NCT03314077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

October 15, 2017

Last Update Submit

March 24, 2020

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Change in spirometry

    Spirometry will be assessed at baseline and through study completion

    1 years

Secondary Outcomes (1)

  • Morbidity of acute exacerbation in 1 years

    1 year

Study Arms (2)

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

GOLD 2017OTHER

Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.

Standard managed subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinic-based population

You may qualify if:

  • Clinical manifestation of COPD; post bronchodilator FEV1/FVC\<0.70

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TongjiChibi hospital

Chibi, Hubei, China

Location

Tongji hospital

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 19, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CN(2)