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REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol.

ABSTRACT: BACKGROUND:Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death in China with a reported prevalence of 8.2% people aged ?40?years. It is recommended that Chinese physicians follow Global Initiative for Chronic Obstructive Lung Disease (GOLD) and national guidelines, yet many patients with COPD in China remain undiagnosed. Furthermore, missed diagnoses and a lack of standardized diagnosis and treatment remain significant problems. The situation is further complicated by a lack of large-scale, long-term, prospective studies of real-world outcomes, including exacerbation rates, disease severity, efficacy of treatment, and compliance of COPD patients in China. METHODS/DESIGN:The REALizing and improving management of stable COPD in China (REAL) study is a 52-week multi-center, prospective, observational trial. REAL aims to recruit approximately 5000 outpatients aged ?40?years with a clinical diagnosis of COPD per GOLD 2016. Outpatients will be consecutively recruited from approximately 50 tertiary and secondary hospitals randomly selected across six geographic regions to provide a representative population. Patients will receive conventional medical care as determined by their treating physicians. The primary objective is to evaluate COPD patient outcomes including lung function, health status, exacerbations, hospitalization rate, and dyspnea following 1 year of current clinical practice. Secondary objectives are to assess disease severity, treatment patterns, adherence to medication, and associated risk factors. Data will be collected at two study visits, at patients' usual care visits, and by telephone interview every 3?months. DISCUSSION:Knowledge of COPD among physicians in China is poor. The REAL study will provide reliable information on COPD management, outcomes, and risk factors that may help improve the standard of care in China. Patient recruitment began on 30 June 2017 and the estimated primary completion date is 30 July 2019. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03131362. Registered on 20 March 2017.

SUBMITTER: Yang T

PROVIDER: S-EPMC6958695 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol.

Yang Ting T Cai Baiqiang B Cao Bin B Kang Jian J Wen Fuqiang F Yao Wanzhen W Zheng Jinping J Ling Xia X Shang Hongyan H Wang Chen C

BMC pulmonary medicine 20200113 1

<h4>Background</h4>Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death in China with a reported prevalence of 8.2% people aged ≥40 years. It is recommended that Chinese physicians follow Global Initiative for Chronic Obstructive Lung Disease (GOLD) and national guidelines, yet many patients with COPD in China remain undiagnosed. Furthermore, missed diagnoses and a lack of standardized diagnosis and treatment remain significant problems. The situation is further compl ...[more]

PMID: 31931767

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Project description:BackgroundChronic obstructive pulmonary disease (COPD) management in China is far from adequate; underdiagnosis and undertreatment are major barriers to optimal care and improved patient outcomes.ObjectiveTo generate reliable information on COPD management, outcomes, treatment patterns and adherence, and disease knowledge in China in a real-world setting.DesignA 52-week multicentre, prospective, observational study.MethodsOutpatients (⩾40 years old) diagnosed with COPD were enrolled from 50 secondary and tertiary hospitals across six geographical regions. Data were collected in routine clinical practice.ResultsBetween June 2017 and January 2019, 5013 patients were enrolled and 4978 included in the analysis. Mean [standard deviation (SD)] age was 66.2 (8.9) years, 79.5% were male and 90% had moderate-to-very-severe airflow limitation. Annual rates of overall and severe exacerbation were 0.56 and 0.31, respectively. During 1 year, 1536 (30.8%) patients experienced ⩾1 exacerbation and 960 (19.3%) patients had ⩾1 exacerbation requiring hospitalization/emergency visit. Mean (SD) COPD assessment test score was 14.6 (7.6) at baseline and 10.6 (6.8) at follow-up; however, 42-55% of patients had persistent dyspnoea, chest tightness and wheezing at 1 year. The most prescribed treatments were inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) (36.0%), ICS/LABA + long-acting muscarinic antagonist (LAMA) (17.7%) and LAMA monotherapy (15.3%). Among patients with high exacerbation risk (GOLD Groups C and D), 10.1% and 13.1%, respectively, did not receive any long-acting inhalers; only 53.8% and 63.6% of Group C and D patients with ⩾1 exacerbation during follow-up were prescribed ICS-containing therapy, respectively. Mean (SD) adherence for long-acting inhalers was 59.0% (34.3%). Mean (SD) score for the COPD questionnaire was 6.7 (2.4).ConclusionThese results indicate a high burden of severe exacerbations and symptoms in Chinese outpatients with COPD, and low adherence with treatment guidelines, highlighting the need for more effective management nationwide.RegistrationThe trial was registered on 20 March 2017 (ClinicalTrials.gov identifier: NCT03131362).

Project description:Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.

Dataset Information

REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol.

Publications

REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol.

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