NCT01347372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

May 2, 2011

Last Update Submit

April 11, 2018

Conditions

Keywords

peer supportpeer mentoringpeer counsellingarthritischronic diseaseinflammatory arthritisearly inflammatory arthritisrheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 months (baseline); immediate post-training; immediate post peer mentoring intervention and 3 months follow-up post peer mentoring intervention

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years of age or older; and
  • Able to speak, understand, read and write English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

MeSH Terms

Conditions

ArthritisChronic DiseaseArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mary J Bell, MD, FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatologist

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations