A Menopause Interactive Decision Aid System

Menopause Clinical Trial

Official title:

A Menopause Interactive Decision Aid System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00345072
• Other study ID #: R01HS013329-02
• Status: Active, not recruiting
• Phase: N/A
• First received: June 26, 2006
• Last updated: June 26, 2006
• Start date: July 2003

Study information

• Verified date: June 2006
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Menopause

Intervention

Device:
• Web-based decision aid system

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict
Primary	Knowledge of the benefits, risks and side effects of menopausal treatments
Primary	Risk perception for breast cancer, CHD, and hip fracture
Primary	Patient-physician communication
Primary	Satisfaction with decision
Primary	Anxiety
Primary	Depression
Primary	Quality of menopausal counseling
Primary	Adherence to medication and lifestyle changes
Primary	Health-related quality of life
Primary	Menopause-specific quality of life