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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
Enrollment 426
Recruitment Details 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  
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 217 209
Completed 207 201
Not Completed 10 8
Reason Not Completed
Withdrawal by Subject             6             5
Developed another disease             4             3
Arm/Group Title Usual Care Comprehensive Care Management Program Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 217 209 426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 209 participants 426 participants
65.8  (8.2) 66.2  (8.4) 66.0  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 209 participants 426 participants
Female
8
   3.7%
5
   2.4%
13
   3.1%
Male
209
  96.3%
204
  97.6%
413
  96.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 209 participants 426 participants
American Indian or Alaska Native
5
   2.3%
3
   1.4%
8
   1.9%
Asian
1
   0.5%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.5%
1
   0.2%
Black or African American
20
   9.2%
24
  11.5%
44
  10.3%
White
191
  88.0%
181
  86.6%
372
  87.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 209 participants 426 participants
Hispanic or Latino
8
   3.7%
2
   1.0%
10
   2.3%
Not Hispanic or Latino
209
  96.3%
207
  99.0%
416
  97.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Hospitalization-free Survival - Time to Event
Hide Description [Not Specified]
Time Frame From randomization until date of first hospitalization for COPD, assessed up to 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 217 209
Median (95% Confidence Interval)
Unit of Measure: years
0.45
(0.36 to 0.53)
0.46
(0.39 to 0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Comprehensive Care Management Program
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.70 to 1.80
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hazard Ratio for First COPD Hospitalization
Hide Description [Not Specified]
Time Frame 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 217 209
Measure Type: Number
Unit of Measure: participants
Subjects with COPD Hospitalization 34 36
Subjects without COPD Hospitalization 183 173
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Comprehensive Care Management Program
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.70 to 1.80
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Hazard Ratio for All-Cause Mortality
Hide Description [Not Specified]
Time Frame 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 217 209
Measure Type: Number
Unit of Measure: participants
All-Cause Death 10 28
Alive 207 181
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Comprehensive Care Management Program
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.00
Confidence Interval (2-Sided) 95%
1.46 to 6.17
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to All-Cause Death
Hide Description [Not Specified]
Time Frame From randomization until death, assessed up to 26 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 217 209
Median (95% Confidence Interval)
Unit of Measure: years
0.51
(0.43 to 0.79)
0.49
(0.40 to 0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Comprehensive Care Management Program
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.00
Confidence Interval (2-Sided) 95%
1.46 to 6.17
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Non-serious adverse events were not collected for this study.
 
Arm/Group Title Usual Care Comprehensive Care Management Program
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Usual Care Comprehensive Care Management Program
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Comprehensive Care Management Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/217 (45.16%)      91/209 (43.54%)    
