JMIR Publications

ABSTRACT

Background:

For decades, the nation’s rapidly aging population and rising need for family caregivers have emphasized the urgent need for providing greater support for them. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Thus, the health and well-being of family caregivers have been called to widespread attention. Mobile health technology has been shown to deliver flexible and time- and cost-sparing interventions to support family caregivers across the care trajectory.

Objective:

This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention (Roadmap 2.0). We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Methods:

The Roadmap 2.0 intervention will consist of a mobile randomized trial (mRT) comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life (HRQOL), as assessed by the PROMISⓇ Global Health scale, at day 120 post-transplant. Secondary outcomes will include other PROMISⓇ caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semi-structured qualitative interviews will be conducted in participants at the completion of the study. We will also measure objective physiological markers (e.g., sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through the electronic health record.

Results:

We plan to enroll 166 family caregiver dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval through our Health Information Technology Services. Due to the novel COVID-19 pandemic, the study has been briefly put on hold. However, we anticipate beginning recruitment in June 2020. We have converted all recruitment, enrollment, and onboarding to be conducted remotely through video telehealth. Consenting will be performed electronically through the Roadmap 2.0 app.

Conclusions:

This mRT will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver HRQOL over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes. Clinical Trial: ClinicalTrials.gov identifier NCT040984844.