Effects of COPD Standardized Management on COPD Exacerbation

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

COPD is the most common chronic respiratory disease in China and has caused significant economic and disease burden. An effective and standardized condition management strategy is urgently needed to reduce the incidence of acute exacerbation, improve the quality of patients' life, and avoid premature death caused by COPD. At present, management of COPD is mainly conducted in community-level health institutions. Implementing standardized management of COPD in primary care will help improve the level of COPD prevention and treatment in China.

We will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial, involving 96 secondary hospitals across the country. Each hospital enrolls 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care. ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT04664491
• Study type: Interventional
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD, Ph.D
• Phone: 13651380809
• Email: dryangting@qq.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Completion date: December 31, 2022