Clinical trial NCT05440097: CARE FOR ALL：an Evaluation of an Asthma QIP
Official title: Change Asthma Clinical Practice Through Guideline Education and Implementation For All Patients With Asthma: an Evaluation of an Asthma Quality Improvement Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the change in GINA guideline-recommended treatment after guideline education and implementation
timeFrame: 48 weeks
Secondary outcomes:
measure: To describe the asthma control after guideline education and implementation.
timeFrame: 48 weeks
measure: To describe the change in GINA guideline-preferred treatments during guideline education and implementation.
timeFrame: 48 weeks
measure: To describe the change in asthma control during guideline education and implementation.
timeFrame: 48 weeks
measure: To describe the change in GINA guideline-recommended treatments during guideline education and implementation.
timeFrame: 36 weeks
measure: To describe asthma related treatment patterns during the study duration.
timeFrame: 48 Weeks
Other outcomes:
measure: To explore the guideline implementation performance during guideline education and implementation
timeFrame: 48 weeks
measure: To explore hospitalization due to asthma exacerbation during guideline education and implementation
timeFrame: 48 weeks
measure: To explore severe asthma exacerbation numbers during guideline education and implementation.
timeFrame: 48 weeks
measure: To explore health-related quality of life in patients with asthma after guideline education and implementation.
timeFrame: 48 weeks
measure: To evaluate the actual treatment change in GINA guideline-recommended treatments after guideline education and implementation
timeFrame: 48 weeks
measure: To explore adherence change in GINA guideline-recommended treatments after guideline education and implementation.
timeFrame: 48 weeks
measure: To explore change in inhales skills score after guideline education and implementation.
timeFrame: 48 weeks
measure: To describe consistency between patient self-assessment and GINA-evaluated asthma severity level
timeFrame: 0 week
measure: To explore relationship between baseline characteristic and asthma control level
timeFrame: 48 weeks
measure: To explore relationship between subject characteristics and the related symptoms after COVID-19 infection
timeFrame: 48 weeks
measure: To explore change in knowledge questionnaire after guideline education and implementation.
timeFrame: 48 weeks
measure: To explore change in patient expectation of asthma treatment after guideline education and implementation.
timeFrame: 48 weeks
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changzhi
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Handan
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hebi
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Huai'an
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jinhua
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Kunshan
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shiyan
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhu
country: China
facility: Research Site
city: Wuyishan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Yantai
country: China
facility: Research Site
Study officials:
References: