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Measuring Quality of Decisions About Treatment of Menopausal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152294
First Posted: June 29, 2010
Last Update Posted: August 20, 2012
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.
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston
  Purpose
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 Intervention
Menopause Behavioral: DVD & Booklet called: Managing Menopause

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Carol Cosenza, University of Massachusetts, Boston:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 401
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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)
  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


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
  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 Submitted: June 22, 2010
First Posted: June 29, 2010
Results First Submitted: June 12, 2012
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