Asthma Digital Study (ADS)

Elevance Health

Status: Completed

Conditions: Asthma

Treatments: Other: Digital Tools for Asthma Self-Management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04609644

HS# 2020-5711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 901 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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901 participants in 2 patient groups

Passive

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Digital Tools for Asthma Self-Management