We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Measuring Quality of Decisions About Treatment of Menopausal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01152294
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Menopause Behavioral: DVD & Booklet called: Managing Menopause

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Study Start Date : June 2010
Primary Completion Date : September 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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%)

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152294

United States, Massachusetts
Center for Survey Research - University of Massachusetts Boston
Boston, Massachusetts, United States, 02125
Sponsors and Collaborators
University of Massachusetts, Boston
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Study Director: Patricia M Gallagher, PhD Center for Survey Research/University of Massachusetts Boston
Principal Investigator: Karen R Sepucha, PhD Massachusetts General Hospital
More Information

Responsible Party: Carol Cosenza, Project Manager, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01152294     History of Changes
Other Study ID Numbers: CSR-DQ1-001
First Posted: June 29, 2010    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: August 20, 2012
Last Verified: July 2012

Keywords provided by Carol Cosenza, University of Massachusetts, Boston:
Decision making
Decision aids
Decision quality instrument