Clinical trial NCT04570930: Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Official title: Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: Stress
Anxiety
Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-09-30
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This behavioral trial will use a 2-arm randomized controlled design.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
timeFrame: Baseline, Day 180 of intervention
Secondary outcomes:
measure: Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
timeFrame: Baseline, Day 180 of intervention
measure: Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
timeFrame: Baseline, Day 180 of intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Michigan
name: Noelle Carlozzi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.