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Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932711
First Posted: July 3, 2009
Last Update Posted: July 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Minneapolis Veterans Affairs Medical Center
  Purpose
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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive Behavioral: Educational brochures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Limited Intervention in Low Risk(Tier 3) COPD Patients

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Combined frequency of admissions and ED visits for COPD over 1 year. [ Time Frame: One year ]

Secondary Outcome Measures:
  • Patient knowledge of COPD will be compared. [ Time Frame: 1 year ]
  • Use of respiratory medications will be compared [ Time Frame: 1 year ]

Estimated Enrollment: 4000
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational intervention
Subjects in this group will receive educational brochures about management of COPD
Behavioral: Educational brochures
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932711


Locations
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kathryn Rice, MD Minneapolis Veterans Affairs Medical Center
  More Information

Responsible Party: Kathryn Rice, MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT00932711     History of Changes
Other Study ID Numbers: 4140-B
First Submitted: July 2, 2009
First Posted: July 3, 2009
Last Update Posted: July 3, 2009
Last Verified: June 2009

Keywords provided by Minneapolis Veterans Affairs Medical Center:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes