CARE FOR ALL：an Evaluation of an Asthma QIP
- Conditions
- Asthma
- Interventions
- Other: QIP intervention
- Registration Number
- NCT05440097
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single-arm QIP intervention GINA guideline education and implementation
- Primary Outcome Measures
Name Time Method To evaluate the change in GINA guideline-recommended treatment after guideline education and implementation 48 weeks Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48
- Secondary Outcome Measures
Name Time Method To describe the change in GINA guideline-preferred treatments during guideline education and implementation. 48 weeks Change from baseline in the proportion of participants on the treatment of ICS-formoterol as reliever at week 12, 24, 36 and 48
To describe the change in GINA guideline-recommended treatments during guideline education and implementation. 36 weeks Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 12, 24 and 36
To describe the change in asthma control during guideline education and implementation. 48 weeks The Asthma Control Questionnaire-5 (ACQ-5) is a 7-point scale, the minimum average score is 0, the maximum average score is 6 (0=no impairment, 6= maximum impairment for symptoms and rescue use), with higher scores indicating worse asthma control.
Change from baseline in ACQ-5 average score at week 12, 24, 36 and 48 Change from baseline in the proportion of participants achieving an improvement in ACQ-5 MCID of 0.5 units or more at week 12, 24, 36 and 48To describe asthma related treatment patterns during the study duration. 48 Weeks Asthma related treatment patterns Asthma treatment distribution at baseline and weeks 12, 24, 36, and 48, e.g., ICS-containing medications, ICS-LABA, ICS-formoterol, oral corticosteroids, leukotriene receptor antagonists, theophylline, Traditional Chinese Medicine
To describe the asthma control after guideline education and implementation. 48 weeks Change from baseline in the proportion of participant with well-controlled asthma (ACQ-5 ≤ 0.75) at week 48; Distribution of ACQ-5 average scores \[proportion of subjects well-controlled (ACQ-5 ≤ 0.75), partially controlled (0.75 to 1.5) and not well-controlled (ACQ-5 ≥ 1.5)\] at week 12, 24, 36 and 48
Trial Locations
- Locations (1)
Research Site
🇨🇳Yantai, China