Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126776
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2005-08-03
Brief Title:
Veterans Integrated Service Network VISN 23 Lung Disease Self ManagementCase Management Program
Sponsor:
US Department of Veterans Affairs
Organization:
VA Midwest Health Care Network
Study Overview
Official Title:
VISN 23 Lung Disease Self ManagementCase Management Program
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 caseself 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 inclusionexclusion 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 caseself management intervention by means of sealed sequentially numbered envelopes at each site
Patients who are randomized to caseself 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 Georges 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
This is a one-year 5-site randomized trial High-risk patients will be randomized to usual care or a caseself 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 inclusionexclusion 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 caseself management intervention by means of sealed sequentially numbered envelopes at each site
Patients who are randomized to caseself 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 Georges 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None