Study Stopped
The DMC detected an imbalance in safety outcomes between the two groups.
Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
BREATH
CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
1 other identifier
interventional
426
1 country
22
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2006
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedSeptember 15, 2014
September 1, 2014
4.2 years
November 1, 2006
August 4, 2014
September 4, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Hospitalization-free Survival - Time to Event
From randomization until date of first hospitalization for COPD, assessed up to 26 months
Hazard Ratio for First COPD Hospitalization
26 months
Secondary Outcomes (2)
Hazard Ratio for All-Cause Mortality
26 months
Time to All-Cause Death
From randomization until death, assessed up to 26 months
Study Arms (2)
Group 1
NO INTERVENTIONPatients 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.
Group 2
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Population to be studied
- The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.
- Diagnosis of COPD confirmed by all of the following:
- FEV1/FVC \< 0.70
- FEV1 \< 80%
- Age \> 40 years
- A current or past history of cigarette smoking (\> 10 pack-years)
- COPD hospitalization in the previous year
- Receives care at participating VA medical center
- Enrolled in either primary care or pulmonary clinic at the VA
- Seen at least once in the past year in either primary care or pulmonary clinic
- No COPD exacerbations in last 4 weeks
- English-speaking
- Access to telephone
You may not qualify if:
- Primary clinical diagnosis of asthma
- Medical conditions affecting the ability to participate in the study such as:
- Comorbid illness likely to limit life expectancy \< 1 year
- Decompensated heart failure
- Dementia
- Uncontrolled psychiatric illness
- Participation in another clinical intervention trial in the previous 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
VA Medical Center, Loma Linda
Loma Linda, California, 92357, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
Robert J. Dole VAMC & ROC, Wichita
Wichita, Kansas, 67218, United States
VA Medical Center, Lexington
Lexington, Kentucky, 40502, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215, United States
New York Harbor HCS
New York, New York, 10010, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
VA Medical Center, Providence
Providence, Rhode Island, 02908, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
VA Puget Sound Health Care System
Seattle, Washington, 98101, United States
Related Publications (1)
Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.
PMID: 22586006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sarah Leatherman
- Organization
- VA Boston Healthcare System - MAVERIC
Study Officials
- STUDY CHAIR
Vincent S. Fan, MD MPH
VA Puget Sound Health Care System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 2, 2006
Study Start
July 1, 2006
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
September 15, 2014
Results First Posted
August 21, 2014
Record last verified: 2014-09