Screening for High-risk Chronic Obstructive Pulmonary Disease

NCT06350305 | Not Yet Recruiting DMC

• 1 other identifier: Screening for high-risk COPD
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

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).

Conditions

High-risk COPD

Keywords

high-risk COPD; scale

Outcome Measures

Primary Outcomes (13)

• 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

Interventions

questionnaire survey OTHER

subjects fill out questionnaires

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

yang xie, doctor

CONTACT

0371-66248624; xieyanghn@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)