An interventional study of Standardized COPD management and Routine COPD management in Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Prevention
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 3,456 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.
Behavioral: Standardized COPD management
Patients will undergo usual care according to current clinical practice in study sites.
Other: Routine 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.
Also known as: COPD management according to GOLD and China's guidelines for COPD care
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.
Annual rate of moderate and severe COPD exacerbations
Annual rate is an estimated mean number of exacerbations per patient per year
Time frame: 12 months from baseline
Effective assessments for secondary outcomes
Exacerbation numbers and the first exacerbation, hospitalisation, cost-effectiveness, lung function and respiratory symptoms, improvement of self-management.
Time frame: 12 months from baseline
Safety evaluation
Mortality and safety outcomes: deaths, death causes and adverse events,
Time frame: 12 months from baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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China-Japan Friendship Hospital