Menopause Clinical Trial
Official title:
A Menopause Interactive Decision Aid System
The purpose of this study is to develop and test a web-based system intended to help women going through menopause make more informed choices regarding menopause treatments. The system will do this by giving women personalized feedback on the risks and benefits of these treatments.
Most women are not satisfied with the counseling they receive about menopause. To improve
menopause counseling and help menopausal women more actively participate in the decision
making process, we have developed a novel prototype web-based decision aid. Our immediate
goal is to develop this prototype technology into a comprehensive Menopause Interactive
Decision Aid System (MIDAS) that provides personalized feedback about menopausal symptoms,
risks for common conditions, and the effects of different treatment options on the short-
and long-term consequences of menopause.
Our main study hypotheses are that MIDAS can: 1) lead to better decisions and improve the
quality of menopausal counseling; 2) improve compliance with a chosen menopausal plan; and
3) reduce medical errors associated with the use of menopausal therapies.
We propose a 2-phase study conducted over 3 years. Phase I will transform the prototype
application into a comprehensive MIDAS, completing its content and risk assessment
instruments, and exploring its optimal design. This will be accomplished through conduct of
focus groups and usability tests. Phase II will formally evaluate the impact of MIDAS in a
randomized, controlled, multi-center clinical trial involving diverse patient populations
and clinician settings. We will measure the impact of MIDAS on the decision-making process
as well as its effect on providers and outcome measures related to menopause, including
compliance, quality of life, and medical errors related to menopausal therapy. Analyses will
evaluate the extent to which the impact of MIDAS on these outcomes varies according to
patient, practice, and physician characteristics.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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