Trial Outcomes & Findings for Measuring Quality of Decisions About Treatment of Menopausal Symptoms (NCT NCT01152294)

NCT ID: NCT01152294

Last Updated: 2012-08-20

Results Overview

Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 401 participants
• Primary outcome timeframe: 2 weeks, on average
• Results posted on: 2012-08-20

Participant Flow

Participants 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.

Participants were randomized to receive a DVD and booklet or no DVD and to participate by phone or IVR (automated telephone survey system).

Participant milestones

Measure	Control Group not receiving the decision aid (DVD and booklet)	Decision Aid Group receiving the decision aid (DVD/booklet)
Overall Study STARTED	213	188
Overall Study COMPLETED	213	188
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Quality of Decisions About Treatment of Menopausal Symptoms

Baseline characteristics by cohort

Measure	Control n=213 Participants Group not receiving the decision aid (DVD and booklet)	Decision Aid n=188 Participants Group receiving the decision aid (DVD/booklet)	Total n=401 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	212 Participants n=5 Participants	186 Participants n=7 Participants	398 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 5.1 • n=5 Participants	51 years STANDARD_DEVIATION 5.5 • n=7 Participants	51 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	213 Participants n=5 Participants	188 Participants n=7 Participants	401 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	213 participants n=5 Participants	188 participants n=7 Participants	401 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks, on average

Population: Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.

Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)

Outcome measures

Measure	Control n=199 Participants Group not receiving the decision aid (DVD and booklet)	Decision Aid n=182 Participants Group receiving the decision aid (DVD/booklet)
Menopause Knowledge	51.3 Percentage (0-100%) Standard Deviation 16.0	55.8 Percentage (0-100%) Standard Deviation 18.4

SECONDARY outcome

Timeframe: 2 weeks, on average

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

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decision Aid

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

Karen Sepucha, Ph.D.

Massachusetts General Hospital

Phone: 617-724-3350

Email: ksepucha@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place