Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT04570930
• Recruitment Status: Recruiting
• First Posted: September 30, 2020
• Last Update Posted: December 11, 2020
• Sponsor: University of Michigan
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Noelle E Carlozzi, University of Michigan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Caregivers	Behavioral: Just-in-time adaptive intervention (JITAI); Behavioral: Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This behavioral trial will use a 2-arm randomized controlled design.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
• Actual Study Start Date: December 9, 2020
• Estimated Primary Completion Date: May 2025
• Estimated Study Completion Date: November 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in self-reported caregiver strain as measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain [ Time Frame: Baseline, Day 180 of intervention ]
   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.

Secondary Outcome Measures :

1. Change from baseline in self-reported anxiety score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety [ Time Frame: Baseline, Day 180 of intervention ]
   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.
2. Change from baseline in self-reported depression score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [ Time Frame: Baseline, Day 180 of intervention ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Chris Graves; 734-764-0644; PMR-CODAlab@med.umich.edu

Locations

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Chris Graves 734-764-0644 PMR-CODAlab@med.umich.edu

Principal Investigator: Noelle Carlozzi, Ph.D.

United States, Texas

Baylor College of Medicine; Not yet recruiting

Houston, Texas, United States, 77030

Contact: Jay Bogaards 713-797-7102 jay.bogaards@memorialhermann.org

Principal Investigator: Angelle Sander, Ph.D.

Sponsors and Collaborators

University of Michigan

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Noelle Carlozzi, Ph.D.; University of Michigan

More Information

• Responsible Party: Noelle E Carlozzi, Associate Professor of Physical Medicine and Rehabilitation, University of Michigan
• ClinicalTrials.gov Identifier: NCT04570930
• Other Study ID Numbers: HUM00181282; 2R01NR013658 ( U.S. NIH Grant/Contract )
• First Posted: September 30, 2020
• Last Update Posted: December 11, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• Time Frame: The data will be available after the acceptance for publication of the main findings from the final dataset.
• Access Criteria: Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noelle E Carlozzi, University of Michigan:

Stress; Anxiety; Depression

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries