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Asthma Digital Study (ADS)

Primary Purpose

Asthma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Tools for Asthma Self-Management
Sponsored by
Anthem, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Jordan Silberman

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Passive

Active

Arm 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 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
Validated PRO measure of medication adherence
Readiness ruler, asthma self-management
PRO measuring confidence in, and perceived importance of, asthma self-management
Work Productivity and Activity Impairment Questionnaire 2.0, asthma version
Validated PRO measure of asthma-associated work productivity impairment
Health Confidence Score
Validated PRO measure of confidence in ability to manage general health
Self-reported smoking and e-cigarette use
Adaptations of validated PRO measures
Symptom-free days
Measured using Study App
Frequency of prescriptions for oral corticosteroids
Asthma Medication Ratio
For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/
Adherence to asthma medications
Proportion of days covered, measured using pharmacy claims
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.
Total Asthma-Associated Expenditures
Total allowed costs for all care associated with asthma, including pharmacy and other costs
Total Medical Expenditures
Total allowed costs for all claimed healthcare expenses
Frequency of unplanned visits for asthma care
Includes acute primary care visits, urgent care visits, emergency visits
Study App Engagement Metrics
Frequencies of symptom tracking, trigger tracking, app opens
Rates of enrollment in pharmacy auto-refill and home delivery services

Full Information

First Posted
October 26, 2020
Last Updated
December 29, 2021
Sponsor
Anthem, Inc
Collaborators
Apple Inc., University of California, Irvine, HealthCore, Inc., CareEvolution, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04609644
Brief Title
Asthma Digital Study
Acronym
ADS
Official Title
Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
December 21, 2022 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthem, Inc
Collaborators
Apple Inc., University of California, Irvine, HealthCore, Inc., CareEvolution, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive
Arm Type
No Intervention
Arm 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.
Arm Title
Active
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Digital Tools for Asthma Self-Management
Intervention Description
Please see description of active study arm.
Primary Outcome Measure Information:
Title
Change in asthma-associated expenditures due to emergency department and hospital utilization
Description
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.
Time Frame
12 months before and after baseline
Title
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
Description
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.
Time Frame
Baseline and 12-month time points
Secondary Outcome Measure Information:
Title
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
Description
Change from baseline among active arm participants with baseline ACT score suggesting that asthma may be uncontrolled (ACT score of 19 or lower).
Time Frame
Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Title
Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
Description
Validated PRO measure of medication adherence
Time Frame
Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Title
Readiness ruler, asthma self-management
Description
PRO measuring confidence in, and perceived importance of, asthma self-management
Time Frame
Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12
Title
Work Productivity and Activity Impairment Questionnaire 2.0, asthma version
Description
Validated PRO measure of asthma-associated work productivity impairment
Time Frame
Active arm only: Baseline and months 1, 3, 5, 8, 12
Title
Health Confidence Score
Description
Validated PRO measure of confidence in ability to manage general health
Time Frame
Active arm only: Baseline and months 1, 3, 5, 8, 12
Title
Self-reported smoking and e-cigarette use
Description
Adaptations of validated PRO measures
Time Frame
Baseline and month 12
Title
Symptom-free days
Description
Measured using Study App
Time Frame
Active arm only: Months 1-12
Title
Frequency of prescriptions for oral corticosteroids
Time Frame
Months 1-12; Months 13-24
Title
Asthma Medication Ratio
Description
For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/
Time Frame
Months 1-12; Months 13-24
Title
Adherence to asthma medications
Description
Proportion of days covered, measured using pharmacy claims
Time Frame
Months 1-12; Months 13-24
Title
Asthma-associated expenditures due to emergency department and hospital utilization
Description
Computed in the same manner as the primary outcome, except that expenditures are computed for Year 2 rather than Year 1.
Time Frame
Months 13-24
Title
Total Asthma-Associated Expenditures
Description
Total allowed costs for all care associated with asthma, including pharmacy and other costs
Time Frame
Months 1-12; Months 13-24
Title
Total Medical Expenditures
Description
Total allowed costs for all claimed healthcare expenses
Time Frame
Months 1-12; Months 13-24
Title
Frequency of unplanned visits for asthma care
Description
Includes acute primary care visits, urgent care visits, emergency visits
Time Frame
Months 1-12; Months 13-24
Title
Study App Engagement Metrics
Description
Frequencies of symptom tracking, trigger tracking, app opens
Time Frame
Active arm only: Months 1-12; Months 13-24
Title
Rates of enrollment in pharmacy auto-refill and home delivery services
Time Frame
Months 1-12; Months 13-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jordan Silberman
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36049674
Citation
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.
Results Reference
derived

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Asthma Digital Study

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