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OpenTrials
Completed

NCT Number: NCT04556591

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

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.

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Key information

Conditions

Caregivers Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Just-in-time adaptive intervention (JITAI)

Behavioral

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

Behavioral

Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period

Primary outcomes

  1. Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire

    Time frame: 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 outcomes

  1. Attrition as Measured by the Percent of Participants Completing the Study

    Time frame: 3 months of wearing the Fitbit and completing the surveys

  2. Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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