- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406534
A Prospective, Observational Study of COPD Patients in U.S. Hospitals
May 4, 2015 updated by: EPI-Q
This is an observational study to evaluate the relationship between pulmonary function and the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary disease (COPD) related admissions.
Patients with COPD will be approached to participate in the study.
Pulmonary function will be measured on consented, eligible patients.
The pulmonary function measurement collected will be used for cohort assignment.
The prospective follow up period will monitor the cohorts for evidence of readmission and to assess HRQoL.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COPD patients admitted for a COPD exacerbation.
Description
Inclusion Criteria:
≥ 18 years of age Fluent in English Current hospital admission is for COPD Diagnosis of COPD for at least 1 year prior to enrollment
Exclusion Criteria:
Unwilling or unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Normal Pulmonary Function
|
|
|
Reduced Pulmonary Function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
COPD related readmissions
Time Frame: 6 months
|
6 months
|
|
Health related quality of life (HRQoL)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Valerie Caroselli, EPI-Q
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
March 30, 2015
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 4, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000 (Other Identifier: YCTG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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