Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training (P2P EIA RCT)
|ClinicalTrials.gov Identifier: NCT01347372|
Recruitment Status : Unknown
Verified August 2012 by Dr. Mary Bell, Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : May 4, 2011
Last Update Posted : August 30, 2012
|Condition or disease||Intervention/treatment|
|Early Inflammatory Arthritis||Behavioral: Peer Mentor Training|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||May 2013|
Behavioral: Peer Mentor Training
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347372
|Contact: Mary J Bell, MD, FRCPCemail@example.com|
|Contact: Paula Veinot, MHScfirstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Mary J Bell, MD, FRCPC 416.480.4580 email@example.com|
|Contact: Paula Veinot, MHSc firstname.lastname@example.org|
|Sub-Investigator: Joanna Sale, PhD|
|Sub-Investigator: Sydney Brooks, PhD|
|Sub-Investigator: Sharron Sandhu, MB BCh, MRCP|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 3L9|
|Principal Investigator: Edward Keystone, MD, FRCPC|
|Sub-Investigator: Deborah Weber, RN, CCRC|
|Principal Investigator:||Mary J Bell, MD, FRCPC||Sunnybrook Health Sciences Centre|