Clinical trial NCT04318912: An Observational Registry of Chinese COPD Study
Official title: An Observational Registry Study for Management of COPD Patients in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Keywords: COPD
health policy
telimedicine
management
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Have plans for future visits at the site for continued management of COPD.

Exclusion Criteria:

1. Inability to provide written informed consent/assent.
2. Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).

Primary outcomes:
measure: Characterize COPD Disease Severity in Clinical Practice
timeFrame: 2 years
measure: Characterize COPD Disease Activity in Clinical Practice
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate Medical Expenditure in Clinical Practice
timeFrame: 2 years
measure: Evaluate Patient Reported Outcome
timeFrame: 2 years
measure: Evaluate Health Related Quality of Life
timeFrame: 2 years
measure: Evaluate Digital Health Technology Outcome
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Chen Wang
role: STUDY_DIRECTOR
References:
citation: Jia C, Zhang C, Fang F, Huang K, Dong F, Gu X, Niu H, Li S, Wang C, Yang T. Enjoying Breathing Program: A National Prospective Study Protocol to Improve Chronic Obstructive Pulmonary Disease Management in Chinese Primary Health Care. Int J Chron Obstruct Pulmon Dis. 2020 Sep 15;15:2179-2187. doi: 10.2147/COPD.S258479. eCollection 2020.