Blood and lymphatic system disorders     
Anaemia  1/217 (0.46%)  1 1/209 (0.48%)  1
Thrombocytopenia  0/217 (0.00%)  0 2/209 (0.96%)  2
Cardiac disorders     
Angina pectoris  2/217 (0.92%)  2 0/209 (0.00%)  0
Angina unstable  1/217 (0.46%)  1 0/209 (0.00%)  0
Arteriosclerosis coronary artery  1/217 (0.46%)  1 0/209 (0.00%)  0
Atrial fibrillation  1/217 (0.46%)  1 2/209 (0.96%)  5
Atrial flutter  0/217 (0.00%)  0 1/209 (0.48%)  1
Cardiac failure congestive  2/217 (0.92%)  2 8/209 (3.83%)  12
Myocardial infarction  4/217 (1.84%)  4 3/209 (1.44%)  3
Myocardial ischaemia  0/217 (0.00%)  0 1/209 (0.48%)  1
Tachycardia  1/217 (0.46%)  1 0/209 (0.00%)  0
Cardiac arrest  0/217 (0.00%)  0 1/209 (0.48%)  1
Cardiac disorder  1/217 (0.46%)  1 0/209 (0.00%)  0
Cardiac failure  0/217 (0.00%)  0 1/209 (0.48%)  1
Gastrointestinal disorders     
Abdominal pain upper  0/217 (0.00%)  0 1/209 (0.48%)  1
Colitis ischaemic  2/217 (0.92%)  2 0/209 (0.00%)  0
Diarrhoea  0/217 (0.00%)  0 1/209 (0.48%)  1
Duodenal ulcer  1/217 (0.46%)  1 0/209 (0.00%)  0
Gastritis erosive  0/217 (0.00%)  0 1/209 (0.48%)  1
Gastrointestinal haemorrhage  1/217 (0.46%)  1 3/209 (1.44%)  4
Gastrooesophageal reflux disease  1/217 (0.46%)  1 0/209 (0.00%)  0
Intestinal infarction  1/217 (0.46%)  1 0/209 (0.00%)  0
Pneumatosis intestinalis  0/217 (0.00%)  0 1/209 (0.48%)  1
Volvulus  1/217 (0.46%)  1 0/209 (0.00%)  0
Non-cardiac chest pain  1/217 (0.46%)  1 0/209 (0.00%)  0
Inguinal hernia  1/217 (0.46%)  1 0/209 (0.00%)  0
Intestinal obstruction  0/217 (0.00%)  0 1/209 (0.48%)  1
Vomiting  1/217 (0.46%)  1 0/209 (0.00%)  0
General disorders     
Adverse drug reaction  2/217 (0.92%)  2 0/209 (0.00%)  0
Chest discomfort  0/217 (0.00%)  0 1/209 (0.48%)  1
Chest pain  7/217 (3.23%)  7 4/209 (1.91%)  4
Death  3/217 (1.38%)  3 6/209 (2.87%)  6
Fatigue  1/217 (0.46%)  1 0/209 (0.00%)  0
Hernia  1/217 (0.46%)  1 0/209 (0.00%)  0
Oedema peripheral  0/217 (0.00%)  0 1/209 (0.48%)  1
Asthenia  0/217 (0.00%)  0 1/209 (0.48%)  1
Hepatobiliary disorders     
Cholangitis  1/217 (0.46%)  1 0/209 (0.00%)  0
Liver injury  0/217 (0.00%)  0 1/209 (0.48%)  1
Hepatitis alcoholic  1/217 (0.46%)  1 0/209 (0.00%)  0
Infections and infestations     
Bacteraemia  0/217 (0.00%)  0 1/209 (0.48%)  1
Cellulitis  2/217 (0.92%)  2 2/209 (0.96%)  3
Clostridium difficile colitis  0/217 (0.00%)  0 2/209 (0.96%)  2
Diverticulitis  1/217 (0.46%)  1 0/209 (0.00%)  0
Escherichia bacteraemia  0/217 (0.00%)  0 1/209 (0.48%)  1
Infective exacerbation of chronic obstructive  1/217 (0.46%)  1 0/209 (0.00%)  0
Lung infection pseudomonal  1/217 (0.46%)  1 0/209 (0.00%)  0
Pneumonia  17/217 (7.83%)  19 17/209 (8.13%)  21
Prostate infection  0/217 (0.00%)  0 1/209 (0.48%)  1
Rhinitis  0/217 (0.00%)  0 1/209 (0.48%)  1
Urinary tract infection  0/217 (0.00%)  0 1/209 (0.48%)  1
Urinary tract infection staphylococal  0/217 (0.00%)  0 1/209 (0.48%)  1
Gastroenteritis viral  1/217 (0.46%)  1 0/209 (0.00%)  0
Gastrointestinal infection  0/217 (0.00%)  0 1/209 (0.48%)  1
Injury, poisoning and procedural complications     
Fall  1/217 (0.46%)  1 3/209 (1.44%)  4
Overdose  0/217 (0.00%)  0 1/209 (0.48%)  1
Post procedural complication  1/217 (0.46%)  1 0/209 (0.00%)  0
Procedural complication  3/217 (1.38%)  3 1/209 (0.48%)  1
Road traffic accident  1/217 (0.46%)  1 1/209 (0.48%)  1
Splenic rupture  1/217 (0.46%)  1 0/209 (0.00%)  0
Wound dehiscence  0/217 (0.00%)  0 1/209 (0.48%)  1
Wound complication  0/217 (0.00%)  0 1/209 (0.48%)  1
Investigations     
Biopsy lung  1/217 (0.46%)  1 0/209 (0.00%)  0
Blood glucose increased  0/217 (0.00%)  0 1/209 (0.48%)  1
Tuberculin test positive  1/217 (0.46%)  1 0/209 (0.00%)  0
International normalised ratio increased  0/217 (0.00%)  0 2/209 (0.96%)  2
Metabolism and nutrition disorders     
