Measuring Quality of Decisions About Treatment of Menopausal Symptoms

NCT ID: NCT01152294

Last Updated: 2012-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Menopause Decision making Decision aids Decision quality instrument

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group not receiving the decision aid (DVD and booklet)

Group Type NO_INTERVENTION

No interventions assigned to this group

Decision Aid

Group receiving the decision aid (DVD/booklet)

Group Type EXPERIMENTAL

DVD & Booklet called: Managing Menopause

Intervention Type BEHAVIORAL

DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Decision aids Shared decision making programs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Foundation for Informed Medical Decision Making

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

University of Massachusetts, Boston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carol Cosenza

Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patricia M Gallagher, PhD

Role: STUDY_DIRECTOR

University of Massachusetts, Boston

Karen R Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Survey Research - University of Massachusetts Boston

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSR-DQ1-001

Identifier Type: -

Identifier Source: org_study_id