Measuring Quality of Decisions About Treatment of Menopausal Symptoms

Menopause Clinical Trial

Official title:

Measuring Quality of Decisions About Treatment of Menopausal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152294
• Other study ID #: CSR-DQ1-001
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: July 13, 2012
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: July 2012
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Menopause

Intervention

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

Locations

Country	Name	City	State
United States	Center for Survey Research - University of Massachusetts Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Boston	Foundation for Informed Medical Decision Making, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause Knowledge	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	No
Secondary	Value Concordance	Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs	2 weeks, on average	No