Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial

Objective To determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA). Design Six-month parallel group non-blinded randomised feasibility trial. Setting One secondary care and one primary care UK National Health Service Trust. Participants Fifty adults aged ≥55 years old with hip and/or knee OA. Interventions Participants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only. Outcome measures Key feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months. Results Ninety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group. Conclusions The feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures. Trial registration number ISRCTN:50675542.


Conclusion Adequate
: remove brackets from "n" Table 4: How is "effect" measured? Do you mean effect size? Add information in the fotnot on how effect or effect size is measured.

References
Add reference about the nested quality study

REVIEWER
K Cooper Robert Gordon University, School of Health Sciences REVIEW RETURNED 20-Feb-2021

GENERAL COMMENTS
Well done on a very well written manuscript reporting your interesting and important feasibility trial of peer mentorship to improve self-management of hip & knee OA. I just have a couple of comments that may enhance the manuscript: 1. Recruiting and screening potential peer mentors is a challenging aspect of this type of work. You report that those "assessed as suitable" were invited to the training (line 204) and also report that 11 were excluded due to "not meeting eligibility criteria" (Suppl figure  1). Can you provide any further details on this for the reader? Were the criteria only being aged 50+ and having hip/knee OA, or were any other strategies used during screening or training the peer mentors to determine their eligibility? Some previous studies have required participants to take a knoiwledge test or used observation of interpersonal sklls as additional criteria. Further detail on how you idenitifed people tio be suitable as peer mentors would be helpful for others doing work in this field. 2. Although the intervention is described well, I was surprised by the lack of underpinning theory, particularly when the overall aim is to change health behaviour. Presumably the rapid review of published literature identified several theory-based approaches to peer mentoring intervenions. perhaps something could be added to provide the reader with an understanding of the proposed mechanisms of action of the intervention.

