A Menopause Interactive Decision Aid System

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Menopause Interactive Decision Aid System

Conditions
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Menopause

Intervention / Treatment
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* Device: Web-based decision aid system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Web-based decision aid system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Decision aids, Internet, Hormone Replacement Therapy, Breast Cancer, Cardiovascular Disease, Osteoporosis