Impact of Multi-Component Interventions on High Risk COPD Population (POPMIX-COPD)

Peking Union Medical College

Status: Active, not recruiting

Conditions: Population Medicine; Multimorbidity; Chronic Obstructive Pulmonary Disease

Treatments: Combination Product: Multi-component intervention package

Study type: Interventional

Funder types: Other

Identifiers

NCT06456996

CAMS&PUMC-IEC-2024-040

Details and patient eligibility

About

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.

Enrollment: 7,400 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,400 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Combination Product: Multi-component intervention package

Control Arm

No Intervention group

Description:

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.