Measuring Quality of Decisions About Treatment of Depression

This study has been completed.
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT01152307
First received: June 22, 2010
Last updated: July 13, 2012
Last verified: July 2012
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Depression
Intervention: Behavioral: DVD/Booklet: Coping with Symptoms of Depression

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C. August 5, 2010-Jan 10, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.

Reporting Groups
  Description
Decision Aid Group receiving the decision aid (DVD/booklet)
Control Group not receiving the decision aid (DVD/booklet)

Participant Flow:   Overall Study
    Decision Aid     Control  
STARTED     191     214  
COMPLETED     191     214  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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
Decision Aid Group receiving the decision aid (DVD/booklet)
Control Group not receiving the decision aid (DVD/booklet)
Total Total of all reporting groups

Baseline Measures
    Decision Aid     Control     Total  
Number of Participants  
[units: participants]
  191     214     405  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     186     209     395  
>=65 years     5     5     10  
Age  
[units: years]
Mean ± Standard Deviation
  39.5  ± 13.4     43.5  ± 16.8     42  ± 15.4  
Gender  
[units: participants]
     
Female     122     144     266  
Male     69     70     139  
Region of Enrollment  
[units: participants]
     
United States     191     214     405  



  Outcome Measures

1.  Primary:   Depression Knowledge   [ Time Frame: 2 weeks, on average ]

2.  Secondary:   Value Concordance   [ Time Frame: 2 weeks, on average ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Those who answered fewer than half of the knowledge questions do not have a total knowledge score (primary outcome).


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Karen Sepucha
Organization: Massachusetts General Hospital
phone: 617-724-3350
e-mail: ksepucha@partners.org


No publications provided


Responsible Party: Carol Cosenza, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01152307     History of Changes
Other Study ID Numbers: CSR-DQ1-002
Study First Received: June 22, 2010
Results First Received: June 12, 2012
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board