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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Other | GINA guideline education and implementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIP intervention | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100020 | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39778197 | Derived | 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. |
| Label | URL |
|---|---|
| D589BC00027\_Redacted CSP | View source |
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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.
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.
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.
For Pulmonologists: All participating pulmonologists from the 31 hospitals received the QIP intervention. There was no control group of pulmonologists .Baseline data were not collected for Pulmonologists. For Patients: All enrolled patients were managed by pulmonologists who had received the QIP. Patients were not randomized to different treatment strategies; the study aimed to observe the change in their outcomes before and after their physicians received the QIP.
This single-arm study assessed a hospital-level Quality Improvement Program (QIP) in 31 Chinese hospitals (29 Jul 2022 - 03 Sep 2024). The QIP was a standardized GINA 2021 guideline education intervention delivered to 282 engaged pulmonologists. Participant Population (Outcome Assessors): Consecutive asthma patients from these hospitals were screened; 1,536 were screened and 1,500 were enrolled to be managed by the trained pulmonologists.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total | Total of all participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1,362 patients were included in the FAS. All analyses were conducted based on FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | Total of all participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks. | Posted | Count of Participants | Participants | Baseline to week 48 |
|
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Adverse Event were not collected as part of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total | Total of all participants | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical project manager | AstraZeneca | 18500554074 | jiayu.ye@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2023 | Aug 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2024 | Aug 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| 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 |
| 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 |
| D589BC00027\_Redacted CSR Synopsis | View source |
| D589BC00027\_Redacted Statistical Analysis Plan | View source |
| Lost to Follow-up |
|
| Include "enrolled by mistake" and "withdrawed by mistake". |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks. | Posted | Count of Participants | Participants | Baseline to Week 48 |
|
|
|
|
| Secondary | 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 | All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks. | Posted | Count of Participants | Participants | Baseline, week 12, 24, 36 and 48 |
|
|
|
|
| Secondary | 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. | All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12, 24, 36 and 48 |
|
|
|
| Secondary | 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 | All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks. | Posted | Count of Participants | Participants | Baseline, week 12, 24 and 36 |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Difference in percentage |
| 2.1 |
| 2-Sided |
| 95 |
| 0.57 |
| 3.56 |
Change from baseline in proportion at week 24 |
| Superiority |
| Normal approximation | Difference in percentage | 12.2 | 95 | 9.25 | 15.13 | Change from baseline in proportion at week 36 | Superiority |
| Normal approximation | Difference in percentage | 13.1 | 95 | 10.32 | 15.79 | Change from baseline in proportion at week 48 | Superiority |
|
| Week 36 |
|
|
| Week 48 |
|
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Difference in percentage |
| 4.4 |
| 2-Sided |
| 95 |
| 0.61 |
| 8.23 |
Change from baseline in the proportion at week 24 |
| Superiority |
| Normal approximation | Difference in percentage | 6.5 | 2-Sided | 95 | 2.68 | 10.36 | Change from baseline in the proportion at week 36 | Superiority |