RecruitingNot ApplicableNCT04664491

Effects of COPD Standardized Management on COPD Exacerbation

Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial


Sponsor

China-Japan Friendship Hospital

Enrollment

3,456 participants

Start Date

Feb 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a structured COPD management program reduces flare-ups (exacerbations) in people with COPD compared to usual care. You may be eligible if... - You are 40 years or older - You have been diagnosed with COPD (confirmed by breathing tests showing FEV1/FVC below 70%) - You have had at least one flare-up in the past year or your symptom score is 10 or higher - You live nearby and can be followed throughout the study You may NOT be eligible if... - You are pregnant, breastfeeding, or may become pregnant - Your primary diagnosis is asthma - You have severe cognitive problems or a life expectancy under 12 months - You have unstable heart conditions that prevent breathing tests - You abuse alcohol heavily - You are enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStandardized COPD management

In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below. 1. Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy. 2. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ. 3. Regular pulmonary function testing for lung function monitoring 4. Strengthened COPD education 5. Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.

OTHERRoutine COPD management

Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT04664491


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