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| Name | Class |
|---|---|
| American Occupational Therapy Foundation | OTHER |
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This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENGAGE-TBI | Experimental | The outcome measures for feasibility will be participant satisfaction (Client Satisfaction Questionnaire-8), intervention fidelity, engagement in intervention (Pittsburgh Rehabilitation Participation Scale), attendance rate, and retention rate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social intervention study for TBI survivors | Behavioral | ENGAGE-TBI is a community-based group intervention that is co-facilitated by an occupational therapist and a person with a brain injury. ENGAGE-TBI incorporates social learning, guided problem-solving, and skilled practice of strategies to achieve social participation goals. It is delivered in 12 90-minute group sessions that are held twice per week for 6 weeks. Aside from community outings, sessions will take place at the Brain Injury Association of Missouri on a separate day and time from education group sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire-8 | 8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction | Post-Treatment (6-weeks) |
| Pittsburgh Rehabilitation Participation Scale | Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation. | Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation) |
| PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities | Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation) | Baseline, Post-Treatment (6-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation | Computer Adaptive Test examining social isolation; scores reported as T-scores (0-100 scale, higher scores indicate higher isolation) | Baseline, Post-Treatment (6-weeks) |
| PROMIS-29 (Patient-Reported Outcome Measures Information System) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L | Contact | +1 314 273 7540 | jkersey@wustl.edu | |
| Curtis Comer, Clinical Research Coordinator I, High School | Contact | +1 314 273 3288 | curtisccomer@wustl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
This study will produce feasibility data and clinical outcome data on 30 participants with brain injury. De-identified data will be shared for all patient-reported outcome measures: Client Satisfaction Questionnaire-8, PROMIS Ability to Participate in Social Roles and Activities, PROMIS Social Isolation, and PROMIS-29. Raw data will be transformed to T-scores on the PROMIS measures, and T-scores will be used on the shared dataset.
Data will be made available six months after the end of the grant period and will be made available for a minimum of 10 years.
The dataset and data dictionary will be disseminated via the Washington University Research Data Repository, which is publicly available. Controlled access will not be used. The data that are shared will be shared by unrestricted download.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores (0-100 scale, lower scores indicate greater health) |
| Baseline, Post-Treatment (6-weeks) |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |