- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054131
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
December 23, 2011 updated by: Dr. Mary Bell, Sunnybrook Health Sciences Centre
Inflammatory arthritis (IA) is a major cause of long-term disability.
Peer support may be a solution to the common problem of delayed treatment.
Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis.
The whole intervention study comprises of two parts: The first part involves the development and testing of a peer mentor training initiative, which is called "Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentor Training".
The second part, which is the focus of this study, involves the delivery of a one-on-one peer support intervention from a trained peer mentor to an individual newly diagnosed with EIA.
The feasibility and acceptability of the program will be determined, as well as the health outcomes following the participation of the program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have EIA disease duration within 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
- Prescription of a DMARD/biologic by the treating rheumatologist
- Ability to speak and understand English without the aid of a secondary support person; AND
- Capability to provide informed consent.
Exclusion Criteria:
- IA disease duration less than 6 weeks or greater than 1 year
- Previous or ongoing DMARD or biologic treatment
- Inability to speak or read grade 6 English; AND
- Inability to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
DMARD adherence
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
coping efficacy
Time Frame: 0, 3 6 months
|
0, 3 6 months
|
|
self-management
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
anxiety
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
self efficacy
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
|
social support
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mary J Bell, MD, FRCPC, Rheumatologist, Sunnybrook Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 21, 2010
First Submitted That Met QC Criteria
January 21, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Estimate)
December 29, 2011
Last Update Submitted That Met QC Criteria
December 23, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 420-2009
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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