Asthma Digital Study

NCT04609644 | Completed FDA Device

• 1 other identifier: HS# 2020-5711
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Change in asthma-associated expenditures due to emergency department and hospital utilization

  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.

  12 months before and after baseline

• Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control

  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.

  Baseline and 12-month time points

Secondary Outcomes (16)

• 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

• Adherence to Refills and Medications Scale, 7-item version (ARMS-7)

  Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12

• Readiness ruler, asthma self-management

  Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12

• Work Productivity and Activity Impairment Questionnaire 2.0, asthma version

  Active arm only: Baseline and months 1, 3, 5, 8, 12

• Health Confidence Score

  Active arm only: Baseline and months 1, 3, 5, 8, 12

Study Arms (2)

Passive

NO INTERVENTION

Passive arm participants will be sent two devices, at no cost-an Apple Watch and a Beddit Sleep Monitor. These are commercially available and have not been modified for this study. Participants will be asked to use these devices regularly throughout study Year 1. Participants can optionally continue to use devices during Year 2, if they have met requirements during Year 1 to keep study devices. To be eligible to keep devices, participants must meet pre-specified levels of adherence to study procedures. 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. However, passive participants will not have access to the Study App features designed to support asthma self-management.

Active

EXPERIMENTAL

Active arm participants will be sent the same devices, also at no cost, and asked to use them in the same manner. Only the active arm will have access to Study App features for asthma self-management, including: * "Smart nudges" that may promote proactive asthma self-management * Asthma symptom and trigger tracking * Evidence-based asthma education * The ability to photograph and easily reference an asthma action plan from a healthcare provider. * A 90-day summary of self-reported asthma symptoms/triggers and device-recorded heart rate and respiratory rate. This summary can be shared with providers. * In-app viewing of active asthma medications, refills available, and phone numbers to call for refills (subject to prescription benefits). Active participants can, but are not required to, use the Study App in Year 2. Those who choose to may keep using study devices in Year 2, provided they meet requirements to keep devices. These requirements are the same for both arms.

Other: Digital Tools for Asthma Self-Management

Interventions

Digital Tools for Asthma Self-Management OTHER

Please see description of active study arm.

Active

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Health insurance coverage through an Anthem, Inc. affiliate.
• 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
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elevance Health: lead
• Apple Inc.: collaborator
• University of California, Irvine: collaborator
• HealthCore, Inc.: collaborator
• CareEvolution, LLC: collaborator

Study Sites (1)

Jordan Silberman

Palo Alto, California, 94301, United States

Location

Related Publications (3)

• 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.

  PMID: 36049674 BACKGROUND

• 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

  BACKGROUND

• Silberman J, Sarlati S, Harris B, Lenyoun H, Kaur M, Wagner BG, Bokhari W, Boushey H, Chesnutt A, Sitts K, Zhu P, Willey VJ, Fuentes E, LeKrey M, Alger BL, Muscioni G, Bianchi MT, Bota DA, Taylor TH, Evans M, Amin AN, Stark D, Montanari C, Perry JS, Vian C, Patel M, Poe W, Lee RA. A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2521438. doi: 10.1001/jamanetworkopen.2025.21438.

  PMID: 40674052 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: October 30, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)