Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Asthma Digital Study (ADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04609644
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : January 3, 2022
Sponsor:
Collaborators:
Apple Inc.
University of California, Irvine
HealthCore, Inc.
CareEvolution, LLC
Information provided by (Responsible Party):
Anthem, Inc

Tracking Information
First Submitted Date  ICMJE October 26, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date January 3, 2022
Actual Study Start Date  ICMJE October 30, 2020
Estimated Primary Completion Date December 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
Asthma-associated expenditures due to emergency department and hospital utilization [ Time Frame: Months 1-12 ]
Sum of all allowed costs for emergency and hospital care, where asthma is specified as a diagnosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • 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 ]
    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) [ Time Frame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12 ]
    Validated PRO measure of medication adherence
  • Readiness ruler, asthma self-management [ Time Frame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12 ]
    PRO measuring confidence in, and perceived importance of, asthma self-management
  • Work Productivity and Activity Impairment Questionnaire 2.0, asthma version [ Time Frame: Active arm only: Baseline and months 1, 3, 5, 8, 12 ]
    Validated PRO measure of asthma-associated work productivity impairment
  • Health Confidence Score [ Time Frame: Active arm only: Baseline and months 1, 3, 5, 8, 12 ]
    Validated PRO measure of confidence in ability to manage general health
  • Self-reported smoking and e-cigarette use [ Time Frame: Baseline and month 12 ]
    Adaptations of validated PRO measures
  • Symptom-free days [ Time Frame: Active arm only: Months 1-12 ]
    Measured using Study App
  • 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 ]
    For details see: www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/
  • Adherence to asthma medications [ Time Frame: Months 1-12; Months 13-24 ]
    Proportion of days covered, measured using pharmacy claims
  • Asthma-associated expenditures due to emergency department and hospital utilization [ Time Frame: Months 13-24 ]
    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 [ Time Frame: Months 1-12; Months 13-24 ]
    Total allowed costs for all care associated with asthma, including pharmacy and other costs
  • Total Medical Expenditures [ Time Frame: Months 1-12; Months 13-24 ]
    Total allowed costs for all claimed healthcare expenses
  • Frequency of unplanned visits for asthma care [ Time Frame: Months 1-12; Months 13-24 ]
    Includes acute primary care visits, urgent care visits, emergency visits
  • Study App Engagement Metrics [ Time Frame: Active arm only: Months 1-12; Months 13-24 ]
    Frequencies of symptom tracking, trigger tracking, app opens
  • Rates of enrollment in pharmacy auto-refill and home delivery services [ Time Frame: Months 1-12; Months 13-24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Asthma Control Test [ Time Frame: Active arm: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12; Passive arm: Baseline and month 12 ]
    Validated patient-reported outcome (PRO) measure of asthma symptom control
  • 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 ]
    Validated PRO measure of medication adherence
  • Readiness ruler, asthma self-management [ Time Frame: Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12 ]
    PRO measuring confidence in, and perceived importance of, asthma self-management
  • Work Productivity and Activity Impairment Questionnaire 2.0, asthma version [ Time Frame: Active arm only: Baseline and months 1, 3, 5, 8, 12 ]
    Validated PRO measure of asthma-associated work productivity impairment
  • Health Confidence Score [ Time Frame: Active arm only: Baseline and months 1, 3, 5, 8, 12 ]
    Validated PRO measure of confidence in ability to manage general health
  • Self-reported smoking and vaping [ Time Frame: Baseline and month 12 ]
    Adaptations of validated PRO measures
  • Symptom-free days [ Time Frame: Active arm only: Months 1-12 ]
    Measured using Study App
  • 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 ]
    For details see: https://www.ncqa.org/hedis/measures/medication-management-for-people-with-asthma-and-asthma-medication-ratio/
  • Adherence to asthma medications [ Time Frame: Months 1-12; Months 13-24 ]
    Proportion of days covered, measured using pharmacy claims
  • Asthma-associated expenditures due to emergency department and hospital utilization [ Time Frame: Months 13-24 ]
    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 [ Time Frame: Months 1-12; Months 13-24 ]
    Total allowed costs for all care associated with asthma, including pharmacy and other costs
  • Total Medical Expenditures [ Time Frame: Months 1-12; Months 13-24 ]
    Total allowed costs for all claimed healthcare expenses
  • Frequency of unplanned visits for asthma care [ Time Frame: Months 1-12; Months 13-24 ]
    Includes acute primary care visits, urgent care visits, emergency visits
  • Study App Engagement Metrics [ Time Frame: Active arm only: Months 1-12; Months 13-24 ]
    Frequencies of symptom tracking, trigger tracking, app opens
  • Rates of enrollment in pharmacy auto-refill and home delivery services [ Time Frame: Months 1-12; Months 13-24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asthma Digital Study
Official Title  ICMJE Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Asthma
Intervention  ICMJE Other: Digital Tools for Asthma Self-Management
Please see description of active study arm.
Study Arms  ICMJE
  • No Intervention: Passive

    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.

  • Experimental: Active

    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: Other: Digital Tools for Asthma Self-Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 8, 2021)
901
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2020)
900
Estimated Study Completion Date  ICMJE December 21, 2023
Estimated Primary Completion Date December 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04609644
Other Study ID Numbers  ICMJE HS# 2020-5711
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anthem, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Anthem, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Apple Inc.
  • University of California, Irvine
  • HealthCore, Inc.
  • CareEvolution, LLC
Investigators  ICMJE Not Provided
PRS Account Anthem, Inc
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP