Study protocol for evaluating the efficacy of early pulmonary rehabilitation combined with an internet-based patient management model in patients with COPD: a practical, multicentre, randomised controlled study from China

Abstract

Background COPD, a preventable and treatable disease, is characterised by persistent respiratory symptoms and airflow limitations, with high incidence, disability, mortality and disease burden. Currently, drug treatments mainly include bronchodilators and glucocorticoids, which are used to alleviate symptoms and improve lung function. Traditional medical care models and patients' lack of understanding of the disease result in regular and long-term hospitalisations, affect patients’ quality of life and cause a need to explore more effective comprehensive intervention plans. Methods This study is designed as a multicentre, randomised controlled trial consisting of three parallel groups. Group A will receive early pulmonary rehabilitation in the hospital and remote internet pulmonary rehabilitation after discharge. Group B will receive the same early pulmonary rehabilitation in the hospital but outpatient pulmonary rehabilitation after discharge for 8 weeks and routine follow-up management. Group C will receive outpatient pulmonary rehabilitation during a stable period of 3–4 weeks after discharge and routine follow-up management. 1482 patients will be enrolled from 10 centres in China. The primary outcome measures will be the readmission rate due to acute exacerbation at 90 days and the 12-month readmission rate due to acute exacerbation. The secondary outcomes will mainly include differences in all-cause mortality; the number of acute exacerbations; COPD Assessment Test, modified Medical Research Council scale and St George's Respiratory Questionnaire scores; the pulmonary rehabilitation treatment completion rate; patient compliance; and patient and physician satisfaction scores among the three groups at 3, 6 and 12 months after the different interventions. In addition, the proportion of people with ≥2 acute exacerbations within 12 months and the time of the first acute exacerbation will also be included. Conclusions This study aims to further verify the substitutability of remote internet pulmonary rehabilitation for outpatient rehabilitation and its short-term and long-term effects in patients, providing comprehensive interventional evidence for the treatment of COPD.