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Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program

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ClinicalTrials.gov Identifier: NCT01054131
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : December 29, 2011
Sponsor:
Collaborator:
Canadian Arthritis Network
Information provided by (Responsible Party):
Dr. Mary Bell, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE January 21, 2010
First Posted Date  ICMJE January 22, 2010
Last Update Posted Date December 29, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
DMARD adherence [ Time Frame: 0, 3, 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • coping efficacy [ Time Frame: 0, 3 6 months ]
  • self-management [ Time Frame: 0, 3, 6 months ]
  • anxiety [ Time Frame: 0, 3, 6 months ]
  • self efficacy [ Time Frame: 0, 3, 6 months ]
  • social support [ Time Frame: 0, 3, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
Official Title  ICMJE Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Condition  ICMJE
  • Early Inflammatory Arthritis
  • Chronic Disease
Intervention  ICMJE Behavioral: peer support
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.
Study Arms  ICMJE Not Provided
Publications * 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). pii: e002267. doi: 10.1136/bmjopen-2012-002267.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 21, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have EIA disease duration within 6-52 weeks
  2. 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
  3. Prescription of a DMARD/biologic by the treating rheumatologist
  4. Ability to speak and understand English without the aid of a secondary support person; AND
  5. Capability to provide informed consent.

Exclusion Criteria:

  1. IA disease duration less than 6 weeks or greater than 1 year
  2. Previous or ongoing DMARD or biologic treatment
  3. Inability to speak or read grade 6 English; AND
  4. Inability to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054131
Other Study ID Numbers  ICMJE 420-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Mary Bell, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Canadian Arthritis Network
Investigators  ICMJE
Principal Investigator: Mary J Bell, MD, FRCPC Rheumatologist, Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP