- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347372
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training (P2P EIA RCT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The investigators are proposing to examine the effectiveness of a peer support program, the aim of which is to assist individuals with early inflammatory arthritis (EIA) to receive the education and support they need to make decisions to manage their disease. Peer support (including informational, emotional, appraisal support) has been shown to assist persons with chronic conditions and may address challenges with receiving timely and proper treatment in persons with EIA.
Purpose: The goal of this pilot randomized controlled trial (RCT) is to evaluate the effectiveness of peer support to improve the health and quality of life of individuals with EIA. The investigators hypothesize that early peer support will result in improved use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, self-management, and disease activity score, as well as reduced anxiety for individuals with EIA within two years of their diagnosis.
Methods: This proposal builds on a pilot study, currently underway, to develop and evaluate the acceptability and feasibility of a peer support intervention for persons with EIA. The proposed effectiveness study will employ a RCT design with a wait list control group. Individuals with IA (diagnosis 2 or more years) will be trained as peer mentors using the revised pilot study training program. Peer mentors will be matched with a person newly diagnosed with IA to provide one-on-one support (face-to-face or telephone) over a 12-week period. Individuals with EIA will be recruited from rheumatology clinics at Sunnybrook Health Sciences Centre and Mount Sinai Hospital. Individuals with EIA will be randomized to either "intervention" or "standard care" (wait list). All "standard care" participants with EIA will receive the peer mentoring program at the end of study period; their outcomes will be also be evaluated. Both "intervention" and "standard care" participants will complete clinical assessments and self-administered questionnaires before and after (immediate post-program and 3-month follow-up) study completion to evaluate use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, anxiety, self-management, and disease activity count.
Implication: The study aims to improve the education and support for patients with EIA. The data from this study will be used to further refine the intervention and study design to be subsequently submitted for further effectiveness testing in a larger scale RCT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5T 3L9
- Mount Sinai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of IA from a physician;
- Disease duration at least 2 years and managing well;
- Currently using medications (DMARDS/biologics) to treat his/her arthritis
- Completion of Arthritis Self-Management Program (ASMP) provided by The Arthritis Society and/or similar program and/or have sufficient knowledge and experience with teaching or providing mentoring support to an individual living with a chronic disease;
- Able to attend a series of training sessions (approximately 20 hours in total);
- Able to take part in ongoing assessment/evaluation activities (self-report questionnaire; interviews, observation; study activity log)
- Able to commit to the duration of the research study (9 -12 months);
- Willing to provide ongoing one-on-one support to an individual newly diagnosed with IA;
- 18 years of age or older; and
- Able to speak, understand, read and write English.
Exclusion Criteria:
•
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-efficacy
Time Frame: 0 months (baseline); immediate post-training; immediate post peer mentoring intervention and 3 months follow-up post peer mentoring intervention
|
The primary goals of this study are to increase peer mentors' knowledge, confidence, skills and abilities to provide one-on-one support to individuals with EIA.
It is anticipated that after training, peer mentors will be able to provide support to help persons with EIA to make informed decisions to self-manage their disease.
|
0 months (baseline); immediate post-training; immediate post peer mentoring intervention and 3 months follow-up post peer mentoring intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary J Bell, MD, FRCPC, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 095-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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