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An Observational Registry of Chinese COPD Study (ORCHIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318912
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hongtao Niu, China-Japan Friendship Hospital

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: An Observational Registry Study for Management of COPD Patients in China
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2030

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.



Primary Outcome Measures :
  1. Characterize COPD Disease Severity in Clinical Practice [ Time Frame: 2 years ]
    Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD

  2. Characterize COPD Disease Activity in Clinical Practice [ Time Frame: 2 years ]
    Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.


Secondary Outcome Measures :
  1. Evaluate Medical Expenditure in Clinical Practice [ Time Frame: 2 years ]
    Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.

  2. Evaluate Patient Reported Outcome [ Time Frame: 2 years ]
    COPD Assessment Test (CAT) is an 8-item, self-reported scale which can represent symptom and health status for COPD patients.

  3. Evaluate Health Related Quality of Life [ Time Frame: 2 years ]
    Euroqol-5 Dimension Questionnaire (EQ-5D) is an 5-item, self-reported scale which can measure health related quality of life.

  4. Evaluate Digital Health Technology Outcome [ Time Frame: 2 years ]
    Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318912


Contacts
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Contact: Ting Yang +861084206276 dryangting@qq.com
Contact: Shiyi Gong +8618813185680 gongshiyi1995@pku.edu.cn

Sponsors and Collaborators
China-Japan Friendship Hospital
Investigators
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Study Director: Chen Wang China-Japan Friendship Hospital
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Responsible Party: Hongtao Niu, Resident Doctor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT04318912    
Other Study ID Numbers: 21971
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongtao Niu, China-Japan Friendship Hospital:
COPD
health policy
telimedicine
management