An observational study in COPD, sponsored by China-Japan Friendship Hospital. Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by China-Japan Friendship Hospital · Observational
This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.
COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.
China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults age 40 or older with COPD having been prescribed any COPD treatment outside of a clinical trial. 3000-5000 patients are planned to be recruited.
Exclusion Criteria:
Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.
Characterize COPD Disease Severity in Clinical Practice
Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD
Time frame: 2 years
Characterize COPD Disease Activity in Clinical Practice
Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.
Time frame: 2 years
Evaluate Medical Expenditure in Clinical Practice
Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.
Time frame: 2 years
Evaluate Patient Reported Outcome
COPD Assessment Test (CAT) is an 8-item, self-reported scale which can represent symptom and health status for COPD patients.
Time frame: 2 years
Evaluate Health Related Quality of Life
Euroqol-5 Dimension Questionnaire (EQ-5D) is an 5-item, self-reported scale which can measure health related quality of life.
Time frame: 2 years
Evaluate Digital Health Technology Outcome
Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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China-Japan Friendship Hospital