VERSION 1 -AUTHOR RESPONSE
Reviewer: 1 Prof. Suzanne McDonough, University of Ulster Comments to the Author: This is well written report of a feasibility study that has been conducted with rigor. I have made some suggestions below for the authors to consider. The description of the intervention development needs to be enhanced particularly given the study aim to 'develop the intervention', so needs more detail in the methods and the results. I query the use of change data in PHI for your sample size, and would like less emphasis on discussion of clinical end points given the very small size of the study.
Line 183-is there a reference for the rapid review? This is important as it would appear that the main source of evidence for the intervention comes from one small study (ref 23) We did not publish the rapid review but we have now added further details about the rapid review and the intervention development process.
"The development and feasibility testing of the OA peer mentorship intervention was guided by the Medical Research Council guidance on developing and evaluating complex interventions [18]." (Methods; Page 5; Lines 119-121) "The OA peer mentorship intervention was developed in two stages. The first stage included a rapid review of published primary studies investigating one-to-one peer support interventions. The review aimed to identify: the range of methods and approaches used in delivering peer support interventions; training and support approaches for peer mentors involved in intervention delivery; and challenges of developing and implementing face-to-face peer support to improve self-management of long-term conditions. Using Medline, CINAHL & PsycInfo, a search of the literature between 2007 and 2018 was undertaken using the terms and synonyms "peer support", "long term condition" and "intervention". Thirteen papers were included [16,[24][25][26][27][28][29][30][31][32][33][34][35]. The findings highlighted the importance of encouraging a person-centred approach and retaining flexibility within the peer mentorship sessions. There was little information about "matching" the mentee with the peer mentor, although some studies based this on factors such as gender and age. There were issues around recruitment of peer mentors and a need to provide support and guidance to peer mentors throughout the intervention.
A preliminary version of the OA peer mentorship intervention was developed based on the rapid review findings and the following sources: • Guidelines on self-management and OA from organisations such as the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) and the UK charity Versus Arthritis.
• The "Staying Connected Programme"an arthritis self-management programme previously run by Arthritis Care Northern Ireland (now Versus Arthritis Northern Ireland). [36] • Input from project team members, including a consultant rheumatologist, a health psychologist and a physiotherapist specialising in activity pacing/chronic pain management.
The above sources were also used to develop a draft peer mentor educational resource pack. The pack was designed to supplement peer mentor training sessions and be used a resource during mentorship sessions. The pack included a range of handouts that peer mentors could give to participants." (Methods; Pages 8-9; Lines 181-121) 191-194-what was the process for refinement, and what were main changes made? It would be important to understand how the intervention was informed by the literature, and its theoretical underpinning. I would recommend https://www.ncbi.nlm.nih.gov/books/NBK540944/ on development of a peer led intervention for older adults. https://implementationscience.biomedcentral.com/articles/10.1186/s13012-016-0418-2 is also a very detailed paper on the development of a self management intervention in people with arthritis.
We have now added further details about how the intervention was refined.
"The second stage of the development process consisted of expert review sessions conducted with the following key stakeholders: study Patient and Public Involvement (PPI) members (n=2); other older individuals with OA (n=5); health professionals (n=4); voluntary/community organisation representatives (n=4); and researchers (n=2). Review sessions were conducted face-to-face (group, paired or individual meetings), via telephone or via email. The stakeholders were provided with information about the provisional OA peer mentorship intervention and a copy of the draft educational pack. Stakeholders" opinions of these were assessed using a pro forma.
Key refinements made based on the expert review sessions included: • Peer mentors were encouraged not cover too many topics in the first mentorship session to allow more time for developing rapport and managing participant expectations.
• Participants were provided with notebooks for recording goals, reflections and additional notes.
• The language used in the educational pack was simplified.
• Additional infographic handouts and further information on falls, local authority services and emotional well-being were added to the educational resource pack." (Methods; Pages 9-10; Lines 214-233) We have also provided further details about the content of the intervention and provided a logic model of the intervention.
"The finalised OA peer mentorship intervention aimed to improve participants" health outcomes through increasing their engagement with self-management behaviours. Figure 1 presents a logic model of the intervention, including the proposed mechanisms of action. The intervention involved up to eight one-hour self-management support sessions delivered by a trained peer mentor. During the sessions, the peer mentor provided guided support that incorporated multiple behaviour change techniques (BCTs) and covered a combination of core and optional topics (figure 1). In line with a person-centred approach, the implementation of BCTs and the choice and order of topics covered was flexible and participant-led. However, peer mentors were encouraged to cover all core topics at least once and set/review goals with the participant weekly. Online supplementary table 3 provides examples of the implementation of the key BCTs employed." (Methods; Pages 10-11; Lines 237-248) Furthermore, we have addressed the intervention development process in the discussion.
"In addition to drawing on the Staying Connected Programme, the development of the OA peer mentorship intervention incorporated multiple other sources and an expert review with key stakeholders. This approach, combined with extensive PPI, helped ensure the intervention is feasible, acceptable and focused on the needs of individuals with OA. The substantial investment in the development process will also maximise the chances of the intervention proving effective during a future definitive RCT. A potential limitation is that the development process was not based on a single behaviour change theory or theoretical framework. However, the broad range of sources considered and input from multidisciplinary experts helped ensure that the intervention has a sound theoretical basis (figure 1). In particular, the focus on enhancing self-efficacy is consistent with other peer support interventions aimed at improving chronic condition self-management.[24, 32, 56, 57]" (Discussion; Pages 31-32; Lines 647-658) 253-recorded in writing or how?
We have now added details of the recording format.
"Peer mentors completed a "session summary" in writing following each session, detailing the topics covered during that session, any challenges encountered and their reflections on the progress made." (Methods; Page 11; Lines 260-263) Line 269-provide a rationale for using PIH change scores from your feasibility for the sample size in a main trial, as my understanding is that this is not recommended (https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0493-7) Thank you for highlighting this interesting paper. We agree with the authors" conclusions that the decision about whether or not to proceed with a definitive trial should not be based solely on the effect sizes and confidence intervals of the feasibility trial. In line with this, we pre-specified four success criteria for proceeding to a definitive trial (Methods; Page 14; Table 1) based on relevant guidance (https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-10-1). These correspond with the key objectives of our feasibility trial, one of which was to generate the sample size needed for a definitive RCT.
Given the OA peer mentorship intervention we investigated has not been studied previously, we used the PIH scores from our feasibility trial for the sample size calculation. We have now clarified why we chose the PIH scores specifically.
"The PIH scale scores were used because the PIH scale was chosen as the provisional primary outcome measure." (Methods; Page 14; Table 1).
Lines 277-not clear why outcomes were measured after person being informed of their allocation?
We have now added further details about this.
"This approach was chosen due to the fluctuating availability of trained peer mentors. This meant there was sometimes a delay between participants being allocated to the intervention group and being able to commence their mentorship sessions. Therefore, most intervention group participants completed the baseline questionnaire with the Volunteer Coordinator immediately prior to their initial mentorship session to avoid a delay between completion of the baseline questionnaire and commencement of their mentorship sessions." (Methods; Page 15; Lines 323-329) We have also acknowledged this as a limitation in the discussion and highlighted how it could be addressed in a future trial.
"Another limitation of the present trial was that most participants were aware of their group allocation when completing the baseline questionnaire, which may have influenced their questionnaire responses.
[59] This could be overcome in a future definitive RCT by ensuring a greater number of trained peer mentors are available and/or administering the baseline questionnaire by post/online." (Discussion; Pages 32-33; Lines 674-677) I would prefer not to see inferential stats on the outcome data given the very small sample size e.g. line 502, and value of discussion section on this preliminary analysis is very limited, and the comparison with the Staying Connected study.
Thank you for this comment. We agree that caution is required when using inferential statistics on the outcome data. However, we believe that including the results of the exploratory analyses is worthwhile to provide readers with a preliminary insight into the potential effectiveness of the intervention. We have now expanded the discussion section on the preliminary analysis to clarify this.
"This trial included exploratory analyses of the impact of the OA peer mentorship intervention on patient-reported outcomes. These analyses provide a preliminary insight into the potential effectiveness of the intervention. However, the results must be interpreted cautiously because the present trial was not powered to detect statistically significant differences." (Discussion; Page 30; Lines 616-620).
We have also amended the discussion of the Staying Connected Programme.
"One such approach is the Staying Connected Programmea tailored one-to-one eight-week selfmanagement programme delivered by trained volunteers.
[36] A recent quasi-experimental study identified significant improvements in pain and arthritis-related self-efficacy amongst individuals with arthritis who participated in this programme.
[36] The Staying Connected Programme volunteers were not required to have an arthritis diagnosis, despite peer support being recognised as a valuable approach for supporting self-management. [11,12] In addition, the Staying Connected Programme aimed to support individuals with various types of arthritis and other long-term conditions [36]. The present trial"s intervention therefore aimed to replicate some key elements of the Staying Connected Programme whilst also incorporating peer support and being tailored specifically to the needs of people with OA. Although there are disparities between the findings of the present trial and the Staying Connected Programme study, neither was an adequately powered RCT. Future work is therefore required to determine the effectiveness of both the present trial"s OA peer mentorship intervention and the Staying Connected Programme." (Discussion; Page 31; Lines 630-645) Line 541, presumably you may include other regions in a multi centre trial so could recruit from a wider geographical spread for peer mentors?
We agree that recruiting peer mentors from a wider geographical area would be helpful for a future trial and have now clarified that in the discussion.
"These could include using multiple recruitment sites across a wider geographical area, recruiting mentors over a longer time-period, using snowballing recruitment with previously trained peer mentors and optimising recruitment through media outlets, such as magazine advertisements." (Discussion; Page 29; Lines 592-595) Introduction Appropriate.

