- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347359
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program (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 (Anticipated)
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One-on-one peer support
The peer support intervention will take the form of a one-on-one peer mentoring program, either face-to-face or by telephone.
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The peer support intervention will take the form of a one-on-one peer mentoring program, using a mutually agreed upon method of communication between each pair of peer mentor and EIA participant (either by telephone or face-to-face meeting at a neutral public location).
The research team will pair trained peer mentors and individuals with EIA as closely as possible based on such characteristics as sex, age, working status, and specific disease/type of IA.
Peer mentors will be responsible to initiate and maintain contact with individuals with EIA.
Individuals with EIA and peer mentors will be asked to have contact once a week for 30 minutes during the 12-week study period.
Meetings/ interactions will not be prescribed; rather they will be defined by the individual with EIA.
Peer mentors will provide support based on the needs of the individual they are mentoring.
As such the nature of each interaction is likely to vary among pairs and from one interaction to the next.
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Active Comparator: Control - Standard of care
"Standard of care" is at the discretion of the treating rheumatologist.
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"Standard of care" is at the discretion of the treating rheumatologist.
In addition to information and patient education about the underlying disease process provided at the time of diagnosis, it may include referral to allied health professionals (e.g., physiotherapist, occupational therapist, podiatrist, social worker).
This may be via referral to The Arthritis Society or directly to individual practitioners.
In addition, it may include referral to voluntary support programs in the community (e.g., Arthritis Self-Management Program).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of orally administered DMARD or biologic treatment
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Use of orally administered DMARD or biologic treatment in individuals with EIA as determined indirectly through the modified Morisky scale for medication adherence
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0 months (baseline), immediate post-program, 3 months post-program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Self-efficacy using Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES)
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0 months (baseline), immediate post-program, 3 months post-program
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Health-related quality of life
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Health-related quality of life as measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2
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0 months (baseline), immediate post-program, 3 months post-program
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Anxiety
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Anxiety is measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2), dimension sub score for anxiety
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0 months (baseline), immediate post-program, 3 months post-program
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Coping-efficacy
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Coping-efficacy as assessed using a measure developed by Gignac et al. (2000)
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0 months (baseline), immediate post-program, 3 months post-program
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Social support
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Social support as measured by Medical Outcomes Study Social Support Survey (MOSSS)
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0 months (baseline), immediate post-program, 3 months post-program
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Self-management
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Self-management as evaluated using Patient Activation Measure (PAM) to measure the knowledge, skills, and confidence aspects of self management
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0 months (baseline), immediate post-program, 3 months post-program
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Disease activity
Time Frame: 0 months (baseline), immediate post-program, 3 months post-program
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Disease activity as assessed using the Clinical Disease Activity Index (CDAI): A rheumatologist from the research team will conduct clinical assessments for CDAI score, which is a propensity score for disease activity in rheumatoid arthritis.
It accounts for upper extremity tender and swollen joints, and patient and evaluator impressions of disease progression
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0 months (baseline), immediate post-program, 3 months post-program
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary J Bell, MD, FRCPC, Division of Reumatology, 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
- 094-2011
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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