Remote peer mentorship in osteoarthritis
| ISRCTN | ISRCTN78088278 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78088278 |
| IRAS number | 326583 |
| Secondary identifying numbers | OBF/FR-000023819, IRAS 326583, CPMS 56341 |
- Submission date
- 10/05/2023
- Registration date
- 18/05/2023
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a common joint condition mainly affecting older people. Hip and knee osteoarthritis may cause high levels of pain, social isolation and difficulty with daily activities. Osteoarthritis is more common in people experiencing socioeconomic disadvantage. In this study the researchers are developing and testing a new support programme that will involve trained volunteers with osteoarthritis (‘peer mentors’) helping other people with osteoarthritis learn how to manage their condition better. The support will be delivered remotely and tailored to people who feel disadvantaged by their finances, education or social circumstances.
Who can participate?
People over 18 years of age and diagnosed with hip and/or knee osteoarthritis; and experiencing socioeconomic disadvantage
What does the study involve?
To develop the peer-mentorship intervention, the researchers will carry out focus groups with people with osteoarthritis who are experiencing socioeconomic disadvantage to find out what could affect the success of the peer-mentorship programme when delivered remotely. Through public engagement activities the researchers will develop and finalise the peer-mentorship programme. They will then recruit and train volunteer peer mentors to deliver to study participants the 6-week peer-mentorship programme. The researchers will then evaluate the peer-mentorship programme with study participants to see what they thought of the programme and whether it affected their health behaviours. They will also interview peer mentors to explore their experiences of receiving training, support and delivering the programme.
What are the possible benefits and risks of participating?
This research is trying to find out whether remote peer mentorship for osteoarthritis is of any benefit to people with hip and/or knee osteoarthritis who are experiencing socioeconomic disadvantage. This study involves receiving weekly support sessions from a trained volunteer (peer mentor) to support the self-management of osteoarthritis. Receiving this type of support may help people learn how to manage their symptoms due to osteoarthritis. There are no direct risks to taking part in the study as the intervention is about supporting and educating people living with osteoarthritis to self-manage. Taking part in the study does not involve a change to routine care.
Where is the study run from?
The study is run from the University of Leeds, but open to NHS recruitment within Leeds Community NHS Trust and also Primary Care within Yorkshire & Humberside. Recruitment via social media will be UK-wide.
When is the study starting and how long is it expected to run for?
February 2023 to December 2024
Who is funding the study?
1. Nuffield Foundation (UK)
2. Versus Arthritis (UK)
Who is the main contact?
Prof. Gretl McHugh, g.a.mchugh@leeds.ac.uk
Contact information
Principal Investigator
University of Leeds
Baines Wing
Leeds
LS2 9JT
United Kingdom
 ORCID ID |
0000-0002-5766-5885 |
|---|---|
| Phone | +44 (0)113 3431365 |
| G.A.McHugh@leeds.ac.uk |
Study information
| Study design | Multi-centre pragmatic mixed-methods feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Remote osteoarthritis peer-mentorship for socioeconomically underserved people |
| Study acronym | RaMIgO |
| Study objectives | To develop and assess the feasibility and perceived usefulness of a remote osteoarthritis (OA) peer-mentorship intervention for people with hip and knee OA who are experiencing socioeconomic disadvantage |
| Ethics approval(s) | Approved 02/06/2023, South Birmingham REC (South Birmingham Research Ethics Committee, Equinox House, City Link, Nottingham, NG2 4LA, UK; southbirmingham.rec@hra.nhs.uk), ref: 23/WM/0108 |
| Health condition(s) or problem(s) studied | Self-management of hip and/or knee osteoarthritis |
