Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347359
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2011-05-02
Brief Title:
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis An Effectiveness Study Pilot RCT- Peer Mentoring Program
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis An Effectiveness Study Pilot RCT- Peer Mentoring Program
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P2P EIA RCT
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None