N/A
N=257
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Caregivers
Bottom Line
View on ClinicalTrials.gov: NCT04570930 ↗Enrolled (actual)
257
Serious AEs
0.8%
Results posted
Sep 2024
Primary outcome: Primary: Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain — -1.09; 0.34 T Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Just-in-time adaptive intervention (JITAI) (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain |
-1.09; 0.34 | — |
| SECONDARY Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety |
-1.14; 0.60 | — |
| SECONDARY Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression |
-1.01; 0.61 | — |
Summary
Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.
Eligibility Criteria
Inclusion Criteria
- Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older
- Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: "On a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc."
- Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
- Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)
Exclusion Criteria
- Is a professional, paid caregiver (e.g., home health aide)
- Anything that would preclude safe or meaningful participation in the study
Data sourced from ClinicalTrials.gov (NCT04570930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.