Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

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 Overview

• Status: Completed
• Conditions: Caregivers
• Intervention / Treatment: Behavioral: Just-in-time adaptive intervention (JITAI); Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Just-in-time adaptive intervention (JITAI); Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.	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.
Active Comparator: Control; Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).	Behavioral: Control; Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Noelle Carlozzi, Ph.D., University of Michigan

Publications and helpful links

General Publications

• Carlozzi NE, Sander AM, Choi SW, Wu Z, Miner JA, Lyden AK, Graves C, Sen S. Improving outcomes for care partners of persons with traumatic brain injury: Protocol for a randomized control trial of a just-in-time-adaptive self-management intervention. PLoS One. 2022 Jun 9;17(6):e0268726. doi: 10.1371/journal.pone.0268726. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): August 19, 2023
• Study Completion (Actual): August 19, 2023

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HUM00181282; 2R01NR013658 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan Project Manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.
• IPD Sharing Time Frame: The data will be available after the acceptance for publication of the main findings from the final dataset.
• IPD Sharing Access Criteria: Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No