CClinicalTrials.gg
CompletedNCT02761837Updated Nov 9, 2023

The Breathe Well Program for Adults With Asthma

An interventional study of IVR call/text and Email in Asthma, sponsored by National Jewish Health. Completed at 1 site in United States. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by National Jewish Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
14,978
Allocation
Randomized
Ages
19 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

Breathe Well uses the Kaiser Permanente Electronic Health Record (EHR) to identify asthma exacerbation risk factors. For patients with a history of frequent exacerbations or B-agonist overuse, the EHR notifies a nurse who uses an EHR-generated tailored clinical report and patient directed decision support tool to engage and empower patients to develop an action plan in collaboration with providers. EHR-templated notes and order sets facilitate care plan execution. Poor controller medication adherence or unaddressed smoking results in the patient being automatically enrolled in an IBCT medication refill or smoking cessation program. Breathe Well uses multiple EHR functions and a patient and provider team to address barriers to evidence-based asthma care for providers.The study will be conducted in 26 primary care clinics of Kaiser Permanente Colorado (KPCO) using a pragmatic clinical trial design. Up to 15,000 high-risk asthma patients will be assigned to Breathe Well or guideline-based usual care based on their clinic.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 14,978 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

National Jewish Health is the lead sponsor of 108 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Adults with ≥1 EHR of these indicators of an asthma care gap in the EHR will be eligible.

  1. B-agonist overfilling
  2. inhaled corticosteroid (ICS) underfilling
  3. current smoker
  4. asthma exacerbation in the last year

Exclusion Criteria:

  1. limited life expectancy
  2. diagnosis of chronic obstructive pulmonary disease
  3. lack of a pharmacy benefit because medication use cannot be captured.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14,978 participants (actual)

Study arms

  • Active comparator
    IVR call/text

    Identify gaps in care and contact patients by IVR phone call or text

    Behavioral: IVR call/text

  • Active comparator
    Email

    Identify gaps in care and contact patients by email

    Behavioral: Email

Interventions

  • BehavioralIVR call/text

    For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text

  • BehavioralEmail

    Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email

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What researchers measure

Primary outcomes

  1. Asthma Exacerbations

    Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid

    Time frame: 12 months

Secondary outcomes

  1. Controller medication adherence

    Days of medication possession will be calculated for each patient

    Time frame: 12 months

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Study locations

1 site
  • Kaiser Permanente of Colorado
    Denver, Colorado 80231, United States
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References and documents

Publications

  • Cvietusa 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. PubMed 33635779 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02761837
Lead sponsor
National Jewish Health
Collaborators
Kaiser Permanente
Responsible party
Sponsor
First posted
May 4, 2016
Start date
Oct 2016
Primary completion
Jun 2023
Completion
Jun 2023
Last update
Nov 9, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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