Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
NCT ID: NCT04556591
Last Updated: 2023-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2020-11-05
2021-06-07
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
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
Participants will wear the Fitbit® and provide daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback).
Control
Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period
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 three-month (90 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.
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 three-month (90 day) period
Eligibility Criteria
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Inclusion Criteria
* 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
* Care partners of persons with HD: Be caring for an adult (18 years or older) with a clinical diagnosis of HD
* Care partners of persons with SCI: Be caring for an adult (18 years or older) that is ≥1 post-injury and sustained a medically documented SCI at age 16 or older
* Care partners of persons with HCT: Be caring for an adult (18 years or older) who is receiving, has received or is scheduled to receive HCT
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
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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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Wang J, Wu Z, Choi SW, Sen S, Yan X, Miner JA, Sander AM, Lyden AK, Troost JP, Carlozzi NE. The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study. JMIR Form Res. 2023 Sep 14;7:e43099. doi: 10.2196/43099.
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, Choi SW, Wu Z, Troost JP, Lyden AK, Miner JA, Graves CM, Wang J, Yan X, Sen S. An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study. Rehabil Psychol. 2022 Nov;67(4):497-512. doi: 10.1037/rep0000472.
Carlozzi NE, Choi SW, Wu Z, Miner JA, Lyden AK, Graves C, Wang J, Sen S. An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Dec 9;10(12):e32842. doi: 10.2196/32842.
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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HUM00184455
Identifier Type: -
Identifier Source: org_study_id
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