receive the comprehensive tele-empowerment programme over the 6 weeks. The empowerment programme is designed to meet the physical, psychological and spiritual needs of the patients. Each week, a specific topic will be addressed to promote the patients’ self-care, and the weekly educational content will be made available to the intervention group as online/offline sessions (three online and three offline sessions). In offline sessions, educational videos lasting for 10–20 minutes will be sent to the virtual groups. In online sessions, the Skyroom (an Iranian webinar platform) link will be placed in the virtual group to synchronous sessions that last for 45–60 minutes on average. The Skyroom platform also provides the patients with the opportunity to share their questions and opinions regarding the discussed topic as well as listen to the opinions of other patients in relation to the topic. Online sessions will be held according to the agreement of the members of each group, in order to ensure that participants are able to attend. However, in the event that a participant is unable to attend an online session or experiences disconnections during the session, we will provide the participant with a recording of the original online session. Additionally, if required, we will offer the participant an online session lasting for 15–30 minutes to explain key content from the missed session so that he/she is fully informed.
Table 1 outlines the topics of each week and provides further details. In this study, the educational content is developed according to the international HF guidelines and recommendations published by the American Heart Association, as well as reliable scientific sources, and approved by five nursing faculty members and an HF specialist.
Descriptions of topics and educational sessions during 6 weeks of the comprehensive tele-empowerment programme
The empowerment process focuses on increasing motivation among the patients, assisting them in setting goals, encouraging active participation in decision-making and assisting them in attaining their goals. The study team has drawn from the existing literature on patient empowerment and self-care promotion programmes,18 30 32 33 as well as expert consultation to develop a five-step empowerment programme with the following steps: (1) needs assessment, (2) goal setting, (3) structured education, (4) self-care plan development and (5) evaluation, all of which will be implemented by the nurse interventionist on the internet-based electronic messaging platform in weekly sessions. Participants in the intervention group will be instructed on how to implement empowerment steps during the initial face-to-face visit and by instructions provided in the educational booklet. These five steps are described as follows:
Needs assessment: this step will be taken before the educational sessions, during which the patient will be encouraged to talk or ask about his/her needs, problems and concerns related to the topic of the week and then list them. This information will be privately sent to the nurse interventionist in the form of tailored text or voice messages on the electronic messaging platform.
Goal setting: the patient will review his/her problems that were raised in the first step and set goals to modify lifestyle choices, remove obstacles or manage the mentioned concerns with guidance from the nurse interventionist. The nurse interventionist will help each patient create realistic and achievable goals based on his/her individual needs and preferences.
Structured education: in this step, the nurse interventionist provides structured education regarding the specific self-care topic of the week through offline/online sessions (see table 1). After presenting the educational content, related scenarios will be set forth and the patients will be encouraged to share their views with peers and provide suitable solutions in their virtual groups.
Self-care plan development: to achieve the goals and address the identified HF-related issues, the patient actively presents different solutions informed by the education content of step 3. In this step, the nurse interventionist guides the patients in developing their self-care plan and encourages them to follow their plan.
Evaluation: one week after holding the educational session and determining the self-care plan, the nurse interventionist will send a message to nudge and check the progress of the patient in their self-care plan and goals.
While goal setting and self-care plan development seem closely related, goal setting is an important initial step in helping patients identify specific areas of focus for achieving their desired outcomes. Once the goals have been established and structured education has been received, the self-care plan development step focuses on determining specific self-care behaviours and strategies that can help patients to achieve their goals.
The diagram of the comprehensive tele-empowerment programme is shown in figure 2.
Diagram of the comprehensive tele-empowerment programme (intervention group).
Follow-up
The patients in the intervention group will be followed up for 4 weeks after the 6-week tele-empowerment programme (figure 2). The weekly follow-up will be done through a 5–10 min phone call by the nurse interventionist. The purpose of this phone call is to appraise and promote the participant’s application of the intervention skills and content to their daily life. In each follow-up call, in addition to answering the patient’s questions, the nurse examines the level of achievement of previously determined goals, highlights the benefits of self-care, identifies the concerns and obstacles in implementing what has been learnt, and reviews the problem-solving methods.
The 4-week follow-up period has been considered appropriate in several studies,34–37 and the study team chose this duration based on previous literature as well as facilities’ constraints and accessibility to patients. Nevertheless, the team plans to assess the effectiveness of this arrangement by performing an interim analysis and extending the follow-up period if necessary. In addition, the 6+4 weeks’ duration was chosen to strike a balance between providing sufficient time for patients to learn and practise self-care skills and minimise the burden on patients and healthcare providers.
Usual care
The patients in the control group do not receive any intervention from the nurse interventionist, and after the initial visit, they will receive routine HF care. Usual care for patients with HF generally involves regular in-person visits with HF specialist and basic instructions on dietary habits, physical activities and prescribed medications.
Outcome measures
The effectiveness of the 10-week intervention on the outcomes of the study will be investigated:
Primary outcomes
The primary outcomes (measured variables) of this study will include (1) self-care behaviours and (2) uncertainty.
Self-care behaviours will be measured by the nine-item European Heart Failure Self-Care Behavior Scale (EHFScBS-9), which is one of the most widely used tools to assess self-care behaviour in patients with HF. This questionnaire includes nine items, each of which is rated on a 5-point Likert scale ranging from 1 (I completely agree) to 5 (I don’t agree at all). The overall score ranges from 9 to 45, and lower scores indicate better self-care.38 Negarandeh et al evaluated and confirmed the validity and reliability of the Persian version of EHFScBS-9.39
The measurement of uncertainty will be accomplished using the Mishel Uncertainty in Illness Scale-Community form (MUIS-C) questionnaire, which is developed by Mishel and Epstein in 1997.40 The MUIS-C version of this questionnaire is designed for non-hospitalised patients with chronic illness and measures the patient’s perceptions of uncertainty about symptoms, diagnosis and treatment. This instrument is a 23-item self-report tool with a Likert scoring range from 1 (completely disagree) to 5 (completely agree). Total scores range from 23 to 115, with a higher score indicating greater uncertainty. The MUIS-C has also been used to measure uncertainty in patients with HF.14 41 The validity and reliability of the Persian version of MUIS-C have also been confirmed by Biglar Chopoghlou et al,17 and employed in several studies.42–44
Secondary outcome
Secondary outcome will be the number of the patients’ hospital readmissions. In this study, readmission refers to emergency and unexpected readmissions due to the deterioration of symptoms or progression of HF. Immediately after the study, the outcome assessor will ask the participants of both groups about the number of readmissions that they had during the study. The data will be obtained based on participants’ self-reports and confirmed by checking the hospital information system in case of readmission to IKHC or by reviewing medical records in case of readmission to other health centres.
Data collection
The data will be collected using a demographic information questionnaire, EHFScBS-9 and MUIS-C, as well as a question about the number of readmissions. The demographic information of the patients will be obtained through a self-report questionnaire and medical records at the beginning of the study. The EHFScBS-9 and MUIS-C will be filled out by the participants at the beginning and end of the study (baseline and 10th week) (figure 1). The baseline questionnaires will be completed in person during the face-to-face session, and in the 10th week, the link to the online version of the determined questionnaires will be sent to the patients via the electronic messaging platform. Furthermore, a question regarding the number of emergency readmissions will be asked through a phone call by the outcome assessor at the end of the study.
Table 2 provides the schedule for enrolment, interventions and assessments in the present study.
Schedule for enrolment, interventions and assessments in this study
Sample size
The primary outcomes of our study are self-care and uncertainty, with self-care designated as the primary outcome for sample size calculation. Assuming the first-type error of 5% and power of 80%, the sample size determined is 43 patients in each group based on the study of Shearer et al,29 considering the average of 19.6±2.15 and 18.03±2.95 in the intervention and control groups, respectively. Considering a possible 10% attrition rate, the estimated number of participants in this study is n=48 patients per group and a total sample size of 96 patients.
