Impact of Multi-Component Interventions on High Risk COPD Population

NCT ID: NCT06456996

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: High-risk COPD population, defined as individuals whose score of COPD-SQ is 16 and above and whose age is 35 and above. COPD-SQ questionnaire will be assigned to a representative sample of local residents in Xishui County, and they will finish the questionnaire online through mobile phone.

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 COPD-SQ questionnaire with notification of his or her COPD high risk status. Those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC<0.7, they will be spirometry-defined COPD patients 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 COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are COPD knowledge, COPD screening, and FEV1 measurement at month 12.

Conditions

Multimorbidity; Population Medicine; Chronic Obstructive Pulmonary Disease

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 under a pay-for-population mechanism to incentivize them to care for the overall population health within their township. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients 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.

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 COPD;

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 spirometry-defined COPD patients;

7. To actively include individuals whose blood pressurei 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 COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given at baseline. However, at month 12, we will provide community-based pulmonary function tests and physical examinations besides face-to-face survey.

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 COPD;

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 spirometry-defined COPD patients;

7. To actively include individuals whose blood pressurei 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;
• COPD-SQ score is 16 and above;
• 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

Peking Union Medical College

OTHER

Sponsor Role: lead

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Responsible Party

Simiao Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simiao Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Locations

26 township hospitals in Xishui County

Zunyi, Guizhou, China

Countries

China

Other Identifiers

CAMS&PUMC-IEC-2024-040

Identifier Type: -

Identifier Source: org_study_id