Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
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|ClinicalTrials.gov Identifier: NCT00395083|
Recruitment Status : Terminated (The DMC detected an imbalance in safety outcomes between the two groups.)
First Posted : November 2, 2006
Results First Posted : August 21, 2014
Last Update Posted : September 15, 2014
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.
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.
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.
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.
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
- Health-related quality of life measured by generic and COPD-specific measures
- Patient satisfaction
- Medication adherence
- Disease knowledge, skill acquisition and self-efficacy
In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.
|Condition or disease||Intervention/treatment||Phase|
|COPD Emphysema||Behavioral: COPD Self-management Education||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
No Intervention: Group 1
Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
Experimental: Group 2
The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
Behavioral: COPD Self-management Education
The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
- Hospitalization-free Survival - Time to Event [ Time Frame: From randomization until date of first hospitalization for COPD, assessed up to 26 months ]
- Hazard Ratio for First COPD Hospitalization [ Time Frame: 26 months ]
- Hazard Ratio for All-Cause Mortality [ Time Frame: 26 months ]
- Time to All-Cause Death [ Time Frame: From randomization until death, assessed up to 26 months ]
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): NCT00395083
|Study Chair:||Vincent S. Fan, MD MPH||VA Puget Sound Health Care System|