Quality Control and Evaluation in Standard COPD Management | NCT03314077

Studies
Quality Control and Evaluation in Standard COPD Management

NCT03314077

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

210Actual

Phase

Not provided

Conditions

COPD

Interventions

GOLD 2017

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 15, 2017

First Submission Date that Met QC Criteria

Oct 15, 2017

First Posted Date

Oct 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weining Xiong, Professor, Tongji HospitalPrincipal Investigator

Lead Sponsor

Tongji HospitalOTHER

Collaborators

Name	Class
Guilin Medical University, China	OTHER
University hospital of Hubei university for nationalities,China	UNKNOWN
TongjiChibi hospital,China	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard managed subjects		COPD patients accepted standard COPD management.	Other: GOLD 2017
Controls		COPD patients didn't accepted standard COPD management or quality control, who are from hospital subjects with a retrospective cohort study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GOLD 2017	Other	Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.	Standard managed subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in spirometry	Spirometry will be assessed at baseline and through study completion	1 years

Secondary Outcomes

Measure	Description	Time Frame
Morbidity of acute exacerbation in 1 years	Morbidity of acute exacerbation completion will be assessed at baseline and through study	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70

Exclusion Criteria:

1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Clinic-based population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TongjiChibi hospital		Chibi	Hubei		China
Tongji hospital

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided