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Telephone Disease Management At-Risk Drinking (TDM II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00123409
First received: July 20, 2005
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: September 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Abuse
Interventions: Behavioral: Telephone disease management
Behavioral: Usual 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1

Telephone Based care management for reducing alcohol use

Telephone disease management: Telephone based care management

Arm 2

Usual Care

Usual Care: Usual care


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     72     74  
COMPLETED     68     71  
NOT COMPLETED     4     3  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Telephone Disease Management

Telephone Based care management for reducing alcohol use

Telephone disease management: Telephone based care management

Usual Care

Usual Care

Usual Care: Usual care

Total Total of all reporting groups

Baseline Measures
    Telephone Disease Management     Usual Care     Total  
Number of Participants  
[units: participants]
  68     71     139  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 15.1     57  ± 13.9     57.1  ± 14  
Gender  
[units: participants]
     
Female     1     2     3  
Male     67     69     136  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     30     33     63  
White     38     38     76  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     68     71     139  
# of Days Drinking in last 28 days  
[units: # of days drinking]
Mean ± Standard Deviation
  19.53  ± 9.44     20.2  ± 8.12     19.9  ± 8.8  
Problems related to alcohol [1]
[units: # problems]
Mean ± Standard Deviation
  4.31  ± 5.52     4.7  ± 5.52     4.5  ± 5.52  
[1] Measure used was the Short Inventory of Problem Drinking (SIP)



  Outcome Measures
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1.  Primary:   Reduced Alcohol Use   [ Time Frame: 12 months ]

2.  Secondary:   Reduced Problems Related to Alcohol   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Oslin
Organization: Philadelphia VAMC
phone: 2158235894
e-mail: dave.oslin@upenn.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123409     History of Changes
Other Study ID Numbers: IIR 02-108
Study First Received: July 20, 2005
Results First Received: September 26, 2014
Last Updated: October 28, 2014
Health Authority: United States: Federal Government