Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms
Brief 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.
Detailed description
COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China. The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 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.
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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Statisticians and outcome assessors will be blinded
Intervention model description
A parallel, cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥40 years 2. Post-bronchodilator FEV1/FVC \<70% 3. Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission. 4. Local residents who live nearby and can be followed up throughout study period 5. Written informed consent
Exclusion criteria
1. Pregnancy, breastfeeding, or potential pregnancy 2. Primary diagnosis of asthma 3. Having severe cognitive dysfunction 4. Severely ill with less than 12-month life expectancy 5. Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake \>80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years. 6. Have participated in similar trials or are undergoing other clinical trials 7. Refuses or unable to give informed consent 8. Plan to move 9. Contraindicated to maintenance medicine. 10. Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry. 11. Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months. 12. Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment 13. Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment. 14. Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 12 months from baseline | The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmissions | 12 months from baseline | Number of readmissions within 30 days after discharge, time to first readmission within 30 days after discharge in days, number of readmissions within 90 days after discharge, time to first readmission within 90 days after discharge in days |
| Hospital stay | 12 months from baseline | Average length of hospital stay in days |
| Healthcare cost | 12 months from baseline | Total COPD-related health care cost in rmb |
| Lung function change | 12 months from baseline | Change in FEV1 from baseline to 12 months in liter |
| Symptom change | 12 months from baseline | Units on SGRQ-C score change from baseline to 12 months, units on CAT score change from baseline to 12 months, units on mMRC score change from baseline to 12 months |
| Patients' care-seeking behaviors | 12 months from baseline | Number of patients' contacting physicians for medical advice, number of patients' hospital visits to seek care |
| Patients' adherence to treatment | 12 months from baseline | Time of patients' adherence to inhaler medication use in days |
| Exacerbation events | 12 months from baseline | Time to first moderate exacerbation in days, time to first severe exacerbation in days, time to first exacerbation-related hospitalization in days, time to first exacerbation-related emergency admissions in days, time elapsed from patient enrollment until first admission for acute exacerbation in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse event | 12 months from baseline | Number of patients with pneumonia caused by ICS-containing treatment, number of patients with tobacco cessation related adverse events, number of patients with pulmonary rehabilitation related adverse events, number of patients with flu vaccination related adverse events, number of patients with pneumonia vaccination related adverse events |
Countries
China
Contacts
Primary ContactTing Yang, MD, Ph.D
Outcome results
None listed