A Randomized Controlled Feasibility Trial on the Ontario Brain Injury Association Peer Support Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from Baseline Participation at 4 months
研究概览
简要总结
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.
详细描述
Phase 1 - Understanding the Enablers, Barriers of Implementing the Trial Protocol
Specific Objective: To understand the perceived enablers and barriers of implementing the peer support trial protocol, including the perceived enablers and barriers to participant recruitment, retention, adherence, and data collection, of implementing the selected outcomes measures, and of participating in the trial, from the perspective of stakeholders (knowledge users) including individuals with moderate to severe TBI, caregivers, OBIA Peer Support Program Mentors, OBIA staff members who are a part of the Peer Support Program, health services and knowledge translation (KT) researchers with expertise in TBI, and methodologists with expertise in clinical trials; Hypothesis: A better understanding of the perceived enablers and barriers of implementing the peer support trial protocol will enhance the effectiveness of the intervention and feasibility of the trial in Phase 2 and results will be used to refine the research protocol for the RCT, if necessary.
Participants and recruitment: A purposive sampling of each of the different stakeholder groups will be used. The OBIA Peer Support Program Database will be used to recruit the Partners (including caregivers) and Mentors. On-line searches and/or the contacts of the Principal Investigators will be used to recruit the OBIA staff members and the researchers/methodologists. We will aim to recruit a total of 15 key informants for Phase 1. Individuals who are interested in participating in the study will contact the Research Coordinator via telephone or email to gain further information about the study. The eligibility criteria of all participants will be confirmed by the Research Coordinator. This process will be followed for all phases of the study.
Data collection: participants will take part in a one-on-one, semi-structured telephone/Skype interview lasting approximately 45-60 minutes. All interviews will be digitally recorded and transcribed verbatim for data analysis. During transcription, any identifying information will be removed and the participant will be assigned a coded identifier.
Data analysis: analysis will be conducted using inductive thematic analysis as described by Braun and Clark (2006). The analysis will assess the perceived enablers and barriers to participant recruitment, retention, adherence, and data collection, of implementing the selected outcomes measures, and of participating in the OBIA Peer Support Program and the trial itself. To facilitate the organization and analysis of the qualitative data, the Principal Investigator's/Research Coordinator's reflective notes from the interviews, as well as the transcripts, will be entered into NVivo v.11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Phase 1
- •Inclusion Criteria
- •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
排除标准
- •Partner participants, including caregiver Partners,
- •Individuals who are medically unstable or have active suicidal ideation
- •For Phase 2 and 3
- •Inclusion Criteria
- •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.
- •Exclusion Criteria
- •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
研究组 & 干预措施
1/week peer support
These individuals with acquired brain injury will receive the Ontario Brain Injury Association Peer Support program once per week.
干预措施: Peer support (Behavioral)
wait list control group
These individuals with acquired brain injury will receive the Ontario Brain Injury Association Peer Support once the trial period is complete.
结局指标
主要结局
Change from Baseline Participation at 4 months
时间窗: Baseline to 4 months
Community Integration Questionnaire (CIQ)
次要结局
- 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)
- Change from Baseline Mood at 4 months(Baseline to 4 months)
研究者
Sarah Munce
Scientist
University Health Network, Toronto