NCT02406534

Brief Summary

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

First QC Date

March 30, 2015

Last Update Submit

May 4, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • COPD related readmissions

    6 months

  • Health related quality of life (HRQoL)

    6 months

Study Arms (2)

Normal Pulmonary Function

Behavioral: HRQoL surveys

Reduced Pulmonary Function

Behavioral: HRQoL surveys

Interventions

HRQoL surveysBEHAVIORAL
Normal Pulmonary FunctionReduced Pulmonary Function

Eligibility Criteria

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

COPD patients admitted for a COPD exacerbation.

You may qualify if:

  • ≥ 18 years of age Fluent in English Current hospital admission is for COPD Diagnosis of COPD for at least 1 year prior to enrollment

You may not qualify if:

  • Unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Valerie Caroselli

    EPI-Q

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Primary Completion

April 1, 2016

Last Updated

May 6, 2015

Record last verified: 2015-05