Back to resultsEffect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational brochures
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD
Eligibility Criteria
Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC <70%.
Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year
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Sites / Locations
- Minneapolis VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational intervention
Arm Description
Subjects in this group will receive educational brochures about management of COPD
Outcomes
Primary Outcome Measures
Combined frequency of admissions and ED visits for COPD over 1 year.
Secondary Outcome Measures
Patient knowledge of COPD will be compared.
Use of respiratory medications will be compared
Full Information
NCT ID
NCT00932711
First Posted
July 2, 2009
Last Updated
July 2, 2009
Sponsor
VA Midwest Health Care Network
1. Study Identification
Unique Protocol Identification Number
NCT00932711
Brief Title
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
Official Title
Limited Intervention in Low Risk(Tier 3) COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
VA Midwest Health Care Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.
Detailed Description
There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
Subjects in this group will receive educational brochures about management of COPD
Intervention Type
Behavioral
Intervention Name(s)
Educational brochures
Intervention Description
A locally developed educational brochure containing information about smoking cessation, influenza and pneumococcal vaccination, regular exercise, compliance with prescribed COPD therapy and recognition of symptoms, along with a goal setting questionnaire
Primary Outcome Measure Information:
Title
Combined frequency of admissions and ED visits for COPD over 1 year.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Patient knowledge of COPD will be compared.
Time Frame
1 year
Title
Use of respiratory medications will be compared
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC <70%.
Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Rice, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
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