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NCT06456996Completed

Impact of Multi-Component Interventions on High Risk COPD Population

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

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
9319 (actual)
First submitted
7 Jun 2024
Start date
17 Jun 2024
Primary completion date
31 Mar 2026
Lead sponsor
Peking Union Medical College
Diseases
COPD
NCT number
NCT06456996

What you commit to

  • Study type: Interventional
  • Participants enrolled: 9319
  • From 17 Jun 2024 to the primary completion date, 31 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
26 township hospitals in Xishui County
Coordinator of this site? Confirm its status
ZunyiChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.