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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01054131
Other study ID # 420-2009
Secondary ID
Status Completed
Phase N/A
First received January 21, 2010
Last updated December 23, 2011
Start date January 2010
Est. completion date December 2011

Study information

Verified date December 2011
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Have EIA disease duration within 6-52 weeks

2. 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

3. Prescription of a DMARD/biologic by the treating rheumatologist

4. Ability to speak and understand English without the aid of a secondary support person; AND

5. Capability to provide informed consent.

Exclusion Criteria:

1. IA disease duration less than 6 weeks or greater than 1 year

2. Previous or ongoing DMARD or biologic treatment

3. Inability to speak or read grade 6 English; AND

4. Inability to provide informed consent

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
peer support
A quasi-experimental, before and after study design will obtain data for planning and implementing a larger-scale study. Exposures and outcomes will be measured at baseline, 3 months (immediate post 12-week program) and 6 months (3 months post-program). Ten individuals with EIA will be recruited by brief screening interviews to ensure they meet inclusion criteria. Each pair of peer mentor and EIA participant will meet at SHSC for an initial contact. EIA participants will receive informational, emotional and appraisal support from trained peer mentors by telephone or neutral private location at a time convenient for both parties, at least once a week for 12 weeks.

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Canadian Arthritis Network

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary DMARD adherence 0, 3, 6 months No
Secondary coping efficacy 0, 3 6 months No
Secondary self-management 0, 3, 6 months No
Secondary anxiety 0, 3, 6 months No
Secondary self efficacy 0, 3, 6 months No
Secondary social support 0, 3, 6 months No
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