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

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT04556591

Collaborator

(none)

Enrollment

Location

Arms

7.6

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers	Behavioral: Just-in-time adaptive intervention (JITAI) Behavioral: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This behavioral trial will use a two-arm randomized controlled design.This behavioral trial will use a two-arm randomized controlled design.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 5, 2020

Actual Primary Completion Date :

Jun 7, 2021

Actual Study Completion Date :

Jun 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Behavioral: Control Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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).

Behavioral: Control

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility and Acceptability as measured by the responses on the individual items on the Feasibility Questionnaire [End of enrollment, approximately 100 days]
Items are scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement"

Secondary Outcome Measures

Attrition as measured by the percent of participants completing the study [End of enrollment, approximately 100 days]
Adherence as measured by the percentage of missing data over the course of the study [End of enrollment, approximately 100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Noelle Carlozzi, Ph.D, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noelle E Carlozzi, Associate Professor of Physical Medicine and Rehabilitation, University of Michigan

ClinicalTrials.gov Identifier:

NCT04556591

Other Study ID Numbers:

HUM00184455

First Posted:

Sep 21, 2020

Last Update Posted:

Sep 2, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Noelle E Carlozzi, Associate Professor of Physical Medicine and Rehabilitation, University of Michigan

Depression

Insomnia

Stress related disorders

Anxiety

Study Results

No Results Posted as of Sep 2, 2021