Trials / Completed
CompletedNCT04570930
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 257 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Just-in-time adaptive intervention (JITAI) | JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert. |
| BEHAVIORAL | Control | Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period. |
Timeline
- Start date
- 2020-12-09
- Primary completion
- 2023-08-19
- Completion
- 2023-08-19
- First posted
- 2020-09-30
- Last updated
- 2024-09-19
- Results posted
- 2024-09-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04570930. Inclusion in this directory is not an endorsement.