Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

Not Applicable

Completed

• Conditions: Caregivers
• Interventions: Behavioral: Control; Behavioral: Just-in-time adaptive intervention (JITAI)

• Registration Number: NCT04556591
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2020-11-05
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Results First Submitted: 2022-05-31
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Results First Posted: 2023-03-21
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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).
Just-in-time adaptive intervention (JITAI)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire	3 months of wearing the Fitbit and completing the surveys	Items are scaled from 1 to 5 to indicate the level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement".; Percentages shown are the combined percentage of participants who selected "agree" or "strongly agree" or their equivalent (as labeled).

Secondary Outcome Measures

Name	Time	Method
Attrition as Measured by the Percent of Participants Completing the Study	3 months of wearing the Fitbit and completing the surveys
Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study	3 months of wearing the Fitbit and completing the surveys	Contributed data percentages are shown by caregiver group (HD, SCI, HCT) for daily surveys, daily steps, daily sleep, calculated by number of days of data provided divided by number of total possible days that it could be provided.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States