Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-09
Brief Title:
Impact of Multi-component Interventions on Populations With Mental Health Symptoms and High-risk COPD
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 With Mental Health Symptoms 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-MH
Brief Summary:
Study Participants High-risk COPD population with mental health symptoms defined as individuals whose score of COPD-SQ 16 whose age is 35 and above and whose Warwick-Edinburgh Mental Well-being Scale 45
Intervention We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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 For those with high-risk COPD population we will provide face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For high-risk COPD population with mental health issues 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 A CBT-based digital health intervention program EmoEase will be provided to our study participants with an intelligent mobile phone Also health education in terms of mental health issues will be given Additionally we provide 1 a digital health intervention programs to smokers 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 PHQ-9 scores for depression symptoms GAD-7 symptoms for anxiety symptoms and WEM-WBS score at month 12
Intervention We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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 For those with high-risk COPD population we will provide face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For high-risk COPD population with mental health issues 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 A CBT-based digital health intervention program EmoEase will be provided to our study participants with an intelligent mobile phone Also health education in terms of mental health issues will be given Additionally we provide 1 a digital health intervention programs to smokers 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 PHQ-9 scores for depression symptoms GAD-7 symptoms for anxiety symptoms and WEM-WBS score 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