GoKawiilRemote recruitment of participants through the GHS platform
The study protocol was approved by Advarra (IRB no. Pro00074093). Participants were recruited using the Google Health Services (GHS) and the Fitbit applications. GHS is a platform for running digital studies that allows participants to enrol, check eligibility and provide informed consent. GHS enables the collection of data from wearables (Fitbit devices or Pixel watches) and allows participants to complete questionnaires and order blood tests through Quest Diagnostics. In addition to the consent, participants were asked to sign the Quest HIPAA authorization as part of the consent flow within the GHS app. This study resulted in the enrolment of 4,416 participants in the USA, a subset of whom (n = 1,165) had complete data and were therefore included in our analysis. The study was performed remotely with one visit to a Quest Patient Service Center for a blood draw. Participants were asked to wear their wrist-worn devices continuously, schedule and complete a blood draw and answer questionnaires.
Inclusion criteria included: participants residing in the USA aged between 21 and 80; Android Fitbit users who wear a Fitbit device or a Pixel watch with heart-rate-sensing capabilities; users who have at least three months of existing data in which they have used the device for at least 75% of the days to track their activity and sleep; participants willing to update their Fitbit Android app; participants willing to install or update their GHS app on their Android phone; participants willing to link their Quest Diagnostics account to the GHS app (or create an account); participants able to speak and read English and provide informed consent and HIPAA authorization to take part in the study; and participants with access to and who are willing to go to a Quest Diagnostics location for blood draws.
Exclusion criteria included participants living in Alaska, Arizona, Hawaii and the US territories, because Quest Diagnostics cannot provide blood tests in those states; participants with uncontrolled disease (for example, a recent change in treatment in the past six weeks, awaiting review to trigger a change of treatment, a treating physician has indicated the condition is not yet controlled, or where symptoms of the condition are not responding to treatment); and participants with conditions that might make collecting blood samples through venipuncture impractical.
Study design
As part of this study, participants were asked to link their Fitbit account with the GHS app. They were also asked to grant GHS permission to collect Fitbit data throughout the study, including data for up to three months before study enrolment. Once participants were enrolled in the study they were asked to do the following: (1) wear their Fitbit device or Pixel watch during the day and while they sleep (at least three out of every four days) for the duration of the study; (2) complete four questionnaires, which covered (i) demographic information, (ii) health history and health information, such as sleep and exercise habits, (iii) participant perception of health, and (iv) blood test interpretation (see below for details); (3) schedule an appointment to complete the laboratory test orders that were placed for them and go to a Quest Patient Service Center for a blood draw within 65 days of enrolment; (4) complete a blood draw at the Quest Patient Service Center; (5) review blood test results in the GHS app when available.
Collection of metadata
Demographics (for example, age, gender, ethnicity, weight and height), optional measures, such as medical conditions (for example, diabetes, hyperlipidaemia, cardiovascular disease, kidney disease, hypertension and so on), blood pressure, waist circumference, medications, self-reported health management and habits were collected through a baseline questionnaire that participants completed immediately after enrolment through the GHS app.
Blood biomarker measurements at Quest Diagnostics
Eligible participants were asked to schedule and complete a visit to a Quest Diagnostics Patient Service Center of their choice in their local area. This visit included a standard blood draw to measure the following: complete blood count, CMP, insulin, total cholesterol, triglycerides, HDL cholesterol, calculated LDL cholesterol, HbA1c, high-sensitivity CRP, hepatic panel, gamma-glutamyl transferase (GGT) and total testosterone. For this research study, we only had access to this predefined set of laboratory tests and did not collect or receive any blood test data not included in this study. Participants were asked to have their blood drawn while fasting for at least eight hours, in the early morning, 07:00–10:00 local time, to minimize the effect of the solar diurnal cycle. This study also had clinical oversight by a physician network partner. Laboratory results from the blood draw were returned to participants and made available for participant review in the GHS app for the duration of the study; however, these were pulled directly from Quest Diagnostics each time this was requested by the participant and were not stored in the GHS app. Participants provided consent and HIPAA authorization to grant GHS permission to collect the corresponding results from Quest Diagnostics. Data transferred from Quest Diagnostics were retrieved securely using encrypted protocols. Once the study was completed, laboratory results remained in the participant’s Quest Account in accordance with Quest’s standard practices.
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