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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00932711
First received: July 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Limited Intervention in Low Risk(Tier 3) COPD Patients

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient knowledge of COPD will be compared. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Use of respiratory medications will be compared [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932711

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

No publications provided

Responsible Party: Kathryn Rice, MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT00932711     History of Changes
Other Study ID Numbers: 4140-B
Study First Received: July 2, 2009
Last Updated: July 2, 2009
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
COPD

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

ClinicalTrials.gov processed this record on May 22, 2013