Ontario Brain Injury Association (OBIA) Peer Support Program

NCT03450460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-09-25

No results posted yet for this study

Summary

Most people with moderate or severe TBI have difficulty returning to their usual social roles and activities. The OBIA has developed a program where peers (other individuals living with TBI) coach or mentor those with more recent brain injury. The objective of this project is to evaluate the feasibility of measuring the impact of the OBIA Peer Program on social participation and mood compared to a control group who have not received peer support yet.

The proposed study will involve three phases. It will begin with a qualitative component (stakeholder interviews), then a pilot RCT, and end with more interviews to explore the success of the study intervention. A qualitative descriptive approach will be used at these first and last phases of the study. In Phase 1, interviews will be conducted with approximately 15 participants including individuals with moderate to severe TBI, caregivers, Mentors, OBIA staff members, and health researchers. The proposed Phase 2 will be a clinical trial, conducted with 60 participants. These participants will be randomized to one of three groups: a twice a week Program (n=20), a once a week Program (n=20), or the wait list control group (n=20). For Phase 3, a sub group of approximately 25 participants from Phase 2 who participated in the OBIA Peer Support Program will be asked to participate in a one-on-one, telephone/Skype interview. A sub-group of Mentors will also be asked to participate in a one-on-one, telephone/Skype interview.

This research project will address the highest priority areas of "strategies to enhance social participation and community life (personal relationships)" and "psychological strategies to improve mood, depression, and irritability", as identified in the ONF's Request for Proposals on "Addressing Evidence Gaps in Moderate to Severe TBI Rehabilitation". The study will provide important results to inform a RCT (of appropriate size) on the impact of peer support on the social participation and mood of individuals with moderate to severe TBI. This study will then provide the best evidence to support the recommendation on "a peer-supported relationship model of intervention", and inform future versions of the INESSS-ONF Guideline.

Conditions

  • Acquired Brain Injury

Interventions

BEHAVIORAL

Peer support

The Program matches volunteer Mentors and Partners for a series of one-to-one interactions that focus on the discussion and resolution of problems or issues (i.e., problem solving) related to one or several key topic areas including family and friends, resources, life changes or challenges, (health care) professionals, social/recreational activities, work/employment/training/volunteering, the brain injury itself, emotions or feelings, and other issues.27 Once the match is established, the Mentor and Partner communicate with one another primarily by telephone until the problems or issues are either resolved or a referral to another service is made (i.e., counselling or community support services). For some partnerships, communication by email or video conferencing is used.27 Most telephone calls last between 20 and 40 minutes (personal communication) and are held weekly.

Sponsors & Collaborators

  • Ontario Neurotrauma Foundation

    collaborator OTHER
  • Ontario Brain Injury Association

    collaborator UNKNOWN
  • Toronto Rehabilitation Institute

    lead OTHER

Principal Investigators

  • Sarah Munce · Toronto Rehabilitation, University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2020-02-13
Completion
2020-06-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450460 on ClinicalTrials.gov