Skip to content

Screening for High-risk Chronic Obstructive Pulmonary Disease

Screening Study at High-risk Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06350305
Enrollment
3600
Registered
2024-04-05
Start date
2024-05-01
Completion date
2027-10-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk COPD

Keywords

high-risk COPD, scale

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.

Interventions

OTHERquestionnaire survey

subjects fill out questionnaires

Sponsors

Henan University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
COPD screening questionnaire from Terrassa (EGARPOC)During screening3-29 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)During screening0-6 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)During screening0-40 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)During screening0-10 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)During screening0-38 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)During screening0-45 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 questionnaireDuring screening0-11 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)During screening5-25 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)During screening0-38 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)During screening0-10 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)During screening0-9 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 MedicineDuring screeningAnswer 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)During screeningSubjects 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.

Countries

China

Contacts

Primary Contactyang xie, doctor
xieyanghn@163.com0371-66248624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026