Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
2 other identifiers
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 21, 2023
February 1, 2023
7 months
September 14, 2020
May 31, 2022
February 20, 2023
Conditions
Keywords
Outcome Measures
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
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 Outcomes (2)
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
Study Arms (2)
Control
ACTIVE COMPARATORParticipants 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)
EXPERIMENTALParticipants 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.
Interventions
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.
Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Is a professional, paid caregiver (e.g., home health aide)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (4)
Wang J, Wu Z, Choi SW, Sen S, Yan X, Miner JA, Sander AM, Lyden AK, Troost JP, Carlozzi NE. The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study. JMIR Form Res. 2023 Sep 14;7:e43099. doi: 10.2196/43099.
PMID: 37707948DERIVEDCarlozzi NE, Choi SW, Wu Z, Sen S, Troost J, Lyden AK, Miner JA, Graves C, Sander AM. The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups. J Patient Rep Outcomes. 2023 Jun 26;7(1):57. doi: 10.1186/s41687-023-00602-x.
PMID: 37358716DERIVEDCarlozzi NE, Choi SW, Wu Z, Troost JP, Lyden AK, Miner JA, Graves CM, Wang J, Yan X, Sen S. An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study. Rehabil Psychol. 2022 Nov;67(4):497-512. doi: 10.1037/rep0000472.
PMID: 36355640DERIVEDCarlozzi NE, Choi SW, Wu Z, Miner JA, Lyden AK, Graves C, Wang J, Sen S. An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Dec 9;10(12):e32842. doi: 10.2196/32842.
PMID: 34889775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Noelle E. Carlozzi
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Noelle Carlozzi, Ph.D
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 21, 2020
Study Start
November 5, 2020
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
March 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The data will be available after the acceptance for publication of the main findings from the final dataset.
- Access Criteria
- Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu.
Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan Project Manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.