Dehydration  1/217 (0.46%)  1 1/209 (0.48%)  1
Diabetes mellitus  1/217 (0.46%)  1 0/209 (0.00%)  0
Fluid overload  0/217 (0.00%)  0 1/209 (0.48%)  2
Gout  0/217 (0.00%)  0 1/209 (0.48%)  1
Hyperglycaemia  0/217 (0.00%)  0 1/209 (0.48%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  0/217 (0.00%)  0 1/209 (0.48%)  1
Bursitis  0/217 (0.00%)  0 1/209 (0.48%)  1
Myalgia  0/217 (0.00%)  0 1/209 (0.48%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1/217 (0.46%)  1 1/209 (0.48%)  1
Oesophageal adenocarcinoma  0/217 (0.00%)  0 1/209 (0.48%)  1
Prostate cancer  0/217 (0.00%)  0 1/209 (0.48%)  1
Nervous system disorders     
Aphasia  0/217 (0.00%)  0 1/209 (0.48%)  1
Carotid artery stenosis  0/217 (0.00%)  0 1/209 (0.48%)  1
Syncope  1/217 (0.46%)  1 0/209 (0.00%)  0
Psychiatric disorders     
Aggression  0/217 (0.00%)  0 1/209 (0.48%)  1
Anxiety disorder  1/217 (0.46%)  1 0/209 (0.00%)  0
Confusional state  1/217 (0.46%)  1 0/209 (0.00%)  0
Depression  1/217 (0.46%)  1 0/209 (0.00%)  0
Drug abuse  1/217 (0.46%)  1 0/209 (0.00%)  0
Mental status changes  1/217 (0.46%)  1 0/209 (0.00%)  0
Panic attack  1/217 (0.46%)  1 0/209 (0.00%)  0
Alocholism  1/217 (0.46%)  2 0/209 (0.00%)  0
Renal and urinary disorders     
Bladder mass  0/217 (0.00%)  0 1/209 (0.48%)  1
Pollakiuria  0/217 (0.00%)  0 1/209 (0.48%)  1
Renal failure acute  2/217 (0.92%)  2 1/209 (0.48%)  1
Urinary retention  1/217 (0.46%)  1 0/209 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  0/217 (0.00%)  0 1/209 (0.48%)  1
Erectile dysfunction  1/217 (0.46%)  1 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  2/217 (0.92%)  3 3/209 (1.44%)  3
Asthma  0/217 (0.00%)  0 1/209 (0.48%)  1
Chronic obstructive pulmonary disease  53/217 (24.42%)  84 42/209 (20.10%)  65
Dyspnoea  4/217 (1.84%)  5 4/209 (1.91%)  5
Epistaxis  0/217 (0.00%)  0 2/209 (0.96%)  2
Hypoxia  1/217 (0.46%)  1 0/209 (0.00%)  0
Interstitial lung disease  1/217 (0.46%)  1 0/209 (0.00%)  0
Pleural effusion  0/217 (0.00%)  0 2/209 (0.96%)  2
Pulmonary fibrosis  1/217 (0.46%)  1 0/209 (0.00%)  0
Pulmonary hypertension  0/217 (0.00%)  0 1/209 (0.48%)  1
Respiratory distress  0/217 (0.00%)  0 1/209 (0.48%)  1
Respiratory failure  5/217 (2.30%)  5 1/209 (0.48%)  1
Haemoptysis  0/217 (0.00%)  0 1/209 (0.48%)  1
Pneumonia aspiration  0/217 (0.00%)  0 1/209 (0.48%)  1
Pneumothorax  1/217 (0.46%)  1 0/209 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer  0/217 (0.00%)  0 1/209 (0.48%)  1
Social circumstances     
Physical assault  0/217 (0.00%)  0 1/209 (0.48%)  2
Surgical and medical procedures     
Angioplasty  1/217 (0.46%)  1 0/209 (0.00%)  0
Bladder operation  1/217 (0.46%)  1 0/209 (0.00%)  0
Cardiac pacemaker insertion  0/217 (0.00%)  0 1/209 (0.48%)  1
Carotid endarterectomy  0/217 (0.00%)  0 1/209 (0.48%)  1
Colectomy  1/217 (0.46%)  1 0/209 (0.00%)  0
Hospitalisation  1/217 (0.46%)  1 0/209 (0.00%)  0
Implantable defibrillator insertion  1/217 (0.46%)  1 1/209 (0.48%)  1
Knee arthroplasty  0/217 (0.00%)  0 1/209 (0.48%)  1
Palliative care  0/217 (0.00%)  0 1/209 (0.48%)  1
Preoperative care  0/217 (0.00%)  0 1/209 (0.48%)  1
Surgery  1/217 (0.46%)  1 0/209 (0.00%)  0
Vascular disorders     
Aortic aneurysm  0/217 (0.00%)  0 3/209 (1.44%)  3
Aortic aneurysm rupture  0/217 (0.00%)  0 1/209 (0.48%)  1
Deep vein thrombosis  1/217 (0.46%)  1 0/209 (0.00%)  0
Hypertension  0/217 (0.00%)  0 1/209 (0.48%)  1
Peripheral vascular disorder  1/217 (0.46%)  2 0/209 (0.00%)  0
Subclavian artery stenosis  0/217 (0.00%)  0 1/209 (0.48%)  1
Orthostatic hypotension  0/217 (0.00%)  0 1/209 (0.48%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Comprehensive Care Management Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
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
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