Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program
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|ClinicalTrials.gov Identifier: NCT00126776|
Recruitment Status : Completed
First Posted : August 4, 2005
Results First Posted : August 25, 2009
Last Update Posted : August 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Behavioral: case management Behavioral: usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||743 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||VISN 23 Lung Disease Self Management/Case Management Program|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||July 2008|
Active Comparator: 1
CAse/self management for COPD
Behavioral: case management
case/self management for COPD vs usual care
Behavioral: usual care
usual care for COPD
- Hospitalization or Emergency Department Visit for COPD [ Time Frame: 1 yr ]
- Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) [ Time Frame: 1 yr ]
- All Cause Hospitalizations [ Time Frame: 1 year ]
- Quality of Life [ Time Frame: 1 year ]
- COPD Exacerbations Requiring Antibiotics or Corticosteroids [ Time Frame: 1 year ]
- All Cause Mortality [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126776
|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, Minnesota, United States, 55417|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68105|
|United States, South Dakota|
|Sioux Falls VAMC|
|Sioux Falls, South Dakota, United States, 57117|
|Principal Investigator:||Kathryn L Rice, MD||Minneapolis Veterans Affairs Medical Center|
|Principal Investigator:||Naresh Dewan, MD||Omaha VA Medical Center|