Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126776
First received: August 3, 2005
Last updated: July 14, 2009
Last verified: July 2009
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: case management
Behavioral: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VISN 23 Lung Disease Self Management/Case Management Program

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Hospitalization or Emergency Department Visit for COPD [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Cause Hospitalizations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • COPD Exacerbations Requiring Antibiotics or Corticosteroids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 743
Study Start Date: July 2004
Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
CAse/self management for COPD
Behavioral: case management
case/self management for COPD vs usual care
2
usual care
Behavioral: usual care
usual care for COPD

Detailed Description:

Study design and plan:

This is a one-year, 5-site randomized trial. High-risk patients will be randomized to usual care or a case/self management intervention. The frequency of urgent care visits or admission to a hospital for COPD will be compared.

Study procedures: visit 1 Patient informed consent will be obtained prior to patient participation in the trial.

Patients will also sign a release of information form to obtain outside records of COPD admissions or urgent care visits.

Demographic data, inclusion/exclusion data, medications and problem list will be obtained.

Post-albuterol forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be performed using calibrated spirometers in accordance with guidelines established by the American Thoracic Society. A uniform set of nomograms (NHANES III) will be used at all sites. The best of three efforts will be defined as the highest FEV1 and the highest FVC obtained on any of the three blows (even if not from the same curve with a maximum of 5 attempts).

Patients who meet all above criteria and who agree to participation will be randomized to usual care or the case/self management intervention, by means of sealed sequentially numbered envelopes at each site.

Patients who are randomized to case/self management intervention will receive 1-2 hours of education (appendix 1). These patients will be given instructions for self-management of exacerbation and a telephone care contact number. Coordinators will confirm that the patient has been instructed about, and is in possession of, standard pharmacologic treatment of exacerbation, including a 10 day supply of oral prednisone and an oral antibiotic. Prednisone dose regimens and specific antibiotics will be determined by the site PI according to local sensitivities and practice patterns, with access to current disease management recommendations and information.

Study procedures: treatment period All patients will be contacted by telephone every 6 weeks by a blinded centralized study staff member who will inquire about interim urgent care visits and hospitalizations and COPD exacerbations according to a scripted case report form.

Patients in the intervention arm will be contacted by the site coordinator monthly to reinforce educational principles and assist patients with disease management questions or concerns.

Study procedures: end of trial At the end of one year quality of life scores (SF36 and St. George's Respiratory Questionnaire, a VISN 23 patient satisfaction survey, and a brief questionnaire regarding current influenza and pneumococcal vaccination status, smoking status, and average number of minutes of exercise per day will be mailed to all patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126776

Locations
United States, Iowa
Des Moines VA
Des Moines, Iowa, United States, 50310
IA City VA
Iowa City, Iowa, United States, 52246
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
Omaha VAMC
Omaha, Nebraska, United States, 68105
United States, South Dakota
Sioux Falls VAMC
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Investigators
Principal Investigator: Kathryn L Rice, MD Minneapolis Veterans Affairs Medical Center
Principal Investigator: Naresh Dewan, MD Omaha VA Medical Center
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathryn Rice MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT00126776     History of Changes
Other Study ID Numbers: VISN 23 PC-SI 0401
Study First Received: August 3, 2005
Results First Received: July 14, 2009
Last Updated: July 14, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic obstructive pulmonary disease
case management
self management

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

ClinicalTrials.gov processed this record on April 17, 2014