Measuring Quality of Decisions About Treatment of Menopausal Symptoms
1 other identifier
interventional
401
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
August 20, 2012
CompletedAugust 20, 2012
July 1, 2012
3 months
June 22, 2010
June 12, 2012
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Value Concordance
2 weeks, on average
Study Arms (2)
Control
NO INTERVENTIONGroup not receiving the decision aid (DVD and booklet)
Decision Aid
EXPERIMENTALGroup receiving the decision aid (DVD/booklet)
Interventions
DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior diagnosis of breast cancer
- Surgical or medically induced menopause (ovaries removed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Bostonlead
- Foundation for Informed Medical Decision Makingcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Center for Survey Research - University of Massachusetts Boston
Boston, Massachusetts, 02125, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participants who answered less than half the knowledge questions do not have a total knowledge score (primary outcome).
Results Point of Contact
- Title
- Karen Sepucha, Ph.D.
- Organization
- Massachusetts General Hospital
Study Officials
- STUDY DIRECTOR
Patricia M Gallagher, PhD
University of Massachusetts, Boston
- PRINCIPAL INVESTIGATOR
Karen R Sepucha, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Manager
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 29, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
August 20, 2012
Results First Posted
August 20, 2012
Record last verified: 2012-07