N/A
N=857
US PRECISION Implementation Study
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04891978 ↗Enrolled (actual)
857
Serious AEs
—
Results posted
Jul 2025
Primary outcome: Primary: Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice. — 1; 3; 1; 5 Sites
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AIRQ (Behavioral); Asthma Checklist (Behavioral); PRECISION Program (Educational Resources) (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice. |
1; 3; 1; 5; 4; 2 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to How Much the AIRQ Helped Manage Patients |
5; 0; 0; 5; 1; 5 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Whether the AIRQ Helped Identify Patients at Risk for Adverse Asthma Health Outcomes |
5; 3; 1; 9; 1; 3 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Most and Least Helpful Parts of AIRQ |
4; 1; 1; 6; 2; 0 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Frequency of Referring to a Specialist or Practice Type Different Than Their Own While Using the AIRQ |
2; 6; 1; 9; 4; 0 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Components of Care Improved by AIRQ |
4; 4; 1; 9; 5; 1 | — |
| PRIMARY Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Importance of Using Different Components of the PRECISION Program |
4; 0; 0; 4; 2; 5 | — |
| PRIMARY Average Number of Patients Treated Using the PRECISION Program at Each Site as Reported by Site HCPs by Site Type |
72.2; 46.2; 130.0; 64.6 | — |
| PRIMARY Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Primary Care Sites |
2; 2; 2; 1; 1; 2 | — |
| PRIMARY Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Specialty Care Sites |
3; 2; 1; 1; 3; 1 | — |
| PRIMARY Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Novel Care Site |
1; 1 | — |
| PRIMARY Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites |
4; 3; 3; 4; 3; 1 | — |
| PRIMARY Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites |
2; 2; 1; 1; 1; 4 | — |
| PRIMARY Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites |
6; 4; 3; 2; 2; 1 | — |
| PRIMARY Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Descriptive Free-text HCP Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site |
1; 1; 1 | — |
| PRIMARY Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 1) |
2; 1; 1; 2; 1; 1 | — |
| PRIMARY Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 2) |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Specialty Care Sites (Month 1) |
2; 1; 1; 1; 1; 1 | — |
| PRIMARY Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Novel Care Site (Month 2) |
0; 1; 1; 1; 1; 1 | — |
| SECONDARY Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean and Standard Deviation at Each Visit |
1.8; 4.2; 4.5; 1.1; 3.1; 2.8 | — |
| SECONDARY Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean Difference and Confidence Interval |
-0.7; -1.1; -1.7 | — |
| SECONDARY Change in Patient AIRQ Control Level From Baseline to Follow-up Visit |
75; 23; 20; 4; 0; 2 | — |
| SECONDARY Percentage of Endorsement of Responses for Each of the 8 Categorical Items on the ACE Questionnaire |
26; 7; 6; 29; 17; 2 | — |
Summary
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits.
The secondary objectives are to assess asthma patients' clinic visit experiences when the AIRQ, the Asthma Checklist, and educational resources (PRECISION program) are utilized as part of a telehealth or in-person visit with their HCP, and to explore change in AIRQ scores from the initial visit to follow-up visit(s) (when available).
Eligibility Criteria
Inclusion Criteria
- >= 13 years of age at the time of enrollment
- Diagnosis of HCP-confirmed asthma
- Able to read, understand and speak English or Spanish sufficiently self-complete or be administered the AIRQ via telephone, desktop, or mobile device (e.g., smartphone, iPad)
- Provide consent (adults/parents/guardians) and assent (age 13-17 years) to participate in the study.
Exclusion Criteria
- Current diagnosis of active COPD or any lower respiratory diagnosis other than asthma
- Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English or Spanish language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the AIRQ or other study questionnaires
Data sourced from ClinicalTrials.gov (NCT04891978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.