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Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training (P2P EIA RCT)

Primary Purpose

Early Inflammatory Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Peer Mentor Training
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Early Inflammatory Arthritis focused on measuring peer support, peer mentoring, peer counselling, arthritis, chronic disease, inflammatory arthritis, early inflammatory arthritis, rheumatoid arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of IA from a physician;
  • Disease duration at least 2 years and managing well;
  • Currently using medications (DMARDS/biologics) to treat his/her arthritis
  • Completion of Arthritis Self-Management Program (ASMP) provided by The Arthritis Society and/or similar program and/or have sufficient knowledge and experience with teaching or providing mentoring support to an individual living with a chronic disease;
  • Able to attend a series of training sessions (approximately 20 hours in total);
  • Able to take part in ongoing assessment/evaluation activities (self-report questionnaire; interviews, observation; study activity log)
  • Able to commit to the duration of the research study (9 -12 months);
  • Willing to provide ongoing one-on-one support to an individual newly diagnosed with IA;
  • 18 years of age or older; and
  • Able to speak, understand, read and write English.

Exclusion Criteria:

Sites / Locations

  • Sunnybrook Health Sciences Centre
  • Mount Sinai Hospital

Outcomes

Primary Outcome Measures

self-efficacy
The primary goals of this study are to increase peer mentors' knowledge, confidence, skills and abilities to provide one-on-one support to individuals with EIA. It is anticipated that after training, peer mentors will be able to provide support to help persons with EIA to make informed decisions to self-manage their disease.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2011
Last Updated
April 11, 2018
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Rheumatology Association, The Arthritis Society, Canada, Mount Sinai Hospital, Canada, Unity Health Toronto, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01347372
Brief Title
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training
Acronym
P2P EIA RCT
Official Title
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Rheumatology Association, The Arthritis Society, Canada, Mount Sinai Hospital, Canada, Unity Health Toronto, University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Inflammatory Arthritis
Keywords
peer support, peer mentoring, peer counselling, arthritis, chronic disease, inflammatory arthritis, early inflammatory arthritis, rheumatoid arthritis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Peer Mentor Training
Intervention Description
Peer mentors will complete a training program (up to 20 hours) during which they will be evaluated. This face-to-face training applies an interactive format, with a combination of lectures, question/answer sessions, and experiential learning (e.g. role-playing, simulations) and practice sessions.
Primary Outcome Measure Information:
Title
self-efficacy
Description
The primary goals of this study are to increase peer mentors' knowledge, confidence, skills and abilities to provide one-on-one support to individuals with EIA. It is anticipated that after training, peer mentors will be able to provide support to help persons with EIA to make informed decisions to self-manage their disease.
Time Frame
0 months (baseline); immediate post-training; immediate post peer mentoring intervention and 3 months follow-up post peer mentoring intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of IA from a physician; Disease duration at least 2 years and managing well; Currently using medications (DMARDS/biologics) to treat his/her arthritis Completion of Arthritis Self-Management Program (ASMP) provided by The Arthritis Society and/or similar program and/or have sufficient knowledge and experience with teaching or providing mentoring support to an individual living with a chronic disease; Able to attend a series of training sessions (approximately 20 hours in total); Able to take part in ongoing assessment/evaluation activities (self-report questionnaire; interviews, observation; study activity log) Able to commit to the duration of the research study (9 -12 months); Willing to provide ongoing one-on-one support to an individual newly diagnosed with IA; 18 years of age or older; and Able to speak, understand, read and write English. Exclusion Criteria: •
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J Bell, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentor Training

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