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A Menopause Interactive Decision Aid System

45 Years
65 Years
Open (Enrolling)

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Trial Information

A Menopause Interactive Decision Aid System

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.

Inclusion Criteria:

- English-speaking

- Between 45 and 65 years of age

- Patient at participating clinics

- Experience menopausal symptoms or being 6 months or more past last menstrual period

- Have an upcoming appointment for menopausal counseling or annual physical exam (only
applicable for clinical trial participants)

Exclusion Criteria:

- Inability to give informed consent

- Dementia

- Age over 65 years

- Pre-existing terminal illness that limits life expectancy to less than 2 years

- History of breast cancer or cardiovascular disease

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Decisional conflict

Principal Investigator

Nananda F Col, MD, MPH, MPP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rhode Island Hospital


United States: Institutional Review Board

Study ID:

R01 HS13329-02



Start Date:

July 2003

Completion Date:

Related Keywords:

  • Menopause
  • Menopause
  • Decision aids
  • Internet
  • Hormone Replacement Therapy
  • Breast Cancer
  • Cardiovascular Disease
  • Osteoporosis



Rhode Island Hospital Providence, Rhode Island  02903
Brigham and Women's Hospital Boston, Massachusetts  02115