Recruitment
The participants will be recruited in person at the HF clinic of IKHC. The patients referred to the clinic will be screened for eligibility by the nurse interventionist and HF specialist, and the patients who meet the eligibility criteria will be provided with additional information about the study. During this session, the patients who fulfil the inclusion criteria will be randomly assigned to the control or intervention group by nurse interventionists. The participants will be requested to fill out written informed consent after explaining the details of intervention. In addition, these patients will be encouraged to follow the study timeline per protocol, and to minimise the risk of contamination across arms, they will be requested not to share the information received in the empowerment programme with other patients. The intervention will be delivered after the formation of each cluster of 10–15 participants, and recruitment for the study will continue until the required sample size is reached.
Random allocation
The participants will be randomly assigned to control or intervention groups by using balanced block randomisation method. Block size will be four and it will be stratified by gender and NYHA classification of HF in order to maintain balance in the allocation of individuals to the two groups (allocation ratio N2/N1=1). The assignment sequence will be generated by a researcher who is not involved in the recruitment or assessment. Allocation concealment was ensured using sealed opaque envelopes, with a unique identifier and allocation sequence number written on the outside of each envelope.
Blinding
The nature of this intervention prevents blinding participants and nurse interventionists. Nevertheless, the outcome assessor will act independently from nurse interventionists in this study. The outcome assessor and statistician will be blinded and instructed not to inquire about whether the participants had received the intervention.
Data management
The baseline data will be collected in paper format at the beginning of the study and the final data will be collected in an online format in the 10th week by the outcome assessor. In order to prevent and minimise missing data, patients will be encouraged and followed up to fill out questionnaires in the second stage, and the outcome assessor will also be trained to ensure that the data are collected and documented accurately and completely. To ensure that the participants fill out the online questionnaires at the end of the study, the outcome assessor will contact the participants by phone to explain the importance of completing the questionnaires and assist them with the task completion. The data entry into SPSS software V.23 will be performed by a trained researcher and double-checked by another member of the research team. In order to maintain the participant confidentiality, the data will be stored using anonymised ID code numbers. Finally, data analysis will be conducted by an epidemiologist statistician.
Statistical analysis
Numerical variables will be described by mean and SD (or median and IQR) and categorical variables will be described by frequency tables (including percentages). To determine the normality of the data distribution, the non-parametric Kolmogorov-Smirnov test will be used. The intention-to-treat analysis will be conducted on all randomised subjects to avoid the effects of dropout on the comparison made between the intervention and usual care groups. If required, the use of regression models and mean imputation will also be considered to predict missing data.
Two-sample t-tests, Mann-Whitney, Χ2 or Fisher’s exact tests will be used as appropriate depending on types of variables. The analysis of covariance or linear regression will be performed on adjusted confounding variables. The interim analysis will be performed to determine the efficacy of the 10-week study. In addition, the standardised intervention effect sizes will be calculated for each outcome based on the baseline SDs. The analyses will be carried out with the SPSS software V.23 and values of p<0.05 will be considered as statistically significant for all tests.
Discussion
As a chronic and debilitating disease, HF can weaken the ability of self-care,10 cause uncertainty about the disease14 and lead to frequent hospitalisation in the patients.7 Therefore, new approaches are needed to empower patients with HF and improve their self-care behaviours. Hence, this protocol describes the design of a clinical trial to test the effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission in patients with HF.
