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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Rheumatology Association
Mount Sinai Hospital, Canada
The Arthritis Society, Canada
St. Michael's Hospital, Toronto
University of Toronto
Information provided by (Responsible Party):
Dr. Mary Bell, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01347359
First received: May 2, 2011
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Early Inflammatory Arthritis
Behavioral: One-on-one peer support
Behavioral: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Use of orally administered DMARD or biologic treatment [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Self-efficacy using Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES)

  • Health-related quality of life [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Health-related quality of life as measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2

  • Anxiety [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Anxiety is measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2), dimension sub score for anxiety

  • Coping-efficacy [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Coping-efficacy as assessed using a measure developed by Gignac et al. (2000)

  • Social support [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Social support as measured by Medical Outcomes Study Social Support Survey (MOSSS)

  • Self-management [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    Self-management as evaluated using Patient Activation Measure (PAM) to measure the knowledge, skills, and confidence aspects of self management

  • Disease activity [ Time Frame: 0 months (baseline), immediate post-program, 3 months post-program ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: One-on-one peer support
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.
Active Comparator: Control - Standard of care
"Standard of care" is at the discretion of the treating rheumatologist.
Behavioral: Standard of care
"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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347359

Contacts
Contact: Mary J Bell, MD, FRCPC 416-480-4580 mary.bell@sunnybrook.ca
Contact: Paula Veinot, MHSc veinotpayne@sympatico.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Mary J Bell, MD, FRCPC    416-480-4580    mary.bell@sunnybrook.ca   
Contact: Paula Veinot, MHSc       veinotpayne@sympatico.ca   
Sub-Investigator: Joanna Sale, PhD         
Sub-Investigator: Sydney Brooks, PhD         
Sub-Investigator: Sharron Sandhu, MB BCh, MRCP         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Principal Investigator: Edward Keystone, MD, FRCPC         
Sub-Investigator: Deborah Weber, RN, CCRC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Rheumatology Association
Mount Sinai Hospital, Canada
The Arthritis Society, Canada
St. Michael's Hospital, Toronto
University of Toronto
Investigators
Principal Investigator: Mary J Bell, MD, FRCPC Division of Reumatology, Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Mary Bell, Rheumatologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01347359     History of Changes
Other Study ID Numbers: 094-2011
Study First Received: May 2, 2011
Last Updated: August 29, 2012
Health Authority: Canada: Research Ethics Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Peer support
Peer mentoring
Peer counselling
Arthritis
Inflammatory arthritis
Early inflammatory arthritis
Rheumatoid arthritis
Chronic disease

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 20, 2014