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Measuring Quality of Decisions About Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01152307
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Depression
Intervention Behavioral: DVD/Booklet: Coping with Symptoms of Depression
Enrollment 405
Recruitment Details 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 Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.
Arm/Group Title Decision Aid Control
Hide Arm/Group Description Group receiving the decision aid (DVD/booklet) Group not receiving the decision aid (DVD/booklet)
Period Title: Overall Study
Started 191 214
Completed 191 214
Not Completed 0 0
Arm/Group Title Decision Aid Control Total
Hide Arm/Group Description Group receiving the decision aid (DVD/booklet) Group not receiving the decision aid (DVD/booklet) Total of all reporting groups
Overall Number of Baseline Participants 191 214 405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 214 participants 405 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
186
  97.4%
209
  97.7%
395
  97.5%
>=65 years
5
   2.6%
5
   2.3%
10
   2.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 214 participants 405 participants
39.5  (13.4) 43.5  (16.8) 42  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 214 participants 405 participants
Female
122
  63.9%
144
  67.3%
266
  65.7%
Male
69
  36.1%
70
  32.7%
139
  34.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 191 participants 214 participants 405 participants
191 214 405
1.Primary Outcome
Title Depression Knowledge
Hide Description Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).
Time Frame 2 weeks, on average
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to receive the DVD and booklet.
Arm/Group Title Decision Aid Control
Hide Arm/Group Description:
Group receiving the decision aid (DVD/booklet)
Group not receiving the decision aid (DVD/booklet)
Overall Number of Participants Analyzed 191 214
Mean (Standard Deviation)
Unit of Measure: percent of correct responses
67.0  (14.1) 63.6  (12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Control
Comments We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.42
Confidence Interval (2-Sided) 95%
0.76 to 6.09
Parameter Dispersion
Type: Standard Deviation
Value: 1.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Value Concordance
Hide Description Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Time Frame 2 weeks, on average
Outcome Measure Data Not Reported
Time Frame August 5, 2010 through January 10, 2011.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decision Aid Control
Hide Arm/Group Description Group receiving the decision aid (DVD/booklet) Group not receiving the decision aid (DVD/booklet)
All-Cause Mortality
Decision Aid Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Decision Aid Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/191 (0.00%)   0/214 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Decision Aid Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/191 (0.00%)   0/214 (0.00%) 
Those who answered fewer than half of the knowledge questions do not have a total knowledge score (primary outcome).
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
Layout table for Results Point of Contact information
Name/Title: Dr. Karen Sepucha
Organization: Massachusetts General Hospital
Phone: 617-724-3350
EMail: ksepucha@partners.org
Layout table for additonal information
Responsible Party: Carol Cosenza, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01152307     History of Changes
Other Study ID Numbers: CSR-DQ1-002
First Submitted: June 22, 2010
First Posted: June 29, 2010
Results First Submitted: June 12, 2012
Results First Posted: August 20, 2012
Last Update Posted: August 20, 2012