Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00395083 · ClinicalTrials.gov registry record · Phase 2
Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 2
- Development phase
- 426
- Enrollment target
NCT00395083 is a Phase 2 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 426 participants.
The verdict
NCT00395083, a Phase 2 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 426 participants
- Enrollment target
Study Summary
EXECUTIVE SUMMARY: Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD. Hypotheses: Primary Hypothesis: Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care. Primary Objective: In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care. Secondary Hypotheses: Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy. Secondary Objectives: To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by: A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures 1. Mortality 2. Health-related quality of life measured by generic and COPD-specific measures 3. Patient satisfaction 4. Medication adherence 5. Disease knowledge, skill acquisition and self-efficacy In the proposed study, 960 veterans with severe COPD hospitalized in the
Interventions
- BEHAVIORAL COPD Self-management Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2006-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00395083
The ClinicalTrials.gov registry entry for NCT00395083 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 426 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which COPD Self-management Education is the first listed.
NCT00395083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00395083 about?
NCT00395083 is a clinical study titled "Bronchitis and Emphysema Advice and Training to Reduce Hospitalization". EXECUTIVE SUMMARY: Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe CO...
What is the current status of trial NCT00395083?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 426 participants. The study started on 2006-07. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00395083?
The interventions under investigation include: COPD Self-management Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT00395083?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.