Ontario Brain Injury Association (OBIA) Peer Support Program

NCT03450460 | Completed DMC

• 1 other identifier: TorontoRI
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peer support; feasibility trial; mixed methods

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Participation at 4 months

  Community Integration Questionnaire (CIQ)

  Baseline to 4 months

Secondary Outcomes (3)

• Change from Baseline Mood at 4 months

  Baseline to 4 months

• Change from Health-related Quality of Life at 4 months

  Baseline to 4 months

• Change from Self-efficacy at 4 months

  Baseline to 4 months

Study Arms (2)

1/week peer support

EXPERIMENTAL

These individuals with acquired brain injury will receive the Ontario Brain Injury Association Peer Support program once per week.

Behavioral: Peer support

wait list control group

NO INTERVENTION

These individuals with acquired brain injury will receive the Ontario Brain Injury Association Peer Support once the trial period is complete.

Interventions

Peer support BEHAVIORAL

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.

1/week peer support

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partner participants, including caregiver Partners,
• Community-based (i.e., no longer participating in a comprehensive rehabilitation program) individuals;
• Have a moderate to severe TBI (Glasgow Coma Scale ≤12) or have cared for (i.e., unpaid) an individual with moderate to severe TBI for at least one year;
• Are 18 years of age or older;
• Have participated in the OBIA Peer Support Program;
• Are fluent in English; and,
• Are able to provide informed consent/have an available proxy who is able to provide informed consent.
• Mentor participants -Completed at least one partnership with the OBIA Peer Support Program

You may not qualify if:

• Partner participants, including caregiver Partners,
• Individuals who are medically unstable or have active suicidal ideation
• For Phase 2 and 3
• Partner/Mentor participants
• Community-based (i.e., no longer participating in a comprehensive rehabilitation program);
• Have a moderate to severe TBI (Glasgow Coma Scale of 12 or less);
• Are 18 years of age or older;
• Are fluent in English; and,
• Are able to provide informed consent/have an available proxy who is able to provide informed consent.
• Note that Mentor participants may include newly-trained Mentors or Mentors that have already had previous mentorship experience with the OBIA Peer Support Program.
• Previously participated in the OBIA Peer Support Program or currently receiving peer support/self-management program elsewhere;
• Are medically unstable; and,
• Have active suicidal ideation

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Ontario Neurotrauma Foundation: collaborator
• Ontario Brain Injury Association: collaborator

Study Sites (1)

Ontario Brain Injury Association

Toronto, Ontario, Canada

Location

Related Publications (1)

• Munce SEP, Jaglal S, Kastner M, Nelson MLA, Salbach NM, Shepherd J, Sweet SN, Wilcock R, Thoms C, Bayley MT. Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial. BMJ Open. 2019 Mar 23;9(3):e023367. doi: 10.1136/bmjopen-2018-023367.

  PMID: 30904839 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah Munce

  Toronto Rehabilitation, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 1, 2018
• Study Start: May 16, 2018
• Primary Completion: February 13, 2020
• Study Completion: June 18, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)