AsthmaADSNCT04609644
Asthma Digital Study
A study testing Digital Tools for Asthma Self-Management in people with Asthma, run by Elevance Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Asthma
- What is being tested?
- Digital Tools for Asthma Self-Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 4 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
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.
Read the detailed 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.
- Conditions
- Asthma
- Being tested
- Digital Tools for Asthma Self-Management
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Tools for Asthma Self-ManagementOther
Please see description of active study arm.
| Study group | Role | What they receive |
|---|---|---|
| Passive | No intervention | 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 | 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. Receives: Other: Digital Tools for Asthma Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months before and after baseline
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.
Measured: Baseline and 12-month time points
Secondary outcomes (16)
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).
Measured: Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
Validated PRO measure of medication adherence
Measured: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Readiness ruler, asthma self-management
PRO measuring confidence in, and perceived importance of, asthma self-management
Measured: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Work Productivity and Activity Impairment Questionnaire 2.0, asthma version
Validated PRO measure of asthma-associated work productivity impairment
Measured: Active arm only: Baseline and months 1, 3, 5, 8, 12
Health Confidence Score
Validated PRO measure of confidence in ability to manage general health
Measured: Active arm only: Baseline and months 1, 3, 5, 8, 12
Self-reported smoking and e-cigarette use
Adaptations of validated PRO measures
Measured: Baseline and month 12
Symptom-free days
Measured using Study App
Measured: Active arm only: Months 1-12
Frequency of prescriptions for oral corticosteroids
Measured: Months 1-12; Months 13-24
Asthma Medication Ratio
For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/
Measured: Months 1-12; Months 13-24
Adherence to asthma medications
Proportion of days covered, measured using pharmacy claims
Measured: Months 1-12; Months 13-24
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.
Measured: Months 13-24
Total Asthma-Associated Expenditures
Total allowed costs for all care associated with asthma, including pharmacy and other costs
Measured: Months 1-12; Months 13-24
Total Medical Expenditures
Total allowed costs for all claimed healthcare expenses
Measured: Months 1-12; Months 13-24
Frequency of unplanned visits for asthma care
Includes acute primary care visits, urgent care visits, emergency visits
Measured: Months 1-12; Months 13-24
Study App Engagement Metrics
Frequencies of symptom tracking, trigger tracking, app opens
Measured: Active arm only: Months 1-12; Months 13-24
Rates of enrollment in pharmacy auto-refill and home delivery services
Measured: Months 1-12; Months 13-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start30 Oct 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elevance Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apple Inc., University of California, Irvine, HealthCore, Inc., CareEvolution, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609644
- Sponsor's protocol ID
- HS# 2020-5711
- Acronym
- ADS
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36049674Harris 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, Lenyoun H, Kaur M, Wagner BG, Bokhari W, Boushey H, Chesnutt A, Sitts K, Zhu P, Willey VJ, Fuentes E, LeKrey M, Alger BL, Muscioni G, Bianchi MT, Bota DA, Taylor TH, Evans M, Amin AN, Stark D, Montanari C, Perry JS, Vian C, Patel M, Poe W, Lee RA. A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2521438. doi: 10.1001/jamanetworkopen.2025.21438.
PubMed 40674052
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
- ClinicalTrials.gov ID
- NCT04609644
- Acronym / sponsor ID
- ADS / HS# 2020-5711
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Elevance HealthIndustry (pharma, biotech, devices)
- Collaborators
- Apple Inc., University of California, Irvine, HealthCore, Inc., CareEvolution, LLC
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive | No intervention | –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 | Other: Digital Tools for Asthma Self-ManagementActive 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Tools for Asthma Self-ManagementPlease see description of active study arm. | Other | Active |
Primary outcome
Change in asthma-associated expenditures due to emergency department and hospital utilization
Time frame: 12 months before and after baseline
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.
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
Time frame: Baseline and 12-month time points
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.
16 secondary outcomes
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
Time frame: Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
Time frame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Readiness ruler, asthma self-management
Time frame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Work Productivity and Activity Impairment Questionnaire 2.0, asthma version
Time frame: Active arm only: Baseline and months 1, 3, 5, 8, 12
Health Confidence Score
Time frame: Active arm only: Baseline and months 1, 3, 5, 8, 12
Self-reported smoking and e-cigarette use
Time frame: Baseline and month 12
Symptom-free days
Time frame: Active arm only: Months 1-12
Frequency of prescriptions for oral corticosteroids
Time frame: Months 1-12; Months 13-24
Asthma Medication Ratio
Time frame: Months 1-12; Months 13-24
Adherence to asthma medications
Time frame: Months 1-12; Months 13-24
Asthma-associated expenditures due to emergency department and hospital utilization
Time frame: Months 13-24
Total Asthma-Associated Expenditures
Time frame: Months 1-12; Months 13-24
Total Medical Expenditures
Time frame: Months 1-12; Months 13-24
Frequency of unplanned visits for asthma care
Time frame: Months 1-12; Months 13-24
Study App Engagement Metrics
Time frame: Active arm only: Months 1-12; Months 13-24
Rates of enrollment in pharmacy auto-refill and home delivery services
Time frame: Months 1-12; Months 13-24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 36049674Silberman 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.
- BackgroundHarris 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
- Derived from this study: PubMed 40674052Silberman J, Sarlati S, Harris B, Lenyoun H, Kaur M, Wagner BG, Bokhari W, Boushey H, Chesnutt A, Sitts K, Zhu P, Willey VJ, Fuentes E, LeKrey M, Alger BL, Muscioni G, Bianchi MT, Bota DA, Taylor TH, Evans M, Amin AN, Stark D, Montanari C, Perry JS, Vian C, Patel M, Poe W, Lee RA. A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2521438. doi: 10.1001/jamanetworkopen.2025.21438.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Tools for Asthma Self-Management in people with Asthma, run by Elevance Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma-associated expenditures due to emergency department and hospital utilization (time frame: 12 months before and after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.