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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556591
Other study ID # HUM00184455
Secondary ID UL1TR002240
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date June 7, 2021

Study information

Verified date February 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 7, 2021
Est. primary completion date June 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 FitbitĀ® 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
United States The University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire 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).
3 months of wearing the Fitbit and completing the surveys
Secondary Attrition as Measured by the Percent of Participants Completing the Study 3 months of wearing the Fitbit and completing the surveys
Secondary Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study 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. 3 months of wearing the Fitbit and completing the surveys
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