Measuring Quality of Decisions About Treatment of Menopausal Symptoms

University of Massachusetts, Worcester

Status: Completed

Conditions: Menopause

Treatments: Behavioral: DVD & Booklet called: Managing Menopause

Study type: Interventional

Funder types: Other

Identifiers

NCT01152294

CSR-DQ1-001

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

401 participants in 2 patient groups

Control

No Intervention group

Description:

Group not receiving the decision aid (DVD and booklet)

Decision Aid

Experimental group

Description:

Group receiving the decision aid (DVD/booklet)

Treatment:

Behavioral: DVD & Booklet called: Managing Menopause