Menopause
Conditions
Keywords
Menopause, Decision aids, Internet, Hormone Replacement Therapy, Breast Cancer, Cardiovascular Disease, Osteoporosis
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.
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.
Interventions
DEVICEWeb-based decision aid system
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decisional conflict | — |
| Knowledge of the benefits, risks and side effects of menopausal treatments | — |
| Risk perception for breast cancer, CHD, and hip fracture | — |
| Patient-physician communication | — |
| Satisfaction with decision | — |
| Anxiety | — |
| Depression | — |
| Quality of menopausal counseling | — |
| Adherence to medication and lifestyle changes | — |
| Health-related quality of life | — |
| Menopause-specific quality of life | — |
Countries
United States
Outcome results
None listed