Trial Outcomes & Findings for Measuring Quality of Decisions About Treatment of Depression (NCT NCT01152307)

Results Overview

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%).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

405 participants

Primary outcome timeframe

2 weeks, on average

Results posted on

2012-08-20

Participant Flow

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.

Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.

Participant milestones

Participant milestones
Measure	Decision Aid Group receiving the decision aid (DVD/booklet)	Control Group not receiving the decision aid (DVD/booklet)
Overall Study STARTED	191	214
Overall Study COMPLETED	191	214
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Quality of Decisions About Treatment of Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid n=191 Participants Group receiving the decision aid (DVD/booklet)	Control n=214 Participants Group not receiving the decision aid (DVD/booklet)	Total n=405 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	186 Participants n=5 Participants	209 Participants n=7 Participants	395 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	39.5 years STANDARD_DEVIATION 13.4 • n=5 Participants	43.5 years STANDARD_DEVIATION 16.8 • n=7 Participants	42 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	144 Participants n=7 Participants	266 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	70 Participants n=7 Participants	139 Participants n=5 Participants
Region of Enrollment United States	191 participants n=5 Participants	214 participants n=7 Participants	405 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks, on average

Population: Participants were randomized to receive the DVD and booklet.

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%).

Outcome measures

Outcome measures
Measure	Decision Aid n=191 Participants Group receiving the decision aid (DVD/booklet)	Control n=214 Participants Group not receiving the decision aid (DVD/booklet)
Depression Knowledge	67.0 percent of correct responses Standard Deviation 14.1	63.6 percent of correct responses Standard Deviation 12.5

SECONDARY outcome

Timeframe: 2 weeks, on average

Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs

Outcome measures

Outcome data not reported

Adverse Events

Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Sepucha

Massachusetts General Hospital

Phone: 617-724-3350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place