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%)
COMPLETED
NA
401 participants
2 weeks, on average
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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
212 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
398 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age Continuous
|
51 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
51 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
51 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
401 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=99 Participants
|
188 participants
n=107 Participants
|
401 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, on averagePopulation: 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 averageMeasure 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
Decision Aid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place