Screening for High-risk Chronic Obstructive Pulmonary Disease

Screening Study at 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).

Study Overview

• Status: Not yet recruiting
• Conditions: High-risk COPD
• Intervention / Treatment: Other: questionnaire survey

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.

• Study Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

• Study Contact: Name: yang Xie, doctor; Phone Number: 0371-66248624; Email: xieyanghn@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: yang Xie, doctor; Phone Number: 0371-66248624; Email: xieyanghn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD screening questionnaire from Terrassa (EGARPOC)	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.	During screening
COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE)	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.	During screening
COPD Assessment Test (CAT)	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.	During screening
COPD screening questionnaire (COPD-Q)	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.	During screening
chronic obstructive pulmonary disease diagnostic questionnaire (CDQ)	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.	During screening
modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ)	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.	During screening
Simple screening questionnaire	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.	During screening
lung function questionnaire (LFQ)	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.	During screening
chronic obstructive pulmonary disease screening questionnaire (COPD-SQ)	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.	During screening
chronic obstructive pulmonary disease population screener questionnaire (COPD-PS)	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.	During screening
Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS)	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.	During screening
Standardised Scale of Physical Fitness in Chinese Medicine	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.	During screening
Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES)	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.	During screening

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: scale; high-risk COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Screening for high-risk COPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No