Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00932711
First received: July 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 2, 2009 | ||||
| Last Updated Date | July 2, 2009 | ||||
| Start Date ICMJE | July 2009 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Combined frequency of admissions and ED visits for COPD over 1 year. [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Limited Intervention in Low Risk(Tier 3) COPD Patients | ||||
| 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. |
||||
| Detailed Description | There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||
| Intervention ICMJE | Behavioral: Educational brochures
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 |
||||
| Study Arm (s) | Experimental: Educational intervention
Subjects in this group will receive educational brochures about management of COPD
Intervention: Behavioral: Educational brochures |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 4000 | ||||
| Estimated Completion Date | July 2011 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC <70%. Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year - |
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00932711 | ||||
| Other Study ID Numbers ICMJE | 4140-B | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kathryn Rice, MD, Minneapolis VA Medical Center | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Minneapolis Veterans Affairs Medical Center | ||||
| Verification Date | June 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||