Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial

Abstract

Background Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted 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 named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation. Methods The Roadmap 2.0 intervention will consist of a mobile randomized trial 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, 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. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records. Results We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app. Conclusions This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life 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. Trial Registration ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844 International Registered Report Identifier (IRRID) PRR1-10.2196/19288

Risk Factors for COVID-19 in College Students Identified by Physical, Mental, and Social Health Reported During the Fall 2020 Semester: Observational Study Using the Roadmap App and Fitbit Wearable Sensors

“…The Roadmap platform was initially developed to provide support to patients and their family caregivers in health care delivery (eg, information, education, and skills-based training) because of its accessibility and scalability [ 17 - 23 ]. This platform was iteratively enhanced to support the health and well-being of the user and to aggregate their raw step and sleep counts, which were collected through the Fitbit [ 24 ].…”

Monitoring Beliefs and Physiological Measures Using Wearable Sensors and Smartphone Technology Among Students at Risk of COVID-19: Protocol for a mHealth Study

“…Given the impact of the COVID-19 pandemic on college students, this study aimed to monitor student health and mental well-being. This study utilized the Roadmap 2.0 app, which is currently being evaluated among caregivers of patients undergoing hematopoietic stem cell transplantation [10][11][12]. The Roadmap 2.0 app was used to interface with a wearable sensor data from the Fitbit device and to deliver surveys to the subjects.…”

Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology: Protocol for an Observational mHealth Study

“…Our research team recently developed the Roadmap 2.0 mobile health app, which includes positive psychology-based activities for users with the goal of enhancing well-being and HRQOL for family caregivers of patients undergoing hematopoietic cell transplantation (HCT) [17][18][19]. The mobile randomized trial in HCT caregivers is currently ongoing (ClinicalTrials.gov NCT04094844) [20].…”

“…Study participants responded to all surveys on their smartphones through the Roadmap 2.0 app, which was also used to interface with the Fitbit data through an API [21]. This app was originally developed by author SWC and colleagues as part of a project funded by a National Heart, Lung, and Blood Institute (NHLBI) R01 grant, R01HL146354-01, and is currently being evaluated in a study of caregivers of HCT patients [17][18][19]. As an added potential benefit to the participants, the Roadmap 2.0 app included a set of positive psychology-based activities that participants could use if they desired, including positive piggy bank, gratitude diary, savoring, pleasant activity scheduling, random acts of kindness, signature strengths, love letter, and engaging with beauty.…”