September 30, 2021
University of Michigan PROviding Mental Health Precision Treatment (PROMPT) Digital Clinical Research Study
Clinical Trials & Research
May 27, 2022
University of Michigan’s Precision Health program, Apple, and CareEvolution collaborated to build Michigan Predictive Activity and Clinical Trajectories (MIPACT), a demanding observational research study. Each day, participants took 2 sets of 2 blood pressures, wore their Apple Watch for 12 hours, completed 2 “Breathe” sessions, and provided electronic patient-reported outcomes (ePROs). By using CareEvolution’s MyDataHelps™, a digital clinical trial and research platform, researchers were able to use mobile technology to efficiently collect this data. MyDataHelps™ provided a participant user experience that enrolled 6,735 participants and resulted in 98.3% compliance for Phase 1 of the study. The robust data set, that includes electronic health records (EHR) and genetic information, will be used to understand the relationship between sensor data and different health outcomes.
Mobile technology is pervasive. In 2019, more than eight in ten Americans owned a smartphone, nearly half of Americans tracked an aspect of their health digitally, and one third owned a wearable device. With the advent of wearables and devices to capture digital phenotypes paired with secure, robust digital health platforms like MyDataHelps™, researchers can now capture an unprecedented amount of 360-degree participant data—ePROs (e.g. GAD7, PHQ-9, PROMIS, EMAs) and wearable device data (e.g. steps, heart rate, movement metrics from Apple Watches)—to deepen understanding around predictors for health & wellness, at finely tuned demographic-specific levels.
The MIPACT study was led by Dr. Sachin Kheterpal at University of Michigan. Apple served as sponsor for the study, was involved in the protocol design, provided funding for enrollment, and collected proprietary sensor data from the Apple Watch.
Participants eConsented and enrolled through MyDataHelps™
Heart rate measurements collected over first 90 days
Phase 1 compliance
The study was designed to collect a rich array of biologic, behavioral, social, and symptom data from participants, including:
To meet base compliance, participants were asked to wear Apple Watches at least 12 hours a day while taking 2 BP measurements twice a day for the first 30 days. If participants maintained adherence for at least 15 days, they could keep the Apple Watch they received during enrollment. If participants maintained adherence for at least 30 days during the first 45 days, they received an additional monetary incentive.
The study was split into two phases, one shorter 45-day high-adherence phase and a second, 3-year longitudinal monitoring phase.
Participants were recruited through phone calls, social media, in clinic recruitment and community events, using MyDataHelps™ to screen, enroll, and eConsent participants. Participants were asked to complete baseline surveys, donate a blood sample, wear the Apple watch 12 hours a day, and complete breathing and blood pressure checks twice a day during the first phase of the study.
Recruiting from groups that have largely been underrepresented or unrepresented in digital health research was a large goal for this study. Of the nearly 7,000 participants, 18% were 65 or older, 17% were Black, and 17% were Asian. 10% of participants had diabetes, a third had hypertension and more than a quarter of participants reported depression.
Findings from 45-day High Adherence Phase
Participants 65 and older had significantly lower resting and walking heart rates, and women had resting heart rates on average 3 beats per minute higher than men. When stratified by self-declared race, Black participants had the highest heart rates and white participants the lowest. Activity levels also varied by race and ethnicity and by the presence of certain clinical conditions.
The mean systolic blood pressure was 122 mm Hg (SD 10) and mean diastolic blood pressure was 77 mm Hg (SD 8), with 167,312 (15%) measurements having a systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg. Mean resting heart rate was 64 beats per min (SD 8).
As a cardiologist who takes care of patients dealing with heart failure, it’s important that more than 200 patients in our study have heart failure. Understanding what their baseline information looks like is going to be really informative and allow us to start with more accurate estimates of patients’ activity levels in daily life,
Co-investigator U-M Health’s Division of Cardiovascular Medicine
Participants downloaded the study app, MyDataHelps™, on their smartphone. This app serves as a vehicle for eConsent, data collection, delivery of all study questionnaires, automated notifications, and reminders. Study coordinators walked participants through eConsent during enrollment.
Participants were sent push notifications to remind them to complete certain tasks. The participant dashboard displayed visuals of how close participants were to completing their adherence goals of wearing their Apple Watch >12 hrs a day and taking BP measurements twice a day. The dashboards also displayed how close participants were to the 15-day adherence incentive (keeping Apple Watch) and to the 30-day adherence incentive (monetary compensation).
Participants were given an Apple Watch, which they wore throughout the entire study—allowing daily collection of activity, heart rate, environmental data, and more. They were also given an Omron Evolv wireless blood pressure cuff, which collected data that was also pulled into the MyDataHelps™ app.
Digital clinical platforms like MyDataHelps™ offer great potential to leverage unprecedented data from wearables, while removing barriers to participation for patients. Because of the lower friction of completing ePROs and the automated process of MyDataHelps™ collecting wearable device data and blood pressure cuff measurements, the burden on participants was reduced and the resulting adherence numbers were astounding:
Adherence During First 45 days
Nearly 7,000 participants wore their Apple Watch on almost 90% of the study days for an average of 15.5 hours a day. Overall, 1.1 million blood pressure and more than 200 million heart rate measurements were collected through study devices.