Aim
Well described

Method
Page 5, line 113: please add a reference to where the nested qualitative study has been reported.
Our manuscript on the qualitative evaluation of the peer mentorship intervention has been accepted by Disability and Rehabilitation on the condition that this feasibility trial manuscript is accepted for publication. We are also currently preparing a manuscript on the qualitative interviews conducted with intervention group participants. We cannot therefore reference the nested qualitative study yet. We will however ensure that the present feasibility paper is referenced in the two planned publications of the nested qualitative study.
Page 6, line 126: please write the full name the first time an abbreviation is used (NHS).
We have now added this.
"Potential participants were identified from rheumatology and orthopaedic clinics of one secondary care National Health Service (NHS) Trust and physiotherapy clinics and electronic records of one primary care NHS Trust." (Methods; Page 6; Lines 127-129).
Page 9, line 204 and line 209: One compulsory two-day training event is mentioned as well as three training events. Are these the same or different events? What comprise the events of?
We have now clarified why we held three training events.
"Three training events were held due to varying peer mentor availability and staggering of the mentor recruitment, which meant it was not possible to train all mentors in one event." (Methods; Page 12; Lines 281-283) We have included a brief summary of the training events in the main manuscript text. Details of the specific areas covered are available in supplementary table 4.
"The training events involved presentations and interactive activities covering OA self-management topics, mentorship skills and the practicalities of the peer mentor role (online supplementary table 4)." (Methods; Page 12; Lines 291-293) In addition, we have written a separate manuscript reporting a qualitative evaluation of the peer mentorship intervention. The manuscript provides further details about the peer mentor training events and has been accepted by Disability and Rehabilitation on the condition that this feasibility trial manuscript is accepted for publication.
We would also like to highlight that we have made a minor change to the peer mentor flow diagram in supplementary figure 1 by adding a footnote to explain the following.
"One trained peer mentor who attended Training event 1 also attended Training event 3 as refresher training." (Supplementary figure 1) Page 9, line 205: Please explain what "Disclosure and Barring Service checks is, with reference.
We have now provided an explanation and reference for these checks. We have now provided further details of the content of the sessions in the text and logic model.
"During the sessions, the peer mentor provided guided support that incorporated multiple behaviour change techniques (BCTs) and covered a combination of core and optional topics (figure 1). In line with a person-centred approach, the implementation of BCTs and the choice and order of topics covered was flexible and participant-led. However, peer mentors were encouraged to cover all core topics at least once and set/review goals with the participant weekly. Online supplementary table 3 provides examples of the implementation of the key BCTs employed." (Methods; Pages 10-11; Lines 241-248) Page 13, line 270-273: is this a footnote to table 1?
Yeswe have now labelled this as " Table 1 Footnote" for clarity (Methods; Page 15; Line 311). We have also labelled the other table footnotes for consistency.
Page 15, line 324: The five dimensions in EQ5D is not scored on a 1-5 Likert scale. EQ5D comprise of questions that each has five possible answers, the answers is then converted do numbers which in turn is converted to the index.
Thank you for highlighting this. We have updated the description of the EQ-5D-5L accordingly. "The descriptive system includes five dimensions, each of which has five response levels. Each response is converted to a single-digit number. The numbers for each of the five dimensions can then be converted to a single index value anchored at 0 (a state equivalent to dead) and 1 (full health)." (Methods; Page 17; Lines 369-375) Please also include the reference by van Hunt that EuroQol recommend.
There is no van Hunt reference in the EQ-5D-5L user guide or on the EuroQol "EQ-5D-5L Key references" webpage (https://euroqol.org/publications/key-euroqol-references/eq-5d-5l/). We have added a reference by van Hout in case that is what you are referring to, as well as leaving in our original reference that is listed on the EuroQol "EQ-5D-5L Key references" webpage.

