Measuring Quality of Decisions About Treatment of Menopausal Symptoms

July 13, 2012 updated by: Carol Cosenza, University of Massachusetts, Boston
The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of menopause. In particular, we will examine whether the decision aid increases knowledge about menopause/managing menopause symptoms and concordance between goals and treatment choices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02125
        • Center for Survey Research - University of Massachusetts Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, aged 40-60
  • Talked with health care provider about ways to manage menopause within last year OR seriously considered taking medicine or supplement to manage menopause within the last year

Exclusion Criteria:

  • Prior diagnosis of breast cancer
  • Surgical or medically induced menopause (ovaries removed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Group not receiving the decision aid (DVD and booklet)
EXPERIMENTAL: Decision Aid
Group receiving the decision aid (DVD/booklet)
Behavioral: DVD & Booklet called: Managing Menopause
DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms
Other Names:
  • Decision aids
  • Shared decision making programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopause Knowledge
Time Frame: 2 weeks, on average
Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)
2 weeks, on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value Concordance
Time Frame: 2 weeks, on average
Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs
2 weeks, on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Boston

Collaborators

Massachusetts General Hospital
Foundation for Informed Medical Decision Making

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (ESTIMATE)

June 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSR-DQ1-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on DVD & Booklet called: Managing Menopause

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