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 range
18 Years – 64 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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