NCT01347359

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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

Click on a node to explore related trials.

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

Early Inflammatory Arthritis

Keywords

Peer supportPeer mentoringPeer counsellingArthritisInflammatory arthritisEarly inflammatory arthritisRheumatoid arthritisChronic disease

Outcome Measures

Primary Outcomes (1)

  • 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

    0 months (baseline), immediate post-program, 3 months post-program

Secondary Outcomes (7)

  • Self-efficacy

    0 months (baseline), immediate post-program, 3 months post-program

  • Health-related quality of life

    0 months (baseline), immediate post-program, 3 months post-program

  • Anxiety

    0 months (baseline), immediate post-program, 3 months post-program

  • Coping-efficacy

    0 months (baseline), immediate post-program, 3 months post-program

  • Social support

    0 months (baseline), immediate post-program, 3 months post-program

  • +2 more secondary outcomes

Study Arms (2)

One-on-one peer support

EXPERIMENTAL

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

Control - Standard of care

ACTIVE COMPARATOR

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

Behavioral: Standard of care

Interventions

One-on-one peer supportBEHAVIORAL

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.

One-on-one peer support
Standard of careBEHAVIORAL

"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).

Control - Standard of care

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of osteoarthritis, Systemic lupus erythematosus, DM neuropathy or trauma

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

ArthritisArthritis, RheumatoidChronic Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mary J Bell, MD, FRCPC

    Division of Reumatology, Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
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

CA(2)