Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1500 participants
INTERVENTIONAL
2022-07-29
2024-09-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single-arm
GINA guideline education and implementation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changzhi, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dalian, , China
Research Site
Foshan, , China
Research Site
Guangzhou, , China
Research Site
Handan, , China
Research Site
Harbin, , China
Research Site
Hebi, , China
Research Site
Hefei, , China
Research Site
Huai'an, , China
Research Site
Jinan, , China
Research Site
Jinhua, , China
Research Site
Kunming, , China
Research Site
Kunshan, , China
Research Site
Nanchang, , China
Research Site
Nanning, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shiyan, , China
Research Site
Taizhou, , China
Research Site
Tianjin, , China
Research Site
Wuhu, , China
Research Site
Wuyishan, , China
Research Site
Xi'an, , China
Research Site
Yantai, , China
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D589BC00027
Identifier Type: -
Identifier Source: org_study_id
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