Results
Effect size is used in the results. A description of how effect size was calculated should be included in the method section.
We have described how the effect sizes were calculated in the Methods section.
"Between-group comparisons were made using ANCOVA models and, where the scores were significantly skewed, quantile regression models were used.

Discussion
Page 28, line 567: "no significant effects on pain and ASES". Patient Education programmes has shown to have effect on both pain and ASES, perhaps rephrase to clarify that it was the addition of peer-mentorship to the programme that did not have any effect on pain and ASES.
We have now clarified this.
"However, no significant effects of the OA peer mentorship intervention on other outcomes, such as pain and arthritis-related self-efficacy, were observed in the present trial." (Discussion; Page 30; Lines 622-624) Page 29, line 599: include reference to where the nested quality study is reported.
As explained above, the nested qualitative study is not yet published so we are not able to reference it at present. We will however ensure that the present feasibility paper is referenced in the two planned publications of the nested qualitative study.

Conclusion Adequate
Tables and figures  Table 2: remove brackets from "n" We have now removed the brackets. Table 4: How is "effect" measured? Do you mean effect size? Add information in the footnote on how effect or effect size is measured.
We have now clarified that we mean "effect size" (Results; Page 26; Table 4). Descriptions of how the outcome measures are scored are provided in the Methods section.
"Provisional primary outcome measure • Revised 12-Item Partners in Health (PIH) Scale: 12-item scale that assesses chronic condition selfmanagement.

Provisional secondary outcome measures
• Multidimensional Scale of Perceived Social Support (MSPSS): 12-item scale that assesses perceived social support from a significant other, family and friends.
[42] Each item is scored on a 7point Likert scale (1-7) and the mean for all items is calculated. Higher scores indicate greater perceived social support.
• Hospital Anxiety and Depression Scale (HADS): 14-item scale with two subscales that assess symptoms of anxiety (7 items) and depression (7 items).
• EQ-5D-5L: Descriptive system and visual analogue scale (VAS) that assess general health status. [48,49] The descriptive system includes five dimensions, each of which has five response levels. Each response is converted to a single-digit number. The numbers for each of the five dimensions can then be converted to a single index value anchored at 0 (a state equivalent to dead) and 1 (full health). The VAS consists of a single score on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (Methods; Pages 16-17; Lines 339-375)

