Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- Menopause Knowledge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- 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)
Arms & Interventions
Control
Group not receiving the decision aid (DVD and booklet)
Decision Aid
Group receiving the decision aid (DVD/booklet)
Intervention: DVD & Booklet called: Managing Menopause (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Value Concordance(2 weeks, on average)
Investigators
Carol Cosenza
Project Manager
University of Massachusetts, Boston