Early Inflammatory Arthritis Clinical Trial
Official title:
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
Peer support (including informational, emotional, appraisal support) has been shown to help persons with chronic conditions. The goal of this research is to examine the impact of early peer support on the health and quality of life of individuals with early inflammatory arthritis (EIA). The investigators hypothesize that early peer support will result in improved use of disease modifying anti-rheumatic drug (DMARD) or biologic 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. In this study, persons with IA will be trained as peer mentors using a training program developed for a pilot study. Individuals with EIA will be randomized to receive either "peer support program" or "standard care". Peer mentors will be paired with a person with EIA to provide one-on-one support (face-to-face or telephone) once a week for approximately 30 minutes over a 12-week period. All "standard care" participants will receive the peer mentoring intervention at the end of study. Both groups will be evaluated using self-administered questionnaires and clinical assessments, and results of the two groups will be compared. This information will be used to design a larger study.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01347372 -
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training
|
N/A | |
| Completed |
NCT01054131 -
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
|
N/A | |
| Completed |
NCT01054963 -
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis - Peer Mentor Training
|
N/A | |
| Completed |
NCT00821730 -
Exploring the Learning Needs of Individuals With Inflammatory Arthritis From the Perspectives of Patients, Family Members and Friends, and Health Care Providers: Perspectives of Family Members and Friends
|
N/A |