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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: COPD
Emphysema
Intervention: Behavioral: COPD Self-management Education

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The pilot study began in July 2006, and trial recruitment began in January 2007 with 6 sites, later expanding to 20. Recruitment ended early in March 2009 due to DMC recommendations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Usual Care 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.
Comprehensive Care Management Program

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.

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.


Participant Flow:   Overall Study
    Usual Care   Comprehensive Care Management Program
STARTED   217   209 
COMPLETED   207   201 
NOT COMPLETED   10   8 
Withdrawal by Subject                6                5 
Developed another disease                4                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care 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.
Comprehensive Care Management Program

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.

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.

Total Total of all reporting groups

Baseline Measures
   Usual Care   Comprehensive Care Management Program   Total 
Overall Participants Analyzed 
[Units: Participants]
 217   209   426 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.8  (8.2)   66.2  (8.4)   66.0  (8.3) 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   209   204   413 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   5   3   8 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   20   24   44 
White   191   181   372 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   8   2   10 
Not Hispanic or Latino   209   207   416 
Unknown or Not Reported   0   0   0 


  Outcome Measures

1.  Primary:   Hospitalization-free Survival - Time to Event   [ Time Frame: From randomization until date of first hospitalization for COPD, assessed up to 26 months ]

2.  Primary:   Hazard Ratio for First COPD Hospitalization   [ Time Frame: 26 months ]

3.  Secondary:   Hazard Ratio for All-Cause Mortality   [ Time Frame: 26 months ]

4.  Secondary:   Time to All-Cause Death   [ Time Frame: From randomization until death, assessed up to 26 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sarah Leatherman
Organization: VA Boston Healthcare System - MAVERIC
phone: 857-364-4220
e-mail: sarah.leatherman@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00395083     History of Changes
Other Study ID Numbers: 560
First Submitted: November 1, 2006
First Posted: November 2, 2006
Results First Submitted: August 4, 2014
Results First Posted: August 21, 2014
Last Update Posted: September 15, 2014