Asthma
Conditions
Brief summary
The Asthma Digital Study is a virtual, two-arm, randomized, controlled trial that will investigate the impact of digital tools on asthma symptom control, exacerbation frequency, healthcare utilization, and medical expenditures in adults with asthma.
Detailed description
The Asthma Digital Study is a virtual, two-arm, randomized, controlled trial that will investigate the impact of digital tools on asthma symptom control, exacerbation frequency, healthcare utilization, and medical expenditures. Adults with asthma will be randomized to the passive or active arm in a 1:1 ratio. All participants will be sent two devices, at no cost-an Apple Watch and a Beddit Sleep Monitor. These are publicly available, commercial devices that have not been modified for this study. The study will be administered largely through a customized version of CareEvolution's MyDataHelps app (the Study App). Access to the Study App will be provided to all participants. It will be used to administer informed consent and electronic patient reported outcome (ePRO) measures, and for other study purposes. Only active arm participants will have access to Study App features designed to support asthma self-management. These features include smart nudges based on device data, symptom and trigger tracking, evidence-based education, summaries of health metrics gathered from the Apple Watch and Beddit Sleep Monitor, in-app medication refill resources, as well as other resources. The study duration is 2 years. Participants can keep using the Study App and devices after Year 1, though this is not required. Primary analyses will utilize Year 1 data only. During Year 2, data collection will continue where available, though fewer data will be collected because use of digital tools is not required during Year 2, and health coverage changes may cause loss of access to claims data.
Interventions
OTHERDigital Tools for Asthma Self-Management
Please see description of active study arm.
Sponsors
Apple Inc.
University of California, Irvine
HealthCore, Inc.
CareEvolution, LLC
Elevance Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Health insurance coverage through an Anthem, Inc. affiliate. * 18-64 years of age * Resident of the United States for the duration of the study * Comfortable reading and writing in English * Owns an iPhone 6s or later * Has been diagnosed with asthma by a provider * 1+ emergency department visit in the preceding 24 months with an associated asthma diagnosis, or a combination of factors that might be associated with uncontrolled asthma. Factors include: * History of asthma medication prescriptions * History of asthma-associated primary care visits * Diagnosis of chronic sinusitis, pharyngitis, influenza, allergic rhinitis, hypertension, diabetes, and/or obesity * History of smoking * Age and zip code
Exclusion criteria
* Unable to sleep in a bed with a Beddit sleep monitor at least 5 nights per week on average (e.g., shift workers who experience limited or erratic night-time sleep schedule, frequent travelers unable to stably sleep on the sensor at the requisite rate) * Currently enrolled in any other asthma or pulmonary studies * Currently on any immunologic for asthma * Participated in a prior pilot study investigating the same digital tools * Member of an Anthem plan with annual incentives limits of $100 or less * Resident of Puerto Rico * Pregnancy * Diagnosis of any of the following: * Chronic Obstructive Pulmonary Disease/Emphysema * Cystic Fibrosis * Any malignancy other than a non-melanoma skin cancer * Any dementia diagnosis * Neurodegenerative diseases (e.g., Parkinson's) * Schizophrenia * Heart failure * On dialysis * Women who are postpartum, with delivery in the past 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in asthma-associated expenditures due to emergency department and hospital utilization | 12 months before and after baseline | Sum of all allowed costs for emergency and hospital care, where asthma is specified as a diagnosis. Costs from the 12 months preceding baseline will be compared to costs from 12 months after baseline. Mean change in costs will be compared across arms. |
| Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control | Baseline and 12-month time points | ACT change among all participants with baseline ACT score suggesting that asthma may be uncontrolled (ACT score of 19 or lower). Mean ACT change will be compared across arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readiness ruler, asthma self-management | Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12 | PRO measuring confidence in, and perceived importance of, asthma self-management |
| Work Productivity and Activity Impairment Questionnaire 2.0, asthma version | Active arm only: Baseline and months 1, 3, 5, 8, 12 | Validated PRO measure of asthma-associated work productivity impairment |
| Health Confidence Score | Active arm only: Baseline and months 1, 3, 5, 8, 12 | Validated PRO measure of confidence in ability to manage general health |
| Self-reported smoking and e-cigarette use | Baseline and month 12 | Adaptations of validated PRO measures |
| Symptom-free days | Active arm only: Months 1-12 | Measured using Study App |
| Frequency of prescriptions for oral corticosteroids | Months 1-12; Months 13-24 | — |
| Asthma Medication Ratio | Months 1-12; Months 13-24 | For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/ |
| Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control | Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12 | Change from baseline among active arm participants with baseline ACT score suggesting that asthma may be uncontrolled (ACT score of 19 or lower). |
| Asthma-associated expenditures due to emergency department and hospital utilization | Months 13-24 | Computed in the same manner as the primary outcome, except that expenditures are computed for Year 2 rather than Year 1. |
| Total Asthma-Associated Expenditures | Months 1-12; Months 13-24 | Total allowed costs for all care associated with asthma, including pharmacy and other costs |
| Total Medical Expenditures | Months 1-12; Months 13-24 | Total allowed costs for all claimed healthcare expenses |
| Frequency of unplanned visits for asthma care | Months 1-12; Months 13-24 | Includes acute primary care visits, urgent care visits, emergency visits |
| Study App Engagement Metrics | Active arm only: Months 1-12; Months 13-24 | Frequencies of symptom tracking, trigger tracking, app opens |
| Rates of enrollment in pharmacy auto-refill and home delivery services | Months 1-12; Months 13-24 | — |
| Adherence to asthma medications | Months 1-12; Months 13-24 | Proportion of days covered, measured using pharmacy claims |
| Adherence to Refills and Medications Scale, 7-item version (ARMS-7) | Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12 | Validated PRO measure of medication adherence |
Countries
United States
Outcome results
None listed