NCT01054131

Brief Summary

Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. The whole intervention study comprises of two parts: The first part involves the development and testing of a peer mentor training initiative, which is called "Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentor Training". The second part, which is the focus of this study, involves the delivery of a one-on-one peer support intervention from a trained peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of the program will be determined, as well as the health outcomes following the participation of the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

1.7 years

First QC Date

January 21, 2010

Last Update Submit

December 23, 2011

Conditions

Keywords

peer supportpeer mentorself-managementearly inflammatory arthritischronic disease

Outcome Measures

Primary Outcomes (1)

  • DMARD adherence

    0, 3, 6 months

Secondary Outcomes (5)

  • coping efficacy

    0, 3 6 months

  • self-management

    0, 3, 6 months

  • anxiety

    0, 3, 6 months

  • self efficacy

    0, 3, 6 months

  • social support

    0, 3, 6 months

Interventions

peer supportBEHAVIORAL

A quasi-experimental, before and after study design will obtain data for planning and implementing a larger-scale study. Exposures and outcomes will be measured at baseline, 3 months (immediate post 12-week program) and 6 months (3 months post-program). Ten individuals with EIA will be recruited by brief screening interviews to ensure they meet inclusion criteria. Each pair of peer mentor and EIA participant will meet at SHSC for an initial contact. EIA participants will receive informational, emotional and appraisal support from trained peer mentors by telephone or neutral private location at a time convenient for both parties, at least once a week for 12 weeks.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have EIA disease duration within 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
  • Prescription of a DMARD/biologic by the treating rheumatologist
  • Ability to speak and understand English without the aid of a secondary support person; AND
  • Capability to provide informed consent.

You may not qualify if:

  • IA disease duration less than 6 weeks or greater than 1 year
  • Previous or ongoing DMARD or biologic treatment
  • Inability to speak or read grade 6 English; AND
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Sandhu S, Veinot P, Embuldeniya G, Brooks S, Sale J, Huang S, Zhao A, Richards D, Bell MJ. Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. BMJ Open. 2013 Mar 1;3(3):e002267. doi: 10.1136/bmjopen-2012-002267.

MeSH Terms

Conditions

ArthritisChronic Disease

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary J Bell, MD, FRCPC

    Rheumatologist, Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations