Recruitment and eligibility
Data used in this retrospective analysis was collected from participants who enrolled in a digital self-management platform (Propeller Health, WI, USA) between January 2018 and March 2019. Participants who enrolled in the platform were recruited via social media campaigns (e.g., Facebook advertisements), and needed to own a smartphone and have a self-reported history of asthma and/or COPD to be eligible. All participants agreed to the platforms Terms of Service.
Data was examined retrospectively using an aggregated dataset. To be included in the analysis, participants needed to be18years of age, reside in the United States, and have a controller inhaler compatible with an electronic medication monitor (EMM). Participants also needed to have at least 97days of controller medication use data (the first seven days of participation was considered an onboarding period). The retrospective analysis plan was determined to be exempt and consent was waived by the Copernicus Independent Review Board (PRH1-18-132). A subset of data used in this retrospective analysis included data previously collected from an electronic survey to which patients provided consent (Protocol 20191728). All methods were carried out in accordance with relevant guidelines and regulations.
Propeller Health is an FDA-cleared digital platform that includes an EMM, and a paired smartphone app targeted to the users self-reported condition (asthma or COPD) (Fig.1).
A small FDA-cleared electronic medication monitor (EMM) is attached to the users controller medication inhaler to capture the date and time of use. Data from the EMM is then transferred wirelessly via Bluetooth to a paired smartphone app providing feedback, insights and medication reminders.
Electronic medication monitors (EMMs) attach to a compatible inhaler medication to passively capture the date and time of use. Usage data is then wirelessly transferred via Bluetooth to a paired smartphone app. The EMM has a battery life of 1218months and does not require charging11. Compatible medications include inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), long-acting muscarinic antagonists (LAMA), and combination therapies (ICS+LABA, LABA/LAMAs and triple therapy).
The paired smartphone app serves not only to collect data from the EMM, but also to engage the user through evidence-based asthma and/or COPD content, including relevant guideline content20,21, feedback on medication use and trends, and schedule-based medication reminders through the EMM and smartphone application. Patients with continued poor medication adherence may be presented with additional gamified features and challenges aimed at improving daily medication adherence. The app also prompts users to complete an in-app Asthma Control Test (ACT) or COPD Assessment Test (CAT) at baseline and monthly thereafter to better assess disease control and burden, respectively (Supplementary Fig.1a,b).
We examined app engagement, defined by daily app opens and app active session duration, as the independent variable. Daily app engagement was defined differently for each model estimate to explore the varying associations of duration on controller medication adherence: Model 1 (no app open vs. any app open regardless of session duration) and Model 2 (no app open vs. at least one app open with<1, 1<5, 510 and 10+minutes of total daily app session duration).
Controller inhaler use was determined using data collected from the EMM, which recorded the date and time of each inhaler actuation. Adherence was calculated by dividing the number of EMM-recorded actuations by the prescribed number of actuations (reported by the participant during enrollment)100 per day.
For the primary analyses, the outcome of controller medication use was dichotomously defined as having taken at least 1 actuation vs. no actuation per day.Controller adherencewas dichotomized because daily adherence was either 0% or 100% on the majority of participant-days (74%). For secondary analyses, controller medication use was defined as being 100% adherent vs.<100% per day. Being 100% adherent was defined as having EMM-recorded controller actuations that were greater than or equal to the total number of prescribed actuations for that day.
Symptom control was assessed with the Asthma Control Test (ACT), a self-administered, validated questionnaire for patients with asthma. The 5-item assessment asks respondents to rate their symptoms on a scale of 15. A score>19 indicates good symptom control, 1519 indicates not well-controlled symptoms, and<15 indicates very poorly controlled symptoms22.
Disease burden for participants with COPD was assessed with the COPD Assessment Test (CAT). The 8-item self-administered questionnaire asks respondents to rate their symptoms on a scale of 15. Summative scores<20 indicate lower disease burden, and scores20 indicate higher disease burden23.
Longitudinal, mixed-effects logistic regressions were used to estimate the association between daily app engagement and daily controller medication adherence during days 897 of EMM use for asthma and COPD, adjusting for age, gender, smartphone type (iOS vs. Android), baseline disease status (defined as initial ACT or CAT score), rescue medication use, day on platform and US Census-derived neighborhood-level income and education. Analyses were also stratified by age and disease severity. Stratification by age was completed for participants 40years and older to allow for comparisons between asthma and COPD. Odds ratios and 95% confidence intervals (CI) were presented, with alpha=0.05 as the significance threshold.
Representatives from the study sponsors (Propeller Health, Council of State and Territorial Epidemiologists) were involved in the study design, collection, analysis and interpretation of data, writing of the report, and in the decision to submit the paper for publication. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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