Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)

This study has been terminated.
(The DMC detected an imbalance in safety outcomes between the two groups.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00395083
First received: November 1, 2006
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 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 Intervention Phase
COPD
Emphysema
Behavioral: COPD Self-management Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Time to First COPD Hospitalization After Randomization [ Time Frame: Randomization to Study End ] [ Designated as safety issue: No ]
  • Hazard Ratio for First COPD Hospitalization [ Time Frame: Randomization to Study End ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hazard Ratio for All-Cause Mortality [ Time Frame: Randomization to Study End ] [ Designated as safety issue: Yes ]
  • Time to All-Cause Death [ Time Frame: Randomization to Study End ] [ Designated as safety issue: Yes ]

Enrollment: 426
Study Start Date: July 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Inclusion Criteria:

  1. Diagnosis of COPD confirmed by all of the following:

    1. FEV1/FVC < 0.70
    2. FEV1 < 80%
    3. Age > 40 years
    4. A current or past history of cigarette smoking (> 10 pack-years)
  2. COPD hospitalization in the previous year
  3. Receives care at participating VA medical center

    1. Enrolled in either primary care or pulmonary clinic at the VA
    2. Seen at least once in the past year in either primary care or pulmonary clinic
  4. No COPD exacerbations in last 4 weeks
  5. English-speaking
  6. Access to telephone

Exclusion Criteria:

  1. Primary clinical diagnosis of asthma
  2. Medical conditions affecting the ability to participate in the study such as:

    1. Comorbid illness likely to limit life expectancy < 1 year
    2. Decompensated heart failure
    3. Dementia
    4. Uncontrolled psychiatric illness
  3. Participation in another clinical intervention trial in the previous 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395083

  Show 22 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Vincent S. Fan, MD MPH VA Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00395083     History of Changes
Other Study ID Numbers: 560
Study First Received: November 1, 2006
Results First Received: August 4, 2014
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bronchitis
Emphysema
Pulmonary Emphysema
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on August 28, 2014