Impact of Multi-Component Interventions on High Risk COPD Population

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: Impact of a Multi-Component Intervention on a High-Risk COPD Population: A Cluster Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Multimorbidity
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT06456996
• Study type: Interventional
• Source: Peking Union Medical College
• Contact: Simiao Chen, Ph.D.
• Phone: 010-65104915
• Email: simiao.chen@uni-heidelberg.de
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Completion date: October 1, 2025