CARE FOR ALL：an Evaluation of an Asthma QIP

Asthma Clinical Trial

— CARE FOR ALL  

Official title:

Change Asthma Clinical Practice Through Guideline Education and Implementation For All Patients With Asthma: an Evaluation of an Asthma Quality Improvement Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05440097
• Other study ID #: D589BC00027
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: June 28, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	To explore hospitalization due to asthma exacerbation during guideline education and implementation	Annualized rate of hospitalization due to asthma exacerbations per patient	48 weeks
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	To evaluate the change in GINA guideline-recommended treatment after guideline education and implementation	Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48	48 weeks
Secondary	To describe the asthma control after guideline education and implementation.	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	48 weeks
Secondary	To describe the change in GINA guideline-preferred treatments during guideline education and implementation.	Change from baseline in the proportion of participants on the treatment of ICS-formoterol as reliever at week 12, 24, 36 and 48	48 weeks
Secondary	To describe the change in asthma control during guideline education and implementation.	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 48	48 weeks
Secondary	To describe the change in GINA guideline-recommended treatments during guideline education and implementation.	Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 12, 24 and 36	36 weeks
Secondary	To describe asthma related treatment patterns during the study duration.	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	48 Weeks