A Menopause Interactive Decision Aid System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Rhode Island Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00345072
First received: June 26, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Menopause
Device: Web-based decision aid system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Menopause Interactive Decision Aid System

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 296
Study Start Date: July 2003
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

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345072

Locations
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
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Nananda F Col, MD, MPH, MPP Rhode Island Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345072     History of Changes
Other Study ID Numbers: R01 HS13329-02
Study First Received: June 26, 2006
Last Updated: June 26, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Menopause
Decision aids
Internet
Hormone Replacement Therapy
Breast Cancer
Cardiovascular Disease
Osteoporosis

ClinicalTrials.gov processed this record on April 17, 2014