Economic and Humanistic Impact of Low Peak Inspiratory Flow Rate (PIFR) In COPD Patients: An Observational Analysis



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:March 2015
End Date:April 2016
Contact:Valerie Caroselli, PharmD
Email:Valerie.Caroselli@epi-q.com
Phone:630-570-5505

Use our guide to learn which trials are right for you!

This is an observational study to study the relationship between PIFR (Peak Inspiratory Flow
Rate) and the patient reported HRQoL (Health Related Quality of Life) and COPD (Chronic
Obstructive Pulmonary Disease) related readmissions among COPD patients. Patients with COPD
will be approached prior to discharge to participate in the study. PIFR will be measured on
consented, eligible patients. The PIFR measurement collected at discharge will be used to
estimate the prevalence of Low PIFR and to ensure equitable enrollment into two equal
cohorts for follow up data collection. Patients enrolled in the two cohorts will be asked to
complete brief HRQoL surveys and basic demographic, clinical (e.g., medications,
comorbidities), and hospitalization data will be obtained through chart collection or
patient interview. The prospective follow up period will monitor the two cohorts for
evidence of readmission and to assess HRQoL.

This is an observational study to study the relationship between PIFR and the patient
reported HRQoL and COPD related readmissions among COPD patients.

Patients with COPD will be approached prior to discharge to participate in the study.
Consented, eligible patients will be asked to provide an inspiratory effort using the
In-Check™ DIAL Inspiratory Flow Meter to measure PIFR. The PIFR measurement collected at
discharge will be used to estimate the prevalence of Low PIFR and to ensure equitable
enrollment into two equal cohorts for follow up data collection.

Patients enrolled in the two cohorts will be asked to complete brief HRQoL surveys and basic
demographic, clinical (e.g., medications, comorbidities), and hospitalization data will be
obtained through chart collection or patient interview.

The prospective follow up period will monitor the two cohorts for evidence of readmission
and to assess HRQoL. The follow up period will require site personnel to collect data from
the patients' medical records during the six month post-discharge period, including the
frequency/dates of readmission(s), the duration of the hospitalization(s), the primary and
secondary reason(s) for the readmission, and medication use. At 30-, 90- and 180-days
post-discharge, patients will be contacted by site personnel to complete the HRQoL surveys
and to answer questions about medication use and readmissions.

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
We found this trial at
1
site
Oak Brook, Illinois 60523
?
mi
from
Oak Brook, IL
Click here to add this to my saved trials