An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, Patient Education, Inpatients
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inpatient COPD education
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- History of COPD
- Spirometry confirmation of COPD either from chart or bedside spirometry i. FEV1(forced expiatory volume in 1 second)/FVC (forced vital capacity) <70% ii. FEV1 < 80% predicted
- Willingness to participate
- English-speaking
- Working phone
Exclusion Criteria:
- Cognitively impaired (including sedation)
- Intubated
- Non-English-speaking
- Receiving palliative or hospice service
- Enrolled in any other educational research s
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inpatient COPD patient
Arm Description
All COPD patients meeting the inclusion criteria of this study will be exposed to inpatient COPD education and tested at a later date to determine if knowledge on COPD was gained.
Outcomes
Primary Outcome Measures
Gained knowledge
Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
Secondary Outcome Measures
Pulmonary rehab enrollment
Number of subjects that have enrolled in pulmonary rehab.
Full Information
NCT ID
NCT03323190
First Posted
February 10, 2017
Last Updated
December 8, 2020
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03323190
Brief Title
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
Official Title
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to low feasibility.
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.
Detailed Description
A prospective cohort study utilizing a pre-test/post-test design will be used to test a COPD education intervention on a convenience sample of 30 patients with a diagnosis of COPD. Study participants will complete the Chronic Obstructive Pulmonary Disease questionnaire (COPD-Q) to assess their COPD knowledge. Next, a respiratory therapist will provide the first scripted COPD education session. The patient will complete the COPD-Q 24 hours and 30 days post-discharge. Demographic data, smoking status, pack-years, COPD spirometry grade, COPD symptom and exacerbation grade, previous hospital admissions, support system for managing COPD, attendance at previous formal education for COPD, current and home medications, pulmonary function test (PFT) results, vaccinations, and level of education data will be collected. Data related to patient recruitment will also be collected. Means and standard deviation will be reported for interval data. Total frequency and percentages will be reported for nominal data, and median and 25th and 75th percentile will be reported for COPD severity. Repeated measures ANOVA (p< 0.05) will be used to evaluate if an inpatient COPD self-management intervention can increase the patient's knowledge of COPD after 24 hours and again at 30 days after the initial education session.
This study is expected to show that an inpatient education of COPD can increase the patient's COPD knowledge prior to discharge and that it will be retained for at least one month post-discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Patient Education, Inpatients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inpatient COPD patient
Arm Type
Experimental
Arm Description
All COPD patients meeting the inclusion criteria of this study will be exposed to inpatient COPD education and tested at a later date to determine if knowledge on COPD was gained.
Intervention Type
Behavioral
Intervention Name(s)
Inpatient COPD education
Primary Outcome Measure Information:
Title
Gained knowledge
Description
Change from baseline on the Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pulmonary rehab enrollment
Description
Number of subjects that have enrolled in pulmonary rehab.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of COPD
Spirometry confirmation of COPD either from chart or bedside spirometry i. FEV1(forced expiatory volume in 1 second)/FVC (forced vital capacity) <70% ii. FEV1 < 80% predicted
Willingness to participate
English-speaking
Working phone
Exclusion Criteria:
Cognitively impaired (including sedation)
Intubated
Non-English-speaking
Receiving palliative or hospice service
Enrolled in any other educational research s
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD
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