Clinical trial NCT06350305: Screening for High-risk Chronic Obstructive Pulmonary Disease
Official title: Screening Study at High-risk Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High-risk COPD
Keywords: high-risk COPD
scale
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: According to the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised in 2021), a multi-stage cluster random sampling method was used to select individuals from representative administrative villages with a history of chronic cough or sputum production, breathing difficulties, recurrent lower respiratory tract infections, and/or exposure to potential risk factors for chronic obstructive pulmonary disease.

Brief summary: This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD).

Detailed description: Targeting high-risk populations for chronic obstructive pulmonary disease (COPD), targeted at key issues such as unclear risk factors and lack of prevention and treatment plans, high-risk population screening was conducted to identify risk factors. This study is expected to detect at least 3600 high-risk individuals with early-stage chronic obstructive pulmonary disease. The incidence rate of high-risk individuals in the early stage of chronic obstructive pulmonary disease is 30%, which means the total screening population is 12000 cases.

Eligibility criteria: Inclusion Criteria:

* According to the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised in 2021), a multi-stage cluster random sampling method was used to select individuals from representative administrative villages with a history of chronic cough or sputum production, breathing difficulties, recurrent lower respiratory tract infections, and/or exposure to potential risk factors for chronic obstructive pulmonary disease.
* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion Criteria:

* Patients who are delirious, have impaired consciousness, dementia, various psychiatric disorders, etc., and cannot be accurately informed of their basic physical condition.
* Patients who, in the opinion of the investigator, are not suitable for participation in this study.

Primary outcomes:
measure: COPD screening questionnaire from Terrassa (EGARPOC)
timeFrame: During screening
measure: COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE)
timeFrame: During screening
measure: COPD Assessment Test (CAT)
timeFrame: During screening
measure: COPD screening questionnaire (COPD-Q)
timeFrame: During screening
measure: chronic obstructive pulmonary disease diagnostic questionnaire (CDQ)
timeFrame: During screening
measure: modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ)
timeFrame: During screening
measure: Simple screening questionnaire
timeFrame: During screening
measure: lung function questionnaire (LFQ)
timeFrame: During screening
measure: chronic obstructive pulmonary disease screening questionnaire (COPD-SQ)
timeFrame: During screening
measure: chronic obstructive pulmonary disease population screener questionnaire (COPD-PS)
timeFrame: During screening
measure: Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS)
timeFrame: During screening
measure: Standardised Scale of Physical Fitness in Chinese Medicine
timeFrame: During screening
measure: Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES)
timeFrame: During screening
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
Study officials:
References: