Trial record 1 of 1124 for:    menopause
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Measuring Quality of Decisions About Treatment of Menopausal Symptoms

This study has been completed.
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT01152294
First received: June 22, 2010
Last updated: July 13, 2012
Last verified: July 2012
  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: 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 University of Massachusetts, Boston:

Primary Outcome Measures:
  • Menopause Knowledge [ Time Frame: 2 weeks, on average ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Carol Cosenza, Project Manager, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01152294     History of Changes
Other Study ID Numbers: CSR-DQ1-001
Study First Received: June 22, 2010
Results First Received: June 12, 2012
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014