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Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151372
First received: September 6, 2005
Last updated: December 7, 2009
Last verified: December 2009
History of Changes
Results First Received: July 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pulmonary Disease, Chronic Obstructive
Major Depression
Interventions: Behavioral: Treatment Adherence Intervention
Behavioral: Enhanced Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All subjects were recruited from the Inpatient Pulmonary Rehabilitation Units of the Burke Rehabilitation Hospital and Helen Hayes Rehabilitation Hospital. Recruitment began in March 2002 and ended in January 2008.

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
Treatment Adherence Intervention In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
Enhanced Care In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.

Participant Flow:   Overall Study
    Treatment Adherence Intervention     Enhanced Care  
STARTED     67     74  
COMPLETED     38     45  
NOT COMPLETED     29     29  
Death                 12                 11  
Lost to Follow-up                 5                 5  
Too sick medically to continue                 5                 6  
Withdrawal by Subject                 7                 7  



  Baseline Characteristics
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Reporting Groups
  Description
Treatment Adherence Intervention In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
Enhanced Care In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Total Total of all reporting groups

Baseline Measures
    Treatment Adherence Intervention     Enhanced Care     Total  
Number of Participants  
[units: participants]
 		  67     74     141  
Age  
[units: years]
Mean ± Standard Deviation 		  71.24  ± 8.54     71.5  ± 8.0     71.4  ± 8.4  
Gender  
[units: participants]
 		     
Female     42     51     93  
Male     25     23     48  
Region of Enrollment  
[units: participants]
 		     
United States     67     74     141  



  Outcome Measures
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1.  Primary:   Composite Antidepressant Score Scale (CAD)   [ Time Frame: 28 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Hamilton Depression Rating Scale   [ Time Frame: 28 Weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: George S. Alexopoulos, M.D.
Organization: Weill Cornell Medical College
phone: 914-997-5767
e-mail: gsalexop@med.cornell.edu


No publications provided


Responsible Party: George S. Alexopoulos, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00151372     History of Changes
Other Study ID Numbers: 0201005319, R01HL071992-05
Study First Received: September 6, 2005
Results First Received: July 7, 2009
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board