Asthma Digital Study (NCT04609644) | Clinical Trial Compass
CompletedNot Applicable
Asthma Digital Study
United States901 participantsStarted 2020-10-30
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Neur…
What they're measuring
1
Change in asthma-associated expenditures due to emergency department and hospital utilization
Timeframe: 12 months before and after baseline
2
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control