Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-09
Brief Title:
Impact of Multi-Component Interventions on High-Risk COPD Smokers
Sponsor:
Peking Union Medical College
Organization:
Peking Union Medical College
Study Overview
Official Title:
Population Medicine Multimorbidity Interventions in Xishui on High-risk COPD Smokers 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-Smoking
Brief Summary:
Study Participants In our study we focus on smokers who self-report a current smoking status or smoking cessation less than 6 months This trial is a sub-trial of Impact of Multi-Component Interventions on a High-Risk COPD population Protocol ID CAMSPUMC-IEC-2024-040 All smokers in this trial are either from the high-risk COPD population defined by COPD-SQ score16
Intervention 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 For those whose score of COPD-SQ 16 we will provide a face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For smokers in the intervention arm we provide a digital health intervention program NicQuit to whom could familiarly use intelligent mobile phones and health education for all smokers We also provide community-based spirometry pulmonary function test PFT and education to smokers If smokers 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 another digital health intervention programs to smokers 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 self-reported average number of cigarettes consumed per day smoking dependence index and CO measurement
Intervention 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 For those whose score of COPD-SQ 16 we will provide a face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For smokers in the intervention arm we provide a digital health intervention program NicQuit to whom could familiarly use intelligent mobile phones and health education for all smokers We also provide community-based spirometry pulmonary function test PFT and education to smokers If smokers 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 another digital health intervention programs to smokers 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 self-reported average number of cigarettes consumed per day smoking dependence index and CO measurement
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