Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
NCT ID: NCT04570930
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
257 participants
INTERVENTIONAL
2020-12-09
2023-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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 (without the personalized feedback).
Control
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Anything that would preclude safe or meaningful participation in the study
18 Years
ALL
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Michigan
OTHER
Responsible Party
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Noelle E Carlozzi
Associate Professor of Physical Medicine and Rehabilitation
Principal Investigators
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Noelle Carlozzi, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Carlozzi NE, Choi SW, Wu Z, Sen S, Troost J, Lyden AK, Miner JA, Graves C, Sander AM. The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups. J Patient Rep Outcomes. 2023 Jun 26;7(1):57. doi: 10.1186/s41687-023-00602-x.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00181282
Identifier Type: -
Identifier Source: org_study_id
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