Asthma Digital Study

Asthma Clinical Trial

— ADS  

Official title:

Digital Tools for Improved Awareness and Self-Management of Asthma in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609644
• Other study ID #: HS# 2020-5711
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: November 4, 2023

Study information

• Verified date: November 2023
• Source: Anthem, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: November 4, 2023
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Digital Tools for Asthma Self-Management
Please see description of active study arm.

Locations

Country	Name	City	State
United States	Jordan Silberman	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Anthem, Inc	Apple Inc., CareEvolution, LLC, HealthCore, Inc., University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control	Change from baseline among active arm participants with baseline ACT score suggesting that asthma may be uncontrolled (ACT score of 19 or lower).	Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Secondary	Adherence to Refills and Medications Scale, 7-item version (ARMS-7)	Validated PRO measure of medication adherence	Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Secondary	Readiness ruler, asthma self-management	PRO measuring confidence in, and perceived importance of, asthma self-management	Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Secondary	Work Productivity and Activity Impairment Questionnaire 2.0, asthma version	Validated PRO measure of asthma-associated work productivity impairment	Active arm only: Baseline and months 1, 3, 5, 8, 12
Secondary	Health Confidence Score	Validated PRO measure of confidence in ability to manage general health	Active arm only: Baseline and months 1, 3, 5, 8, 12
Secondary	Self-reported smoking and e-cigarette use	Adaptations of validated PRO measures	Baseline and month 12
Secondary	Symptom-free days	Measured using Study App	Active arm only: Months 1-12
Secondary	Frequency of prescriptions for oral corticosteroids		Months 1-12; Months 13-24
Secondary	Asthma Medication Ratio	For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/	Months 1-12; Months 13-24
Secondary	Adherence to asthma medications	Proportion of days covered, measured using pharmacy claims	Months 1-12; Months 13-24
Secondary	Asthma-associated expenditures due to emergency department and hospital utilization	Computed in the same manner as the primary outcome, except that expenditures are computed for Year 2 rather than Year 1.	Months 13-24
Secondary	Total Asthma-Associated Expenditures	Total allowed costs for all care associated with asthma, including pharmacy and other costs	Months 1-12; Months 13-24
Secondary	Total Medical Expenditures	Total allowed costs for all claimed healthcare expenses	Months 1-12; Months 13-24
Secondary	Frequency of unplanned visits for asthma care	Includes acute primary care visits, urgent care visits, emergency visits	Months 1-12; Months 13-24
Secondary	Study App Engagement Metrics	Frequencies of symptom tracking, trigger tracking, app opens	Active arm only: Months 1-12; Months 13-24
Secondary	Rates of enrollment in pharmacy auto-refill and home delivery services		Months 1-12; Months 13-24