An Alternative to the Light Touch Digital Health Remote Study: The Stress and Recovery in Frontline COVID-19 Health Care Workers Study

Background Several app-based studies share similar characteristics of a light touch approach that recruit, enroll, and onboard via a smartphone app and attempt to minimize burden through low-friction active study tasks while emphasizing the collection of passive data with minimal human contact. However, engagement is a common challenge across these studies, reporting low retention and adherence. Objective This study aims to describe an alternative to a light touch digital health study that involved a participant-centric design including high friction app-based assessments, semicontinuous passive data from wearable sensors, and a digital engagement strategy centered on providing knowledge and support to participants. Methods The Stress and Recovery in Frontline COVID-19 Health Care Workers Study included US frontline health care workers followed between May and November 2020. The study comprised 3 main components: (1) active and passive assessments of stress and symptoms from a smartphone app, (2) objective measured assessments of acute stress from wearable sensors, and (3) a participant codriven engagement strategy that centered on providing knowledge and support to participants. The daily participant time commitment was an average of 10 to 15 minutes. Retention and adherence are described both quantitatively and qualitatively. Results A total of 365 participants enrolled and started the study, and 81.0% (n=297) of them completed the study for a total study duration of 4 months. Average wearable sensor use was 90.6% days of total study duration. App-based daily, weekly, and every other week surveys were completed on average 69.18%, 68.37%, and 72.86% of the time, respectively. Conclusions This study found evidence for the feasibility and acceptability of a participant-centric digital health study approach that involved building trust with participants and providing support through regular phone check-ins. In addition to high retention and adherence, the collection of large volumes of objective measured data alongside contextual self-reported subjective data was able to be collected, which is often missing from light touch digital health studies. Trial Registration ClinicalTrials.gov NCT04713111; https://clinicaltrials.gov/ct2/show/NCT04713111


PPE and Exposure Scale* Daily
The PPE scale is an assessment of protective equipment usage for virus exposure prevention.

Self-Assessment Mannequin (SAM)* Daily
The SAM is a 5-point icon-based assessment of daily mood, energy, cognition, stress, cough.
Daily Stress* Daily The Daily Stress Measurement is a brief questionnaire assessing an individual's daily stress experience.
CANTAB Emotional Bias Test (EBT) 30 Every other day Active task that detects perceptual bias in facial emotion perception CANTAB Psychomotor Vigilance Test (PVT) Every other day Active task that objectively assessed fatigue-related changes in alertness associated with sleep loss, extended wakefulness, circadian misalignment, and time on task.
Cogkit N-Back Test 31 Every other day Active task that assesses working memory recall in an individual. It has not been validated, however is deemed useful for experimental research on working memory 31 Healthkit Trail Making Test 29, 39 Every other day Active task in which an individual is asked to connect a series of numbered dots, assessing visual attention and task switching. The TMT is a validated measure with correlations between alternative forms of Trails A and BD ranging between r=.76 to r=. 94. 29 Healthkit Reaction Time Test 29, 40 Every other day Active task in which an individual is asked to shake their device when a blue dot appears, assessing reaction. Similar mobile-device reaction tests have been found to have high reliability and observed power of 0.96 (n = 27, α < 0.05, effect size = 0.59) 40 Patient Health Questionnaire-9 (PHQ-9) 46 Every two weeks The PHQ-9 is a validated 9-item measure of an individual's depressive symptoms over the past 2 weeks that has a sensitivity of 88% and a specificity of 88% for major depression. 46 General Anxiety Disorder-7 (GAD-7) 47 Every 2 weeks The GAD-7 is a validated 7-item measure of an individual's anxiety symptoms over the past 2 weeks ( Table 3. Check-in insights from participants and engagement specialists

Study Feature Insights from Participants
Study app experience -Several themes noted by participants that would help with completion of daily tasks centered on ease of usability, highlighting the importance of integration of 3rd party applications in the central study app, non-reliance on web-based 3rd party applications and individual tailoring of the app experience (custom push notifications and survey completion windows). -Keeping individual surveys short (e.g., <1 minute) was noted as important. While completing several surveys that totalled approximately 5 minutes per day was acceptable, individual surveys that were longer (3-5 minutes) were less acceptable as participants had to find longer chunks of time in their day for completion. However, a collection of short surveys that could be completed at different times was more acceptable. -Privacy concerns were noted relating to third party applications of a "surveillance" nature. We found that communicating with participants in the context of why we are collecting certain data points such as total screen time from Rescue Time helped with adherence. There were some misperceptions of how these 3rd party applications use data. For example, while RescueTime requests to access location, these data are used for the app's functionality to track screen time, and remains on the users device, and is not sent to Rescue Times servers. Study Measures -Survey measures with non-applicable wording and repetitiveness when variation in the construct was minimal were a noted annoyance and produced participant fatigue. For example, personal protective equipment changes were initially measured on a daily basis, but from both reviewing the variation in the data, and from participant insights, this was too often and accordingly, was changed to a weekly cadence. For some measures, it is unclear whether variation at a daily level exists in unpredictable scenarios, which was the case in the early months of the pandemic. Having the capability to change these cadences may reduce annoyances for participants, and in turn improve adherence. -Some participants noted consistent challenges with cognitive active tasks, while others found these tasks fun. Cognitive tasks are intended to be challenging, yet when administered at higher frequencies produce additional burden and in some participants, these tasks were felt to impact self-esteem. We found that again, communicating context to participants as to why we are collecting certain measures improved understanding. -Participants expressed interest in receiving summaries of their survey data.

