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Measuring Quality of Decisions About Treatment of Menopausal Symptoms

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ClinicalTrials.gov Identifier: NCT01152294
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston

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 Phase
Menopause Behavioral: DVD & Booklet called: Managing Menopause Not Applicable

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
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




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



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

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)

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


Locations
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
Investigators
Study Director: Patricia M Gallagher, PhD Center for Survey Research/University of Massachusetts Boston
Principal Investigator: Karen R Sepucha, PhD Massachusetts General Hospital

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:
Menopause
Decision making
Decision aids
Decision quality instrument