Clinical trial NCT01347359: Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
Official title: Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Inflammatory Arthritis
Keywords: Peer support
Peer mentoring
Peer counselling
Arthritis
Inflammatory arthritis
Early inflammatory arthritis
Rheumatoid arthritis
Chronic disease
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Rheumatology Association
name: Mount Sinai Hospital, Canada
name: The Arthritis Society, Canada
name: Unity Health Toronto
name: University of Toronto
First posted: 2011-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* EIA disease (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) duration 6 - 52 weeks
* At least 3 swollen joints, assessed by the treating rheumatologist, OR Positive compression test for the metacarpophalangeal joints, OR Positive compression test for the metatarsophalangeal joints, OR At least 30 minutes of morning stiffness (Lineker et al., 1999)
* Prescription of a DMARD/biologic by the treating rheumatologist
* Ability to speak, understand, read and write English without the aid of a secondary support person
* Ability to provide informed consent

Exclusion Criteria:

• Diagnosis of osteoarthritis, Systemic lupus erythematosus, DM neuropathy or trauma

Primary outcomes:
measure: Use of orally administered DMARD or biologic treatment
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
Secondary outcomes:
measure: Self-efficacy
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Health-related quality of life
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Anxiety
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Coping-efficacy
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Social support
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Self-management
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
measure: Disease activity
timeFrame: 0 months (baseline), immediate post-program, 3 months post-program
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Division of Reumatology, Sunnybrook Health Sciences Centre
name: Mary J Bell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: