CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 257 enrolled
Drug / intervention
Just-in-time adaptive intervention (JITAI) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04570930
NCT04570930N/ACompleted
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Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

University of Michigan·interventional·Posted Sep 30, 2020·Updated Sep 19, 2024

In Brief

A clinical study evaluating Just-in-time adaptive intervention (JITAI) and Control for Caregivers. Completed, enrolled 257 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaregivers
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 30, 2020
Enrollment StartDec 9, 2020
Primary CompletionAug 19, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.8 years ago

Interventions

Just-in-time adaptive intervention (JITAI)behavioral

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.

Controlbehavioral

Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.