NCT00345072

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
Last Updated

June 27, 2006

Status Verified

June 1, 2006

First QC Date

June 26, 2006

Last Update Submit

June 26, 2006

Conditions

Menopause

Keywords

MenopauseDecision aidsInternetHormone Replacement TherapyBreast CancerCardiovascular DiseaseOsteoporosis

Outcome Measures

Primary Outcomes (11)

  • 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

Interventions

Web-based decision aid systemDEVICE

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCardiovascular DiseasesOsteoporosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nananda F Col, MD, MPH, MPP

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

July 1, 2003

Last Updated

June 27, 2006

Record last verified: 2006-06

Locations

US(2)