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COPD screening and the effect of an Structured Educational Programon on outcomes of COPD in Primary Care

COPD screening and the effect of an Structured Educational Programon Outcomes of COPD in Primary Care: A 1-year, multicentre, randomized, open-label, active-controlled, paralled-group study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003442
Enrollment
Unknown
Registered
2013-04-02
Start date
2013-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic obstructive pulmonary disease

Interventions

experimental group:COPD educational booklet face-to-face counselling sessions of experts to patients
Control Group:usual care

Sponsors

State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases,First Affiliated Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Chinese male or female outpatients aged 40 to 85 years; 2. Patients with an new established diagnosis of COPD, defined as 2011 GOLD guideline: Postbronchodilation FEV1/FVC ratio of <70%; 3. patients in stable stages,defined as having no respiratory infections within 4 weeks; 4. Patients who must be able to converse in and read. Patients who must also understand the study and give informed consent; 5. Patients willing and able to complete relevant examinations.

Exclusion criteria

Exclusion criteria: 1. history of an lung function diagnosed COPD or emphysema or cor pulmonale; 2. in addition to COPD, having an other major diseases, defined as: diseases or condition that would make the patients at risk when participating in the reseach, or would affect the reseach results, or would limit patients ability with fininshing the reseach according to the researcher's judgment; 3. clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or other simple restrictive ventilatory dysfunction; 4. serious heart, brain, liver, kidney and blood system diseases or malignant tumor, etc. 5. history of asthma and/or allergic rhinitis; 6. active tuberculosis; 7. a life-threatening pulmonary embolism, or alpha 1 - antitrypsin deficiency, or cystic fibrosis; 8. history of pneumonectomy; 9. COPD exacerbations within 4 weeks before the first visit (V0), or need to be hospitalized and/or antibiotic treatment and/or oral or intravenous hormone therapy during recruiting time (could be delay); 10. cognitive impairment and mental disorder; 11. musculoskeletal or nervous system disorders as cannot undertake everyday activities; 12. history of retinal detachment; 13. history of chronic alcoholism, drug abuse, or any other factors that affect adherence; 14. currently engaged in other clinical trials.

Design outcomes

Primary

MeasureTime frame
number and severity of COPD exacerbation;

Secondary

MeasureTime frame
last days and treatment of COPD exacerbation;self-management efficacy;medication accuracy and compliance;post-broncholidator FEV1?FVC?FEV1/FVC;distance of 6MWT;MMRC;CAT;CCQ;PE;

Countries

China

Contacts

Public ContactRan Peixin
pxran@vip.163.com+86 13922765811

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026