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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: Clinical Trial Phase 2 study, sponsored by US Department of Veterans Affairs.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00395083 stopped before completion
NCT00395083 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher).
The record links to 0 conditions, and to 1 intervention - of which COPD Self-management Education is the first listed.
NCT00395083 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00395083's enrollment target sits among peer trials
426 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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