| Intervention | Phase 1: intervention development of an OA peer-mentorship intervention using qualitative research and participatory approaches. The researchers will carry out group discussions with people with osteoarthritis who are experiencing socioeconomic disadvantage to find out what could affect the success of the peer-mentorship programme when delivered remotely. They will then carry out public engagement activities with community groups and people experiencing socioeconomic disadvantage to develop and finalise the programme. Phase 2: intervention set-up which involves recruiting and training volunteer peer mentors to deliver the OA peer-mentorship intervention. The OA peer-mentorship intervention is supported by self-management education and guidance delivered to the study participants by trained Peer Mentors. Phase 3: Process evaluation using mixed methods which will investigate the acceptability appropriateness, feasibility, fidelity and adoption of the intervention. The volunteer peer mentors will deliver the programme to 25 participants with hip or knee osteoarthritis. The researchers will collect information about the participants’ health/wellbeing via questionnaires at the start of the programme. They will interview the participants immediately after they have completed the programme and again at 6 months. The interviews will explore areas such as what the participants thought of the programme and whether it affected their health behaviours. The researchers will also interview the peer mentors to explore their experiences of receiving training, support and delivering the programme. Finally, they will carry out two Stakeholder Discussion Forums to explore how we could put the mentorship programme into practice. |
| Intervention type | Other |
| Primary outcome measure | Completion of mentorship sessions assessed using completed data summary sheets at 6 weeks (at least 80% of peer mentor/participant matches complete six mentorship sessions) |
| Secondary outcome measures | 1. Demonstration that the osteoarthritis peer-mentorship can be delivered remotely, assessed using completed data summary sheets at 6 weeks 2. Acceptability of the intervention assessed using qualitative interviews post-intervention at 6 weeks and 6 months 3. Feasible solutions for addressing potential barriers to implementation of the intervention in practice, identified using two stakeholder discussion forums at the end of data collection (month 22) |
| Overall study start date | 01/02/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 95 Years |
| Sex | Both |
| Target number of participants | Phase 1: focus groups - 15 participants; process evaluation: 30 participants (Phase 3) |
| Total final enrolment | 52 |
| Key inclusion criteria | 1. Over 18 years of age 2. Diagnosed with hip/knee osteoarthritis by a health professional 3. Consider themselves to be experiencing socioeconomic disadvantage |
| Key exclusion criteria | 1. Inflammatory arthritis (including gout and rheumatoid arthritis) 2. Serious health condition that would prevent participation 3. Unable to participate in remote (telephone, video call) peer-mentorship |
| Date of first enrolment | 12/06/2023 |
| Date of final enrolment | 14/05/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
8 Victoria Road
Leeds
LS6 1PF
United Kingdom
Sponsor information
University/education
Secretariat
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 343 7587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal The researchers will share their findings with professionals and community stakeholders, including patients, through a written report, lay summary and infographic. This research is important and timely as people experiencing socioeconomic disadvantage are underserved by health services/research and may benefit most from self-management support. |
| IPD sharing plan | As some of the project data will include in-depth information about participants’ experiences and perspectives of receiving peer mentorship, and experiences of peer mentors involved in delivery mentorship (Phase 3), this data will not be made available as this will help ensure that participants’ identities remain confidential. The dataset from Phase 1: Focus Groups analysed during the current study will be stored in a publicly available repository: Research Data Leeds Repository (https://archive.researchdata.leeds.ac.uk). The type of data stored: anonymised qualitative data. The process for requesting access (if non-publicly available): Request access via a link provided in the repository file. Dates of availability: 01/06/2025 Whether consent from participants was required and obtained: Consent is required and will be obtained. Comments on data anonymization: Pseudonyms for names have been used; and any identifiable information anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/04/2023 | 17/05/2023 | No | No | |
| HRA research summary | 20/09/2023 | No | No |
Additional files
Editorial Notes
17/01/2025: The ethics approval was added.
30/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 14/05/2024.
2. The overall study end date was changed from 30/04/2025 to 31/12/2024.
3. Total final enrolment added.
20/09/2023: A link to the HRA research summary was added.
08/06/2023: The recruitment start date was changed from 01/06/2023 to 12/06/2023.
05/06/2023: Internal review.
19/05/2023: Internal review.
17/05/2023: Study's existence confirmed by the Nuffield Foundation.
