CARE FOR ALL：an Evaluation of an Asthma QIP
CARE FOR ALL
Change Asthma Clinical Practice Through Guideline Education and Implementation For All Patients With Asthma: an Evaluation of an Asthma Quality Improvement Program
1 other identifier
interventional
1,500
1 country
32
Brief Summary
This is an evaluation on an asthma Quality Improvement Program (QIP, including GINA guideline education/training and implementation) to understand the change of physician behaviours, which leads to the change of patient outcomes. Primary endpoint is "Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48 ". A total of around 30 eligible Tier 3 and Tier 2 hospitals will be selected across China. Approximately 1500 eligible asthmatic patients fulfilling the following inclusion and exclusion criteria will be enrolled consecutively from participating hospitals,. The QIP (including GINA guideline education/training and implementation) will be delivered at the hospital level, targeting all pulmonologists and specialist nurses at participating hospitals, including initial comprehensive education, reinforcement learning, and performance assessment and feedback of pulmonologists' guideline implementation, along with multiple online and offline approaches serving as reminders and supportive tools to ensure consistent education and to facilitate the asthma management in routine clinical practice in accordance with GINA recommendation. After the initiation of the intervention program participating patients will return to the study hospital every 12 weeks for on-site follow-up visits (V1 to V5), in accordance with guideline recommendations. Meanwhile, investigators are mandatory requested to join in reinforce education at regular time. Guideline implementation performance will be assessed against with multi-approach indicators for each participant's offline or online visit. The objective of the CARE FOR ALL study is to bridge the gap that exists between the recommendations from GINA 2021 and current clinical practice by demonstrating the benefits of an asthma quality improvement program (QIP), i.e. a standardized pulmonologist-targeted GINA guideline education and practice implementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jul 2022
Typical duration for phase_4 asthma
32 active sites
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
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2024
CompletedResults Posted
Study results publicly available
January 2, 2026
CompletedJanuary 2, 2026
December 1, 2025
2.1 years
June 2, 2022
August 13, 2025
December 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment
Change from baseline in the proportion of patients with an ICS-based maintenance and/or reliever treatment at week 48 was performed using mixed effect logistic regression model.
Baseline to week 48
Secondary Outcomes (4)
Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48
Baseline to Week 48
Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48
Baseline, week 12, 24, 36 and 48
Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48
Baseline, week 12, 24, 36 and 48
Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36
Baseline, week 12, 24 and 36
Study Arms (1)
single-arm
OTHERGINA guideline education and implementation
Interventions
The QIP includes pulmonologist-targeted guideline education and guideline implementation. Guideline education includes the initial comprehensive training and reinforcement learning. The initial comprehensive education will be delivered at each participating hospital by a dedicated national asthma expert team, immediately after last patient enrolled at each site. The PI of respiratory departments from participating hospitals are responsible for arranging the delivery of hospital-level reinforcement learnings and ensuring the quality and success of hospital-level guideline implementation. The pulmonologists' guideline adherence and performance at participating hospitals will be regularly assessed during the study period.
Eligibility Criteria
You may qualify if:
- Participant must be 14 years of age or older at the time of signing the informed consent.
- Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g. from bronchodilator reversibility testing or other test)
- Participating patients and/or their legally authorised representative must provide signed and dated written informed consent form prior to any study specific procedures.
You may not qualify if:
- Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma
- Any significant disease or disorder (e.g. cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
- Disease or condition other than asthma that requires treatment with systemic or oral steroids
- Participation in another clinical study with an Investigational Product administered in the last 3 months prior to Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Beijing, 100020, China
Research Site
Beijing, 100050, China
Research Site
Beijing, 100080, China
Research Site
Changchun, 130033, China
Research Site
Changsha, 410005, China
Research Site
Changzhi, 046000, China
Research Site
Chengdu, 610021, China
Research Site
Chongqing, 404197, China
Research Site
Dalian, 116011, China
Research Site
Foshan, 528315, China
Research Site
Guangzhou, 510620, China
Research Site
Handan, 056000, China
Research Site
Harbin, 150001, China
Research Site
Hebi, 458000, China
Research Site
Hefei, 230011, China
Research Site
Huai'an, 223000, China
Research Site
Jinan, 250031, China
Research Site
Jinhua, 322100, China
Research Site
Kunming, 650051, China
Research Site
Kunshan, 215316, China
Research Site
Nanchang, 331700, China
Research Site
Nanning, China
Research Site
Ningbo, 315040, China
Research Site
Shanghai, 200030, China
Research Site
Shanghai, 200080, China
Research Site
Shiyan, 442005, China
Research Site
Taizhou, 317100, China
Research Site
Tianjin, 300450, China
Research Site
Wuhu, 241000, China
Research Site
Wuyishan, 354300, China
Research Site
Xi'an, 710038, China
Research Site
Yantai, 265701, China
Related Publications (1)
Huang K, Wang W, Wang Y, Li Y, Feng X, Shen H, Wang C. Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study. JMIR Res Protoc. 2025 Jan 8;14:e65197. doi: 10.2196/65197.
PMID: 39778197DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The Institution shall own all rights and title in and to the StudyDocumentation. Inacknowledgment of the contribution made by AstraZeneca to the Study, the Institution shall disclose all or any portion of the Study Documentation to AstraZeneca on request, and shall permit AstraZeneca to use the disclosed Study Documentation for any purpose.
Results Point of Contact
- Title
- Clinical project manager
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 30, 2022
Study Start
July 29, 2022
Primary Completion
September 3, 2024
Study Completion
September 3, 2024
Last Updated
January 2, 2026
Results First Posted
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.