Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456996
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-07
Brief Title:
Impact of Multi-Component Interventions on High Risk COPD Population
Sponsor:
Peking Union Medical College
Organization:
Peking Union Medical College
Study Overview
Official Title:
Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population A Cluster Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPMIX-COPD
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 FEV1FVC07 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
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 FEV1FVC07 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None