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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Device: Web-based decision aid system||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Menopause Interactive Decision Aid System|
|Study Start Date :||July 2003|
- 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
- Quality of menopausal counseling
- Adherence to medication and lifestyle changes
- Health-related quality of life
- Menopause-specific quality of life
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 ClinicalTrials.gov 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|
|Principal Investigator:||Nananda F Col, MD, MPH, MPP||Rhode Island Hospital|