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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: QIP intervention

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Research Site
  • Beijing, China, 100050
    • Research Site
  • Beijing, China, 100080
    • Research Site
  • Changchun, China, 130033
    • Research Site
  • Changsha, China, 410005
    • Research Site
  • Changzhi, China, 046000
    • Research Site
  • Chengdu, China, 610021
    • Research Site
  • Chongqing, China, 404197
    • Research Site
  • Dalian, China, 116011
    • Research Site
  • Foshan, China, 528315
    • Research Site
  • Guangzhou, China, 510620
    • Research Site
  • Handan, China, 056000
    • Research Site
  • Harbin, China, 150001
    • Research Site
  • Hebi, China, 458000
    • Research Site
  • Hefei, China, 230011
    • Research Site
  • Huai'an, China, 223000
    • Research Site
  • Jinan, China, 250031
    • Research Site
  • Jinhua, China, 322100
    • Research Site
  • Kunming, China, 650051
    • Research Site
  • Kunshan, China, 215316
    • Research Site
  • Nanchang, China, 331700
    • Research Site
  • Nanning, China
    • Research Site
  • Ningbo, China, 315040
    • Research Site
  • Shanghai, China, 200080
    • Research Site
  • Shanghai, China, 200030
    • Research Site
  • Shiyan, China, 442005
    • Research Site
  • Taizhou, China, 317100
    • Research Site
  • Tianjin, China, 300450
    • Research Site
  • Wuhu, China, 241000
    • Research Site
  • Wuyishan, China, 354300
    • Research Site
  • Xi'an, China, 710038
    • Research Site
  • Yantai, China, 265701
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant must be 14 years of age or older at the time of signing the informed consent.
2. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g. from bronchodilator reversibility testing or other test)
3. Participating patients and/or their legally authorised representative must provide signed and dated written informed consent form prior to any study specific procedures.

Exclusion Criteria:

1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma
2. 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
3. Disease or condition other than asthma that requires treatment with systemic or oral steroids
4. Participation in another clinical study with an Investigational Product administered in the last 3 months prior to Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single-arm; GINA guideline education and implementation

Other: QIP intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48	The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. Mean scores of ≤0.75 indicate well controlled asthma, 0.75-1.5 indicate partly controlled asthma, and ≥1.5 indicates not well controlled asthma.	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	The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore severe asthma exacerbation numbers during guideline education and implementation.	Numbers of severe asthma exacerbation at baseline, weeks 12, 24, 36 and 48	48 weeks
To explore the guideline implementation performance during guideline education and implementation	The proportion of patients whose pulmonologists develop or review the written asthma action plan at weeks 0, 12, 24, 36 and 48 The proportion of patients whose pulmonologists watch the patient using their inhaler, educate their technique at weeks 0, 12, 24, 36 and 48	48 weeks
To explore hospitalization due to asthma exacerbation during guideline education and implementation	Annualized rate of hospitalization due to asthma exacerbations per patient	48 weeks
To explore health-related quality of life in patients with asthma after guideline education and implementation.	The Asthma Quality of Life Questionnaire (+12)( AQLQ(S)+12) is a 7-point scale, The minimum average score of is 1,the maximum average score is 7, (7 = not impaired at all,1 = severely impaired), with higher scores indicating better quality of life. Change from baseline in health-related quality of life evaluated by Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) average score at week 0, 12, 24, 36 and 48	48 weeks
To evaluate the actual treatment change in GINA guideline-recommended treatments after guideline education and implementation	Change from baseline in the proportion of patients with an ICS-based maintenance and/or reliever actual treatment at week 48	48 weeks
To explore adherence change in GINA guideline-recommended treatments after guideline education and implementation.	Medication Adherence Report Scale for Asthma(MARS-A) is a 5-point scale, The minimum average score of is 1,the maximum average score is 5 .The higher the score, the better the adherence. Change from baseline in MARS-A average score at week 12, 24, and 48	48 weeks
To explore change in inhales skills score after guideline education and implementation.	Use Inhaler skill score assessment checklist to evaluate inhaler skill. (Minimum to maximum average score 0-7). The higher the score, the better the skill. Change from baseline by inhaler skills score of investigators at week 12, 24 and 48; Change from baseline by inhaler skills score of subjects at week 12, 24 and 48	48 weeks
To describe consistency between patient self-assessment and GINA-evaluated asthma severity level	Describe consistency of patient self-assessment and GINA-evaluated asthma severity level. Patient self assessment used one question for respondents to classify asthma severity by 3 choices: mild, moderate, severity.	0 week
To explore relationship between baseline characteristic and asthma control level	The asthma control level is assessed by Asthma Control Questionnaire-5 (ACQ-5), and the control level is divided based on average scores, e.g. well-controlled (ACQ-5 ≤ 0.75), partially controlled (0.75 to 1.5) and not well-controlled (ACQ-5 ≥ 1.5)], baseline characteristic include demographics characters, education level, Hospital level, medication regime etc. Asthma control level of baseline, week 0, 12, 24, 36 and 48	48 weeks
To explore relationship between subject characteristics and the related symptoms after COVID-19 infection	Use the COVID-19 Infection Cough Characteristics and Prognosis Survey Version 1.0" (released in January 2023) to collect the patients' covid-19 related symptoms, etc.And compare it with ACQ-5 etc. to see whether there is a relationship.	48 weeks
To explore change in knowledge questionnaire after guideline education and implementation.	Use Disease Knowledge Questionnaire for Asthma Patients to evaluate asthma education, (Minimum to maximum average score 0-25). The higher the score, the better the education. Change from baseline by asthma knowledge questionnaire score of subjects at week 12, 24 and 48 Change from baseline by asthma knowledge questionnaire score of investigators at week 12, 24 and 48	48 weeks
To explore change in patient expectation of asthma treatment after guideline education and implementation.	Patient's expectation for asthma treatment Questionnaire has 14 items, (Minimum to maximum average score 0-10). The higher the score, the more important the item is. Change from baseline by patient expectation of asthma treatment of subjects at week 12, 24, and 48	48 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• D589BC00027_Redacted CSP
• D589BC00027_Redacted CSR Synopsis
• D589BC00027_Redacted Statistical Analysis Plan

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D589BC00027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No