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

Background The COVID-19 pandemic triggered a seismic shift in education to web-based learning. With nearly 20 million students enrolled in colleges across the United States, the long-simmering mental health crisis in college students was likely further exacerbated by the pandemic. Objective This study leveraged mobile health (mHealth) technology and sought to (1) characterize self-reported outcomes of physical, mental, and social health by COVID-19 status; (2) assess physical activity through consumer-grade wearable sensors (Fitbit); and (3) identify risk factors associated with COVID-19 positivity in a population of college students prior to release of the vaccine. Methods After completing a baseline assessment (ie, at Time 0 [T0]) of demographics, mental, and social health constructs through the Roadmap 2.0 app, participants were instructed to use the app freely, wear the Fitbit, and complete subsequent assessments at T1, T2, and T3, followed by a COVID-19 assessment of history and timing of COVID-19 testing and diagnosis (T4: ~14 days after T3). Continuous measures were described using mean (SD) values, while categorical measures were summarized as n (%) values. Formal comparisons were made on the basis of COVID-19 status. The multivariate model was determined by entering all statistically significant variables (P<.05) in univariable associations at once and then removing one variable at a time through backward selection until the optimal model was obtained. Results During the fall 2020 semester, 1997 participants consented, enrolled, and met criteria for data analyses. There was a high prevalence of anxiety, as assessed by the State Trait Anxiety Index, with moderate and severe levels in 465 (24%) and 970 (49%) students, respectively. Approximately one-third of students reported having a mental health disorder (n=656, 33%). The average daily steps recorded in this student population was approximately 6500 (mean 6474, SD 3371). Neither reported mental health nor step count were significant based on COVID-19 status (P=.52). Our analyses revealed significant associations of COVID-19 positivity with the use of marijuana and alcohol (P=.02 and P=.046, respectively) and with lower belief in public health measures (P=.003). In addition, graduate students were less likely and those with ≥20 roommates were more likely to report a COVID-19 diagnosis (P=.009). Conclusions Mental health problems were common in this student population. Several factors, including substance use, were associated with the risk of COVID-19. These data highlight important areas for further attention, such as prioritizing innovative strategies that address health and well-being, considering the potential long-term effects of COVID-19 on college students. Trial Registration ClinicalTrials.gov NCT04766788; https://clinicaltrials.gov/ct2/show/NCT04766788 International Registered Report Identifier (IRRID) RR2-10.2196/29561

Background Health care workers (HCWs) have been working on the front lines of the COVID-19 pandemic with high risks of viral exposure, infection, and transmission. Standard COVID-19 testing is insufficient to protect HCWs from these risks and prevent the spread of disease. Continuous monitoring of physiological data with wearable sensors, self-monitoring of symptoms, and asymptomatic COVID-19 testing may aid in the early detection of COVID-19 in HCWs and may help reduce further transmission among HCWs, patients, and families. Objective By using wearable sensors, smartphone-based symptom logging, and biospecimens, this project aims to assist HCWs in self-monitoring COVID-19. Methods We conducted a prospective, longitudinal study of HCWs at a single institution. The study duration was 1 year, wherein participants were instructed on the continuous use of two wearable sensors (Fitbit Charge 3 smartwatch and TempTraq temperature patches) for up to 30 days. Participants consented to provide biospecimens (ie, nasal swabs, saliva swabs, and blood) for up to 1 year from study entry. Using a smartphone app called Roadmap 2.0, participants entered a daily mood score, submitted daily COVID-19 symptoms, and completed demographic and health-related quality of life surveys at study entry and 30 days later. Semistructured qualitative interviews were also conducted at the end of the 30-day period, following completion of daily mood and symptoms reporting as well as continuous wearable sensor use. Results A total of 226 HCWs were enrolled between April 28 and December 7, 2020. The last participant completed the 30-day study procedures on January 16, 2021. Data collection will continue through January 2023, and data analyses are ongoing. Conclusions Using wearable sensors, smartphone-based symptom logging and survey completion, and biospecimen collections, this study will potentially provide data on the prevalence of COVID-19 infection among HCWs at a single institution. The study will also assess the feasibility of leveraging wearable sensors and self-monitoring of symptoms in an HCW population. Trial Registration ClinicalTrials.gov NCT04756869; https://clinicaltrials.gov/ct2/show/NCT04756869 International Registered Report Identifier (IRRID) DERR1-10.2196/29562

BACKGROUND Health care workers (HCWs) have been working in the frontlines of the COVID-19 pandemic with high risks of viral exposure, infection, and transmission. Standard COVID-19 testing is insufficient to protect HCWs from these risks and prevent the spread of disease. Continuous monitoring of physiological data with wearable sensors, self-monitoring of symptoms, and asymptomatic COVID testing may aid in the early detection of COVID-19 in HCWs and may help reduce further transmission among HCWs, patients, and families. OBJECTIVE By using wearable sensors, smartphone-based symptom logging, and biospecimens, this project aimed to assist HCWs in self-monitoring of COVID-19. METHODS We conducted a prospective, longitudinal study of HCWs at a single institution. Study duration was one year, wherein participants were instructed on the continuous use of two wearable sensors (Fitbit Charge 3 smartwatch and TempTraq temperature patches) for up to 30-days. Participants consented to providing biospecimens (e.g., nasal swabs, saliva swabs, blood) for up to one year from study entry. Using a smartphone app called Roadmap 2.0, participants entered a daily mood score, submitted daily COVID-19 symptoms, and completed demographic and health-related quality of life (HRQOL) surveys at study entry and 30 days later. Semi-structured qualitative interviews were also conducted at the end of the 30-day period, following completion of daily mood and symptoms reporting as well as continuous wearable sensor use. RESULTS Two hundred twenty-six HCWs were enrolled between April 28, 2020 and December 07, 2020. The last participant completed the 30-day study procedures on January 16, 2021. Data collection will continue through January 2023, and data analyses are ongoing. CONCLUSIONS Using wearable sensors, smartphone-based symptom logging and survey completion, and biospecimen collections, this study will potentially provide data on the prevalence of COVID-19 infection among HCWs at a single institution. The study will also assess the feasibility of leveraging wearable sensors and self-monitoring of symptoms in a HCW population. CLINICALTRIAL ClinicalTrials.gov #NCT04756869

BACKGROUND Allogeneic hematopoietic stem cell transplantation (HSCT) represents a cancer population with some of the most medically fragile patients and extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. With increased number of allogeneic HSCT being performed worldwide, this expensive procedure has significant economic consequences. 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. CLINICALTRIAL ClinicalTrials.gov identifier NCT040984844.