References
Add reference about the nested quality study As explained above, the nested qualitative study is not yet published so we are not able to reference it at present. We will however ensure that the present feasibility paper is referenced in reports of the nested qualitative study.
Reviewer: 3 Dr. K Cooper, Robert Gordon University Comments to the Author: Well done on a very well written manuscript reporting your interesting and important feasibility trial of peer mentorship to improve self-management of hip & knee OA. I just have a couple of comments that may enhance the manuscript: 1. Recruiting and screening potential peer mentors is a challenging aspect of this type of work. You report that those "assessed as suitable" were invited to the training (line 204) and also report that 11 were excluded due to "not meeting eligibility criteria" (Suppl figure 1). Can you provide any further details on this for the reader? Were the criteria only being aged 50+ and having hip/knee OA, or were any other strategies used during screening or training the peer mentors to determine their eligibility? Some previous studies have required participants to take a knowledge test or used observation of interpersonal skills as additional criteria. Further detail on how you identified people to be suitable as peer mentors would be helpful for others doing work in this field.
Thank you for highlighting this important consideration. We have covered this only briefly in the present feasibility trial manuscript because we have written a separate manuscript reporting a qualitative evaluation of the peer mentorship intervention. The qualitative manuscript provides further details about the peer mentor recruitment process and has been accepted by Disability and Rehabilitation on the condition that this feasibility trial manuscript is accepted for publication.
Peer mentors were required to meet basic eligibility criteria (aged ≥50 years old, have hip and/or knee OA and be able to travel independently). We have now clarified this in the manuscript text.
"Peer mentors were trained volunteers aged ≥50 years old with hip and/or knee OA who were able to travel independently." (Methods; Page 11; Lines 267-268) In addition, suitability for the role (including appropriate interpersonal skills) was informally assessed both by the volunteers themselves and by the study team during the application process and training events. We did not require volunteers to undertake a knowledge test because the compulsory two-day training event focused on equipping volunteers with the knowledge and skills required for the peer mentor role.
2. Although the intervention is described well, I was surprised by the lack of underpinning theory, particularly when the overall aim is to change health behaviour. Presumably the rapid review of published literature identified several theory-based approaches to peer mentoring interventions. perhaps something could be added to provide the reader with an understanding of the proposed mechanisms of action of the intervention.
Thank you for this suggestion. We have now added further details about the proposed mechanisms of action of the intervention in the manuscript text and added a logic model of the intervention.
"The finalised OA peer mentorship intervention aimed to improve participants" health outcomes through increasing their engagement with self-management behaviours. Figure 1 presents a logic model of the intervention, including the proposed mechanisms of action. The intervention involved up to eight one-hour self-management support sessions delivered by a trained peer mentor. During the sessions, the peer mentor provided guided support that incorporated multiple behaviour change techniques (BCTs) and covered a combination of core and optional topics (figure 1). In line with a person-centred approach, the implementation of BCTs and the choice and order of topics covered was flexible and participant-led. However, peer mentors were encouraged to cover all core topics at least once and set/review goals with the participant weekly. Online supplementary table 3 provides examples of the implementation of the key BCTs employed." (Methods; Pages 10-11; Lines 237-248) In addition, we have also now addressed the intervention development in the discussion.
"In addition to drawing on the Staying Connected Programme, the development of the OA peer mentorship intervention incorporated multiple other sources and an expert review with key stakeholders. This approach, combined with extensive PPI, helped ensure the intervention is feasible, acceptable and focused on the needs of individuals with OA. The substantial investment in the development process will also maximise the chances of the intervention proving effective during a future definitive RCT. A potential limitation is that the development process was not based on a single behaviour change theory or theoretical framework. However, the broad range of sources considered and input from multidisciplinary experts helped ensure that the intervention has a sound theoretical basis (figure 1). In particular, the focus on enhancing self-efficacy is consistent with other peer support interventions aimed at improving chronic condition self-management. The five dimensions in EQ5D is not scored on a 1-5 Likert scale. EQ5D comprise of questions that each has five possible answers, the answers are then converted do numbers which in turn is converted to the index. Please also include the reference by van Hunt that EuroQol recommend.

Results
Effect size is used in the results. A description of how effect size was calculated should be included in the method section.

Discussion
Page 28, line 567: "no significant effects on pain and ASES". Patient Education programmes has shown to have effect on both pain and ASES, perhaps rephrase to clarify that it was the addition of peermentorship to the programme that did not have any effect on pain and ASES. Page 29, line 599: include reference to where the nested quality study is reported. Tables and figures  Table 2: remove brackets from "n" Table 4: How is "effect" measured? Do you mean effect size? Add information in the footnote on how effect or effect size is measured.

References
Add reference about the nested quality study

K Cooper
Robert Gordon University, School of Health Sciences REVIEW RETURNED 29-Mar-2021

GENERAL COMMENTS
Thank you for addresing my previous comments, the description of the theoretical underpinning for the intervention and the logic model in particular are very positive additions to this manuscript.