NCT00126776

Brief Summary

The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

5 active sites

Status
completed

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, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2009

Completed
Last Updated

August 25, 2009

Status Verified

July 1, 2009

Enrollment Period

3.4 years

First QC Date

August 3, 2005

Results QC Date

July 14, 2009

Last Update Submit

July 14, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary diseasecase managementself management

Outcome Measures

Primary Outcomes (2)

  • Hospitalization or Emergency Department Visit for COPD

    1 yr

  • Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)

    1 yr

Secondary Outcomes (4)

  • All Cause Hospitalizations

    1 year

  • Quality of Life

    1 year

  • COPD Exacerbations Requiring Antibiotics or Corticosteroids

    1 year

  • All Cause Mortality

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

CAse/self management for COPD

Behavioral: case management

2

OTHER

usual care

Behavioral: usual care

Interventions

case managementBEHAVIORAL

case/self management for COPD vs usual care

1
usual careBEHAVIORAL

usual care for COPD

2

Eligibility Criteria

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

You may qualify if:

  • One or more of the following:
  • Hospital admission for COPD within the prior year
  • Unscheduled visit for COPD within the prior year
  • Home oxygen use for COPD
  • Systemic steroid use for COPD within the prior year
  • Post bronchodilator FEV1 \< 70% predicted
  • Post bronchodilator FEV1/FVC \< 70% predicted

You may not qualify if:

  • Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to \< 1 year
  • Inability to contact patient by telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Des Moines VA

Des Moines, Iowa, 50310, United States

Location

IA City VA

Iowa City, Iowa, 52246, United States

Location

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

Omaha VAMC

Omaha, Nebraska, 68105, United States

Location

Sioux Falls VAMC

Sioux Falls, South Dakota, 57117, United States

Location

Related Publications (1)

  • Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):890-6. doi: 10.1164/rccm.200910-1579OC. Epub 2010 Jan 14.

    PMID: 20075385DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Case Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Kathryn Rice MD
Organization
Minneapolis VAMC
kathryn.rice@va.gov
612 725 2000

Study Officials

  • Kathryn L Rice, MD

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Naresh Dewan, MD

    VA Nebraska Western Iowa Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 4, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

August 25, 2009

Results First Posted

August 25, 2009

Record last verified: 2009-07

Locations

US(5)