Clinical trial NCT00345072: A Menopause Interactive Decision Aid System
Official title: A Menopause Interactive Decision Aid System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: Menopause
Decision aids
Internet
Hormone Replacement Therapy
Breast Cancer
Cardiovascular Disease
Osteoporosis
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-06-27
Enrollment: 296
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict
measure: Knowledge of the benefits, risks and side effects of menopausal treatments
measure: Risk perception for breast cancer, CHD, and hip fracture
measure: Patient-physician communication
measure: Satisfaction with decision
measure: Anxiety
measure: Depression
measure: Quality of menopausal counseling
measure: Adherence to medication and lifestyle changes
measure: Health-related quality of life
measure: Menopause-specific quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Nananda F Col, MD, MPH, MPP
role: PRINCIPAL_INVESTIGATOR
References: