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:


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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014