Condition category
Musculoskeletal Diseases
Date applied
08/05/2017
Date assigned
22/05/2017
Last edited
03/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common form of arthritis. It occurs when the protective cartilage on the end of bones wears away, causing the bones to rub against one another, which can cause stiffness, pain and a reduction in a person’s range of movement. The physical symptoms can greatly reduce quality of life in sufferers, even leading to social isolation. The government has highlighted the need for individuals to manage their long-term condition themselves by providing the support for people to take care of their own health. There is evidence that ‘peer support’ can assist with improving management of long-term conditions. A peer mentor is usually someone who has the condition but has undergone training to be able to provide focused assistance and mentorship to someone who also has the condition. Peer mentorship appears to work well with supporting individuals with other conditions such as diabetes and in mental health but it hasn’t been developed or tested for individuals with osteoarthritis, only for inflammatory arthritis. The aim of this study is to develop and evaluate the feasibility of a peer support model (OA mentor) to improve self-management of individuals with OA.

Who can participate?
Adults aged 55 and over who have confirmed OA of the knee or hip.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an information booklet, and a researcher will visit the participants to guide them through this which provides useful tips on how to manage the symptoms of osteoarthritis. Those in the second group receive weekly visits for eight weeks from a trained volunteer (known as a ‘peer mentor’) who works with participants to help them manage their osteoarthritis more effectively. This involves visiting the participant at home for up to one hour each week over eight weeks. For whichever type of support the participants receive, a questionnaire is completed to collect information about length of time with OA, medication, pain, mobility, mood and quality of life initially, at eight weeks and then again six months later. The participants are visited by a member of the research team for questionnaire completion at eight weeks; and at six months the participants receive the questionnaire by post to complete.
In order to assess the acceptability and feasibility of the peer mentor programme, a sample of participants take part in face to face interviews six months after the end of the study. In addition, a selection of the peer mentors are also interviewed after delivering the eight week programme.

What are the possible benefits and risks of participating?
Participants may find that there are no direct benefits to taking part in this research. However, this research will be helping to try out these different types of support and to see whether these are of any benefit. If it is found that one type of support is showing positive benefits over the other, it will be the intention to develop this further to see what exactly the benefits are in receiving the booklet as compared to having a volunteer mentor to support individuals with their osteoarthritis. There are no notable risks involved with participating.

Where is the study run from?
Chapel Allerton Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2017 to January 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Gretl McHugh
g.a.mchugh@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gretl McHugh

ORCID ID

http://orcid.org/0000-0002-5766-5885

Contact details

Faculty of Medicine & Health
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 113 343 1365
g.a.mchugh@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34479

Study information

Scientific title

Developing peer Mentorship to Improve self-management of Osteoarthritis: A feasibility study (aMIgO)

Acronym

aMIgO

Study hypothesis

Study aim:
The aim of this research is to develop and evaluate a peer support model (OA mentor) to improve self-management of individuals with osteoarthritis through a feasibility study.

Hypothesis:
A peer mentorship intervention can be delivered at home and is acceptable to individuals with osteoarthritis; and the protocol for a definitive randomised controlled trial is feasible in terms of recruitment and retention and collection of relevant outcome data.

Ethics approval

North West - Greater Manchester South Research Ethics Committee, 18/05/2017, ref: 17/NW/0238

Study design

Randomised; Interventional; Design type: Process of Care, Education or Self-Management, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Non-inflammatory Joint Disorders; UKCRC code/ Disease: Musculoskeletal/ Arthrosis

Intervention

Feasibility study:
Patients recruited to the study will be randomised into one of two arms, standard care or the intervention package. Random allocation sequences with varying block length stratified by educational level will be generated by the statistician using nQuery Advisor 6.0.

Control group: Participants receive standard care. This involves receiving usual advice and follow-up for their osteoarthritis (OA) with a leaflet provided about their OA.

Intervention group: Participants receive the peer mentor intervention. This involves weekly visits by the OA mentor for 8 weeks, providing guided support which will focus on: exercises for OA; information about OA, healthy eating, pacing; pain management and learning about goal setting. The individual will be assessed by the peer mentor on the first visit and will work with the mentor to ensure support and mentorship is tailored.

Follow up involves participants to complete a questionnaire at 8 weeks with support from the member of the research team visiting the participant at home; the participant will then received the final follow-up questionnaire at six months and asked to return the completed questionnaire by post or email.

Nested Qualitative study:
To assess the acceptability and feasibility of this peer-mentorship intervention, a qualitative study will be undertaken and will interview a purposive sample of the intervention participants (n~15) after completion of the 6-month feasibility trial follow-up. Face-to-face interviews will be conducted with the sample of participants and will gather data on the usefulness and how acceptable has been and whether the support sessions were done at the right intervals and using an appropriate approach. We will also interview the 7 volunteer peer Osteoarthritis mentors using semi-strutted interview to get information on the mentorship and training provide. These interviews will be undertaken after the 8 week mentorship programme they deliver.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The primary outcome will be informed by the results of the feasibility study. Candidate variables for the primary outcome will be:
1. Self-management as measured by the Partners in Health Scale Questionnaire at baseline, 8 weeks and 6 months
2. Physical function as measured by the Western Ontario and McMaster's University (WOMAC) Osteoarthritis Index questionnaire at baseline, 8 weeks and 6 months
3. Pain as measured by the Western Ontario and McMaster's University (WOMAC) Osteoarthritis Index questionnaire at baseline , 8 weeks and 6 months
4. Health status as measured by the EQ-5D-5L (EuroQoL Group) at baseline, 8 weeks and 6 months
5. Social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) at baseline, 8 weeks and 6 months
6. Self-efficacy as measured by the Arthritis Self-Efficacy Scale at baseline, 8 weeks and 6 months
7. Anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) at baseline 8 weeks and 6 months

Secondary outcome measures

Other feasibility outcomes
1. Recruitment rate will be recorded as the number of eligible participants who consent to participate in the study
2. attrition rate will be recorded as the number of participants who consent to participate who remain in the study until the end of follow-up at six months
3. Health-related resource use will be recorded as mean health related resource use collected using questions pertaining to health and social care usage at 8 weeks and 6 months

Qualitative study:
Evaluation of the acceptability peer-mentorship intervention as explored by the qualitative interviews of intervention participants after completion of the 6-month feasibility trial follow-up.

Overall trial start date

01/05/2017

Overall trial end date

31/05/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 55 years or over
2. Male and female
3. Confirmed osteoarthritis of the hip or knee

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Patients who are experiencing other rheumatologic conditions
2. Other serious health conditions that prevent participation
3. On the waiting list for a hip or knee replacement

Recruitment start date

01/09/2017

Recruitment end date

29/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Faculty of Medicine & Health Research Office
Level 9
Room 9.29
Worsley Building
Leeds
LS2 9JT
United Kingdom
+44 113 343 4897
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer review journals and this will be during late 2020. In addition, there are plans which include working with Associated Charities, the public, health professionals and policy makers to work with them in developing a strategy for wider community engagement.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/07/2017: Overall study end date was updated from 31/01/2020 to 31/05/2020. Recruitment dates were updated from 15/06/2018 - 31/01/2020 to 01/09/2017 - 29/02/2020.