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ACTIVE NOT RECRUITING
NCT06456996
NA

Impact of Multi-Component Interventions on High Risk COPD Population

Sponsor: Peking Union Medical College

View on ClinicalTrials.gov

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.

Official title: Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population: A Cluster Randomized Controlled Trial

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7400

Start Date

2024-06-17

Completion Date

2026-06-30

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

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.

Locations (1)

26 township hospitals in Xishui County

Zunyi, Guizhou, China