The Breathe Well Program for Adults With Asthma
The Breathe Well Program to Improve Asthma Outcomes
1 other identifier
interventional
14,978
1 country
1
Brief Summary
The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness, cost-effectiveness, and implementation of the Breathe Well intervention, which combines evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to improve asthma outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Oct 2016
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedNovember 9, 2023
November 1, 2023
6.7 years
April 28, 2016
November 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Asthma Exacerbations
Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid
12 months
Secondary Outcomes (1)
Controller medication adherence
12 months
Study Arms (2)
IVR call/text
ACTIVE COMPARATORIdentify gaps in care and contact patients by IVR phone call or text
Identify gaps in care and contact patients by email
Interventions
For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text
Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email
Eligibility Criteria
You may qualify if:
- B-agonist overfilling
- inhaled corticosteroid (ICS) underfilling
- current smoker
- asthma exacerbation in the last year
You may not qualify if:
- limited life expectancy
- diagnosis of chronic obstructive pulmonary disease
- lack of a pharmacy benefit because medication use cannot be captured.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Kaiser Permanentecollaborator
Study Sites (1)
Kaiser Permanente of Colorado
Denver, Colorado, 80231, United States
Related Publications (2)
Bender BG, Cvietusa PJ, Goodrich GK, King DK, Shoup JA. Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention. Transl Behav Med. 2023 Apr 3;13(3):149-155. doi: 10.1093/tbm/ibac093.
PMID: 36689336DERIVEDCvietusa PJ, Wagner NM, Shoup JA, Goodrich GK, Shetterly SM, King DK, Raebel MA, Riggs CS, Bender B. Digital Communication Technology: Does Offering a Choice of Modality Improve Medication Adherence and Outcomes in a Persistent Asthma Population? Perm J. 2020 Dec;25:1. doi: 10.7812/TPP/20.189.
PMID: 33635779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is a pragmatic controlled trial. Participants randomized to the intervention group will know when they receive the intervention, which will consist of an automated contact by IVR call/text, or email.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 4, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
November 9, 2023
Record last verified: 2023-11