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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Limited Intervention in Low Risk(Tier 3) COPD Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00932711
• Other study ID #: 4140-B
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 2, 2009
• Last updated: July 2, 2009
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2009
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: July 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined frequency of admissions and ED visits for COPD over 1 year.		One year	No
Secondary	Patient knowledge of COPD will be compared.		1 year	No
Secondary	Use of respiratory medications will be compared		1 year	No