Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345072
Status:
UNKNOWN
Last Update Posted:
2006-06-27
First Post:
2006-06-26
Brief Title:
A Menopause Interactive Decision Aid System
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
A Menopause Interactive Decision Aid System
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None