The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000, China
Not Yet Recruiting
NCT Number: NCT06350305
Screening for High-risk Chronic Obstructive Pulmonary Disease
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).
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
questionnaire survey
Othersubjects fill out questionnaires
Primary outcomes
-
COPD screening questionnaire from Terrassa (EGARPOC)
Time frame: During screening
3-29 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥13, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE)
Time frame: During screening
0-6 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥2, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
COPD Assessment Test (CAT)
Time frame: During screening
0-40 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was >10, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
COPD screening questionnaire (COPD-Q)
Time frame: During screening
0-10 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥4, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
chronic obstructive pulmonary disease diagnostic questionnaire (CDQ)
Time frame: During screening
0-38 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥17, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ)
Time frame: During screening
0-45 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥18, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
Simple screening questionnaire
Time frame: During screening
0-11 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥6, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
lung function questionnaire (LFQ)
Time frame: During screening
5-25 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≤18, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
chronic obstructive pulmonary disease screening questionnaire (COPD-SQ)
Time frame: During screening
0-38 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥16, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
chronic obstructive pulmonary disease population screener questionnaire (COPD-PS)
Time frame: During screening
0-10 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥5, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS)
Time frame: During screening
0-9 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥5, the participant needed to be seen by a physician for further testing to determine if they had COPD.
-
Standardised Scale of Physical Fitness in Chinese Medicine
Time frame: During screening
Answer all the questions in the Classification and Determination of Physical Qualities in Chinese Medicine Table. Each question is rated on a 5-point scale, and the raw and transformed scores are calculated to determine the type of physical qualities according to the criteria. Raw score = sum of the scores of each entry. Transformation score = [(raw score - number of entries)/(number of entries × 4)] × 100.
-
Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES)
Time frame: During screening
Subjects should fill in the relevant entries truthfully according to the category of symptoms as judged by the doctor and tick the appropriate box. Among them, the part of tongue and pulse should be filled in by the doctor.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Henan University of Traditional Chinese Medicine
Other
Registry information
Official study title
Screening Study at High-risk Chronic Obstructive Pulmonary Disease
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 5, 2024
- Registry last updated
- Apr 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.