Clinical trial NCT04556591: Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
Official title: Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: Depression
Insomnia
Stress related disorders
Anxiety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-09-21
Enrollment: 72
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 two-arm randomized controlled design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.


Eligibility criteria: Care Partner Inclusion Criteria:

* Provide emotional, physical, and/or financial support/assistance to an individual with spinal cord injury (SCI), Huntington's Disease (HD), or hematopoietic cell transplantation (HCT)
* 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:

* Is a professional, paid caregiver (e.g., home health aide)

Primary outcomes:
measure: Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
timeFrame: 3 months of wearing the Fitbit and completing the surveys
Secondary outcomes:
measure: Attrition as Measured by the Percent of Participants Completing the Study
timeFrame: 3 months of wearing the Fitbit and completing the surveys
measure: Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study
timeFrame: 3 months of wearing the Fitbit and completing the surveys
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Noelle Carlozzi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.