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Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

NCT04570930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2024-09-19

Study results available
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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

  • Caregivers

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Noelle Carlozzi, Ph.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2023-08-19
Completion
2023-08-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570930 on ClinicalTrials.gov