A Menopause Interactive Decision Aid System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345072
Recruitment Status : Unknown
Verified June 2006 by Rhode Island Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2006
Last Update Posted : June 27, 2006
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
Rhode Island Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menopause Device: Web-based decision aid system Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: A Menopause Interactive Decision Aid System
Study Start Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Primary Outcome Measures :
  1. Decisional conflict
  2. Knowledge of the benefits, risks and side effects of menopausal treatments
  3. Risk perception for breast cancer, CHD, and hip fracture
  4. Patient-physician communication
  5. Satisfaction with decision
  6. Anxiety
  7. Depression
  8. Quality of menopausal counseling
  9. Adherence to medication and lifestyle changes
  10. Health-related quality of life
  11. Menopause-specific quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345072

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Nananda F Col, MD, MPH, MPP Rhode Island Hospital Identifier: NCT00345072     History of Changes
Other Study ID Numbers: R01HS013329-02 ( U.S. AHRQ Grant/Contract )
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 27, 2006
Last Verified: June 2006

Keywords provided by Rhode Island Hospital:
Decision aids
Hormone Replacement Therapy
Breast Cancer
Cardiovascular Disease