NCT00932711

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 3, 2009

Status Verified

June 1, 2009

Enrollment Period

11 months

First QC Date

July 2, 2009

Last Update Submit

July 2, 2009

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Combined frequency of admissions and ED visits for COPD over 1 year.

    One year

Secondary Outcomes (2)

  • Patient knowledge of COPD will be compared.

    1 year

  • Use of respiratory medications will be compared

    1 year

Study Arms (1)

Educational intervention

EXPERIMENTAL

Subjects in this group will receive educational brochures about management of COPD

Behavioral: Educational brochures

Interventions

Educational brochuresBEHAVIORAL

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

Educational intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathryn Rice, MD

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2011

Last Updated

July 3, 2009

Record last verified: 2009-06

Locations

US(1)