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

Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556591
• Other study ID #: HUM00184455
• Secondary ID: UL1TR002240
• Status: Completed
• Phase: N/A
• 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
• 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 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)

Related Conditions & MeSH terms

• Caregivers

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