Summary

Eligibility
for people ages 18-64 (full criteria)
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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 smartphone 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.

Keywords

Asthma Digital Tools for Asthma Self-Management Passive

Eligibility

You can join if…

Open to people ages 18-64

  • Health insurance coverage through an Anthem, Inc. affiliate.
  • 18-64 years of age
  • Has been diagnosed with asthma by a provider
  • 1+ emergency department visit in the preceding 24 months with a diagnosis of asthma
  • Resident of the United States for the duration of the study
  • Comfortable reading and writing in English
  • Owns an iPhone 6s or later

You CAN'T join 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:
  • COPD/Emphysema
  • Cystic Fibrosis
  • Any malignancy other than a non-melanoma skin cancer
  • Any dementia diagnosis
  • Neurodegenerative diseases (e.g., ALS, Parkinson's)
  • Obstructive sleep apnea
  • Schizophrenia
  • Heart failure
  • On dialysis
  • Women who are postpartum, with delivery in the past 8 weeks

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Anthem, Inc
ID
NCT04609644
Study Type
Interventional
Last Updated