Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Caregivers Clinical Trial

Official title:

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570930
• Other study ID #: HUM00181282
• Secondary ID: 2R01NR013658
• Status: Completed
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: August 19, 2023

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: August 19, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Caregivers

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in self-reported caregiver strain as measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain	TBI-CareQOL Caregiver Strain assesses perceived feelings of feeling overwhelmed, stressed and "beat-down" related to the care partner role. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more strain.	Baseline, Day 180 of intervention
Secondary	Change from baseline in self-reported anxiety score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety	PROMIS Anxiety assesses self-reported feelings of fear, anxiety and hyper-arousal. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more anxiety.	Baseline, Day 180 of intervention
Secondary	Change from baseline in self-reported depression score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression	PROMIS Depression assesses self-reported feelings of sadness and worthlessness. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more depression.	Baseline, Day 180 of intervention