Impact of Multi-Component Intervention on Suspected Asthma Population

NCT ID: NCT06457009

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2026-06-30

Brief Summary

Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above.

Intervention: Within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. For study participants in the intervention arm, we will ask them to finish an online ECRHS questionnaire with notification of his or her suspected asthma status. Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL following bronchodilator administration with 400 ug salbutamol, they will be spirometry-defined undiagnosed asthma patient and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12.

Comparison: Those who are assigned in the control arm, we will ask them to finish the same ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are asthma knowledge, lung function testing, and ACT score at month 12.

Conditions

Multimorbidity; Chronic Asthma; Population Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention arm

Within the intervention arm, all medical practitioners will be incentivized by a pay-for-population mechanism within their township. First, finish a ECRHS questionnaire with notification of suspected asthma risk status. Those noticed will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population, we provide community-based spirometry PFT and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL, they will be undiagnosed asthma patients and encouraged to seek treatment to the superior hospitals. We provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with abnormal blood pressure and glucose. Intensive follow-ups will be conducted at month 3, 6, 12.

Group Type: EXPERIMENTAL

Multi-component Intervention Package

Intervention Type: COMBINATION_PRODUCT

1. Community-based spirometry pulmonary function tests and result interpretations and health education for asthma;

2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone);

3. A digital health intervention program, EmoEase, for individuals whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone);

4. Health education to smokers for smoking cessation;

5. Health education to individuals with mental health issues;

6. Encouragement to seek professional medication treatment in superior hospitals for undiagnosed asthma patients;

7. To actively include individuals whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than 11.1 mmol/L into the National Essential Public Health Service in China;

8. A CBT-based health education to the BMI abnormal, i.e., BMI > 24.0 or BMI < 18.5;

9. Pay-for-population mechanism for medical practitioners.

Control Arm

Those who are assigned in the control arm, we will ask them to finish the same ECRHS asthma screening online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component Intervention Package

1. Community-based spirometry pulmonary function tests and result interpretations and health education for asthma;

2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone);

3. A digital health intervention program, EmoEase, for individuals whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone);

4. Health education to smokers for smoking cessation;

5. Health education to individuals with mental health issues;

6. Encouragement to seek professional medication treatment in superior hospitals for undiagnosed asthma patients;

7. To actively include individuals whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than 11.1 mmol/L into the National Essential Public Health Service in China;

8. A CBT-based health education to the BMI abnormal, i.e., BMI > 24.0 or BMI < 18.5;

9. Pay-for-population mechanism for medical practitioners.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Aged 35 and above;
• Score of ECRHS asthma screening questionnaire exceeds 0;
• Residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year;
• Finished the informed consent

Exclusion Criteria

• Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
• Severe cognitive disorder or total loss of capability of daily living

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Simiao Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simiao Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Locations

Xishui County for Xishui Trial

Zunyi, Guizhou, China

Countries

China

Other Identifiers

CAMS&PUMC-IEC-2024-041

Identifier Type: -

Identifier Source: org_study_id