Clinical trial NCT04609644: Asthma Digital Study
Official title: Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Elevance Health
Sponsor class: INDUSTRY
Collaborators: name: Apple Inc.
name: University of California, Irvine
name: HealthCore, Inc.
name: CareEvolution, LLC
First posted: 2020-10-30
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in asthma-associated expenditures due to emergency department and hospital utilization
timeFrame: 12 months before and after baseline
measure: Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
timeFrame: Baseline and 12-month time points
Secondary outcomes:
measure: Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
timeFrame: Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
measure: Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
timeFrame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
measure: Readiness ruler, asthma self-management
timeFrame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
measure: Work Productivity and Activity Impairment Questionnaire 2.0, asthma version
timeFrame: Active arm only: Baseline and months 1, 3, 5, 8, 12
measure: Health Confidence Score
timeFrame: Active arm only: Baseline and months 1, 3, 5, 8, 12
measure: Self-reported smoking and e-cigarette use
timeFrame: Baseline and month 12
measure: Symptom-free days
timeFrame: Active arm only: Months 1-12
measure: Frequency of prescriptions for oral corticosteroids
timeFrame: Months 1-12; Months 13-24
measure: Asthma Medication Ratio
timeFrame: Months 1-12; Months 13-24
measure: Adherence to asthma medications
timeFrame: Months 1-12; Months 13-24
measure: Asthma-associated expenditures due to emergency department and hospital utilization
timeFrame: Months 13-24
measure: Total Asthma-Associated Expenditures
timeFrame: Months 1-12; Months 13-24
measure: Total Medical Expenditures
timeFrame: Months 1-12; Months 13-24
measure: Frequency of unplanned visits for asthma care
timeFrame: Months 1-12; Months 13-24
measure: Study App Engagement Metrics
timeFrame: Active arm only: Months 1-12; Months 13-24
measure: Rates of enrollment in pharmacy auto-refill and home delivery services
timeFrame: Months 1-12; Months 13-24
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Jordan Silberman
state: California
Study officials:
References:
citation: Silberman J, Sarlati S, Harris B, Bokhari W, Boushey H, Chesnutt A, Zhu P, Sitts K, Taylor TH, Willey VJ, Fuentes E, LeKrey M, Hou E, Kaur M, Niyonkuru C, Muscioni G, Bianchi MT, Bota DA, Lee RA. A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial. Contemp Clin Trials. 2022 Nov;122:106902. doi: 10.1016/j.cct.2022.106902. Epub 2022 Aug 30.
citation: Harris B, Silberman J, Sarlati S, et al. A digital asthma self-management tool reduced emergency visit rates in a Medicaid population. Ann Allergy Asthma Immunol. 2023;131(5):S230-S231. doi:10.1016/j.anai.2023.10.021