Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457009
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-07
Brief Title:
Impact of Multi-Component Intervention on Suspected Asthma Population
Sponsor:
Peking Union Medical College
Organization:
Peking Union Medical College
Study Overview
Official Title:
Population Medicine Multimorbidity Intervention in Xishui on a Suspected Asthma 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-Asthma
Brief Summary:
Study Participants Suspected asthma population defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above
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 ECRHS questionnaire with notification of his or her suspected asthma status Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For suspected asthma population in the intervention arm we provide community-based spirometry pulmonary function test PFT and education If individuals whose FEV1 improved by 12 and 200 mL following bronchodilator administration with 400 ug salbutamol they will be spirometry-defined undiagnosed asthma patient 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 ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey No physical examinations community-based pulmonary function tests will be given
Outcomes The primary outcomes are asthma knowledge lung function testing and ACT score 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 ECRHS questionnaire with notification of his or her suspected asthma status Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey simple physical examination pulmonary function tests and provide a multi-component intervention at baseline For suspected asthma population in the intervention arm we provide community-based spirometry pulmonary function test PFT and education If individuals whose FEV1 improved by 12 and 200 mL following bronchodilator administration with 400 ug salbutamol they will be spirometry-defined undiagnosed asthma patient 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 ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey No physical examinations community-based pulmonary function tests will be given
Outcomes The primary outcomes are asthma knowledge lung function testing and ACT 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