The empowerment programme recognises patients as active participants in the management of their disease and consists of a collaborative approach in which information, guidance and support are provided by the nurses to enable the patients to make the best decisions for self-care activities.29 Most studies conducted in the field of empowerment of heart patients focused primarily on physical issues of the patients.28–30 However, heart disease, particularly HF, affects patients in all aspects, including physical, psychological and spiritual functioning,11 which should be taken into account comprehensively when implementing empowerment programmes. Furthermore, many of the empowerment programmes involved several face-to-face sessions during the implementation of the programme,18 28 30 with few studies examining entirely remote or internet-based empowerment programmes in cardiac patients. Meanwhile, the presence of multiple face-to-face sessions during an empowerment programme may result in difficulties and limitations in the continuous access and regular performance among the patients. However, applying remote approaches may be more practical and attractive for patients due to the increasing use of the internet and its accessibility potential.27 Moreover, the COVID-19 pandemic and its related restrictions have reinforced the importance of designing and implementing tele-empowerment programmes.25
We anticipate that the five-step tele-empowerment programme will help the patients gain a better understanding of HF and enhance their ability to manage the symptoms and HF-related complications. By providing comprehensive information about self-care strategies in physical, mental and spiritual dimensions and practising the application of that content during the five steps of the empowerment programme, this intervention may improve their disease-related decision-making and problem-solving skills.
Like any other study, this study is not without limitations. Although we have attempted to mitigate these limitations, some issues may still arise as constraints of the study. For instance, although internet access and demand for telehealth care among patients have increased, since participants must have a basic level of digital literacy and access to the internet, the generalisability of the results to all patients may be limited. Additionally, due to the nature of the intervention, the study is not blinded to participants and interventionists. Nevertheless, outcome assessors and the statistician will remain blinded in the study. Attrition and inadequate adherence are potential risks in remote interventions. However, we strive to encourage patients to remain engaged in the programme by providing useful and practical information, appropriate guidance and continuous follow-up throughout the study.
In this study, we hypothesise that the comprehensive tele-empowerment programme will improve self-care behaviours, decrease uncertainty about illness and reduce emergency readmissions in patients with HF. If the results of this research provide positive effects, this tele-empowerment programme will benefit patients with HF and can be applicable to the Iranian context and other countries.
Patient and public involvement
There was no patient and public involvement in the development of this protocol. A group of patients with HF voluntarily cooperated in design of the study by perusing the educational contents and providing their comments by reliance on their daily needs and experiences.
Ethics and dissemination
Approval has been obtained from the Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation at TUMS on 9 February 2022 (no. IR.TUMS.FNM.REC.1400.194). The protocol of this study was also registered in Iranian Registry of Clinical Trials (IRCT), and the registration ID is IRCT20100725004443N30. Written consent will be obtained from all participants and they will be fully informed about their rights of voluntary enrolment and withdraw. The data will be handled and stored in a confidential and anonymous manner. The patients will be provided with the contact information of the nurse (the researcher) who could assist them in case of any query. In accordance with ethical considerations, all the educational contents of the empowerment programme along with the electronic version of the educational booklet will be sent to the patients of the control group after the completion of the study and data collection. We aim to present the findings to the representative groups and publish the results of the trial in peer-reviewed journals.
Trial status
The recruitment of participants has been started in February 2023. The estimated end date of the recruitment for this study is July 2023.
Ethics statements
Patient consent for publication
Acknowledgments
This protocol study pertains to AK-K’s MSc thesis in Medical-Surgical Nursing at TUMS. We would like to acknowledge the contributions of Education and Research Deputy and the Medical-Surgical Nursing Department of the School of Nursing and Midwifery affiliated with TUMS to the thesis approval and their ongoing support.
References
Footnotes
Contributors AK-K serves as the principal executive of the trial and MZ is the supervisor of the project. AK-K, SG, SM, MK, RW and MZ conceived the project. Implementation will be conducted by AK-K, AM and SM. SM is an HF specialist at IKHC and will also assist with reviewing educational contents and confirming the patients’ eligibility for inclusion. AK-K, AM, SG and MZ will be involved in the preparation of educational contents. MK will provide statistical expertise in clinical trial design and perform statistical analysis. All authors have contributed to the preparation of this paper and approved the final manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.