An Observational Registry of Chinese COPD Study (ORCHIDS)

An Observational Registry Study for Management of COPD Patients in China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Ting Yang; Phone Number: +861084206276; Email: dryangting@qq.com
• Study Contact Backup: Name: Shiyi Gong; Phone Number: +8618813185680; Email: gongshiyi1995@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COPD patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize COPD Disease Severity in Clinical Practice	Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD	2 years
Characterize COPD Disease Activity in Clinical Practice	Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Medical Expenditure in Clinical Practice	Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.	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.	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.	2 years
Evaluate Digital Health Technology Outcome	Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.	2 years

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Director: Chen Wang, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2030

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: COPD; management; health policy; telimedicine
• Other Study ID Numbers: 21971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No