Wearables
-Challenges in using the study wearable devices included wearing the ring during activities, worry over losing the ring, actually losing the ring, technical issues and the want for more information on This can produce problems in data flow. -Perceived utility of the objective data was questioned by some, and there was a general want for more information on how to interpret the returned objective data. There was a general interest in being enabled to track objective sleep metrics while some found these notifications from the app frustrating as they were non-actionable. For example, the Oura ring makes recommendations on pushing yourself, or taking a break based on last night's sleep quality scores and how well you have recovered. Acting on these prompts is challenging for healthcare professionals who work shift work and was a noted frustration by some. Others noted a positive experience from these notifications, suggesting this actually produced behaviour change. Taken together, the significant importance of availability of engagement experts to assist with wearable device orientation, to troubleshoot technological issues and to discuss the nature of the data captured from these devices was very evident. Check-in calls -In general, these check-in calls were well received and enjoyed by participants. Only 2 participants did not engage with these calls during participation. Not all participants were interested in talking on the phone and noted a preference to have the option of using text, email, and in some, video chats like Facetime. -Feedback from engagement specialists indicated the exercise of reviewing participant data prior to the check-in was useful for gaining context and understanding a greater depth of participant experience. The shift in nature of questions was to gain a better understanding and context around the participants' stress, and perceived sources of stress and how they were interacting with the digital devices and apps. Wearables -Realizing that some participants were able to wear wearable devices while on shift, and because of feedback from participants wanting to know what they're objective physiological measures looked like while at work, a new sub-arm was introduced where participants were provided with a Garmin Vivoactive 4 Smartwatch to wear while on shift. Other -In response to participant feedback and wanting to reduce their stress, a new lifestyle intervention sub-arm was introduced where participants were invited to participate in a four-week physical exercise, or a meditation/mindfulness arm where we provided free access to the Headspace App. -A new participant benefit stress reduction tool was introduced called YELL-IT where participants could call a number and leave a voice message of their choice that could include any release that might offer them benefit. -An additional sub-arm to collect a one-time hair sample to assess participants' cortisol concentrations as a proxy of they're past chronic stress was included.

Overview
Participants had the choice to participate in one or all of the following sub-arms: Lifestyle intervention, wearable on shift, and hair cortisol. The sub-arms were announced during the joint investigator/participant zoom meeting and during bi-weekly check-ins. Eligible and interested participants contacted their engagement specialist expressing interest in participating, or did so during a biweekly check-in. Interested and eligible participants were sent a new REDCap link to consent to participate in these sub-arms.

Intervention sub-arm
Purpose: • To offer a stress alleviating intervention to participants (to give something back) and see if there is a detectable shift in stress signal in this sub-arm compared to the remainder of the sample not participating in this arm.
Inclusion criteria: • Any currently enrolled participant expressing interest with four weeks left of study participation or is willing to extend full study participation post four months Exclusion criteria: • If already engaging in both inward (meditation/mindfulness-based techniques) and outward activities (physical exercise) more than twice a week. • If engaging in only one of these activities more than twice a week, then the participant had to choose the other activity.
Procedure: • Participants were given study instructions over the phone with their engagement specialist and were sent an instructional package via email that includes two choices of lifestyle interventions (inward and outward activities). Interested participants were offered to choose one of the interventions to partake in for four consecutive weeks.

Interventions: • Meditation/mindfulness and lifestyle (Inward)
• Participants were provided with a free subscription to Headspace https://www.headspace.com/ and were instructed to download the app from the app store. Participants were instructed to become familiar with the app and try out a few meditation sessions to find what type of sessions best suit them and were instructed to complete 3-5 or more sessions per week during the 4-week participation.
• Physical exercise (Outward) o Participants were provided with a resource comprising a variety of free online fitness classes and were instructed to engage in 30 minutes to 1 hour of physical exercise, 2-3 times a week or more that could include an exercise of their choice (e.g., running, strength training, yoga, pilates, barre).

On shift wearables sub-arm
Purpose: During the course of the Stress and Recovery main study we were informed by some participants that smartwatches were allowable at some workplaces. The main study was collecting off-shift objective stress data from the Oura ring, but the ring does not work during the day and is not intended for the collection of daytime objective data. We included the Garmin Vivoactive 4 smartwatch to collect on work shift objective stress data (e.g., heart rate, heart rate variability, respiratory rate and activity).

Inclusion criteria
• Participants who are 'likely' to not work with COVID-19 patients or have several consecutive days where they will not work with COVID-19 patients in the next 3-4 weeks • Participant's place of work allows wearable devices to be worn while on shift • Willing to wear a smartwatch while on shift • Have 4 weeks left of study participation or is willing to extend full study participation post 4 months Procedure: • Consenting participants were shipped a Garmin smartwatch and were sent instructions on its use via email. Participants were instructed to wear the device while on shift for 4 consecutive weeks. Participants will be able to keep these devices. • The Garmin (Vivoactive 4) (https://buy.garmin.com/en-CA/CA/p/643382#overview) is a lightweight, smartwatch comprising a slate stainless steel bezel and a silicone band that collects the following metrics: Respiration rate (daytime/night time), SpO2 (daytime/nighttime), HRV stress score (daytime), HR (daytime/nighttime), sleep stages and quality metrics, Duration, intensity, and timing of activities, Inactivity, sedentary time