search
Back to results

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

Primary Purpose

Early Inflammatory Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
One-on-one peer support
Standard of care
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
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, Inflammatory arthritis, Early inflammatory arthritis, Rheumatoid arthritis, Chronic disease

Eligibility Criteria

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

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

Sites / Locations

  • Sunnybrook Health Sciences Centre
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One-on-one peer support

Control - Standard of care

Arm Description

The peer support intervention will take the form of a one-on-one peer mentoring program, either face-to-face or by telephone.

"Standard of care" is at the discretion of the treating rheumatologist.

Outcomes

Primary Outcome Measures

Use of orally administered DMARD or biologic treatment
Use of orally administered DMARD or biologic treatment in individuals with EIA as determined indirectly through the modified Morisky scale for medication adherence

Secondary Outcome Measures

Self-efficacy
Self-efficacy using Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES)
Health-related quality of life
Health-related quality of life as measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2
Anxiety
Anxiety is measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2), dimension sub score for anxiety
Coping-efficacy
Coping-efficacy as assessed using a measure developed by Gignac et al. (2000)
Social support
Social support as measured by Medical Outcomes Study Social Support Survey (MOSSS)
Self-management
Self-management as evaluated using Patient Activation Measure (PAM) to measure the knowledge, skills, and confidence aspects of self management
Disease activity
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

Full Information

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

1. Study Identification

Unique Protocol Identification Number
NCT01347359
Brief Title
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
Acronym
P2P EIA RCT
Official Title
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
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, Mount Sinai Hospital, Canada, The Arthritis Society, 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 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.

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, Inflammatory arthritis, Early inflammatory arthritis, Rheumatoid arthritis, Chronic disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One-on-one peer support
Arm Type
Experimental
Arm Description
The peer support intervention will take the form of a one-on-one peer mentoring program, either face-to-face or by telephone.
Arm Title
Control - Standard of care
Arm Type
Active Comparator
Arm Description
"Standard of care" is at the discretion of the treating rheumatologist.
Intervention Type
Behavioral
Intervention Name(s)
One-on-one peer support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
"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).
Primary Outcome Measure Information:
Title
Use of orally administered DMARD or biologic treatment
Description
Use of orally administered DMARD or biologic treatment in individuals with EIA as determined indirectly through the modified Morisky scale for medication adherence
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
Self-efficacy using Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES)
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Health-related quality of life
Description
Health-related quality of life as measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Anxiety
Description
Anxiety is measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2), dimension sub score for anxiety
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Coping-efficacy
Description
Coping-efficacy as assessed using a measure developed by Gignac et al. (2000)
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Social support
Description
Social support as measured by Medical Outcomes Study Social Support Survey (MOSSS)
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Self-management
Description
Self-management as evaluated using Patient Activation Measure (PAM) to measure the knowledge, skills, and confidence aspects of self management
Time Frame
0 months (baseline), immediate post-program, 3 months post-program
Title
Disease activity
Description
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
Time Frame
0 months (baseline), immediate post-program, 3 months post-program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J Bell, MD, FRCPC
Organizational Affiliation
Division of Reumatology, 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 Mentoring Program

We'll reach out to this number within 24 hrs