This trial is active, not recruiting.

Condition menopause
Treatment web-based decision aid system
Sponsor Rhode Island Hospital
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date July 2003
Trial size 296 participants
Trial identifier NCT00345072, R01 HS13329-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose educational/counseling/training

Primary Outcomes

Decisional conflict
time frame:
Knowledge of the benefits, risks and side effects of menopausal treatments
time frame:
Risk perception for breast cancer, CHD, and hip fracture
time frame:
Patient-physician communication
time frame:
Satisfaction with decision
time frame:
time frame:
time frame:
Quality of menopausal counseling
time frame:
Adherence to medication and lifestyle changes
time frame:
Health-related quality of life
time frame:
Menopause-specific quality of life
time frame:

Eligibility Criteria

Female participants from 45 years up to 65 years old.

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

Additional Information

Official title A Menopause Interactive Decision Aid System
Principal investigator Nananda F Col, MD, MPH, MPP
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2006.
Information provided to ClinicalTrials.gov by Rhode Island Hospital.