Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 11, 2021
Date Accepted: Oct 7, 2021
Acceptability and feasibility of an app-based just-in-time-adaptive self-management intervention for care partners: Protocol for the CareQOL pilot trial
ABSTRACT
Background:
Care partners (i.e., informal family caregivers) of individuals with health problems are faced with considerable physical and emotional stress, often with substantial negative impact on the health-related quality of life (HRQOL) of both the care partner and care-recipient. Given that these individuals are often overwhelmed by their caregiving responsibilities, low burden self-management interventions are needed to support caregivers to ensure better patient outcomes.
Objective:
The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention (JITAI) that incorporates passive mobile sensor data feedback (sleep and activity 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.
Methods:
Participants from three diverse care partner groups will be enrolled (care partners of persons with spinal cord injury [SCI]; care partners of persons with Huntington disease [HD]; and care partners of persons with hematopoietic cell transplantation [HCT]). Participants are randomized either to a control group, where they will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period (without the personalized feedback), or the JITAI group, where they will wear the Fitbit®, provide daily reports of HRQOL and receive personalized pushes for 3 months. At the end of the study, participants complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated.
Results:
This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in winter 2021.
Conclusions:
This trial will determine the feasibility and acceptability of an intensive app-based intervention in three distinct caregiver groups: care partners for persons with a chronic condition that was caused by a traumatic event (i.e., SCI); 2) care partners for persons with a progressive, fatal neurodegenerative disease (i.e., HD); and 3) care partners for persons with an episodic cancer condition that requires intense, prolonged inpatient and outpatient treatment (persons with HCT). Clinical Trial: ClinicalTrial.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591
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