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| Name | Class |
|---|---|
| Foundation for Informed Medical Decision Making | OTHER |
| Massachusetts General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Group not receiving the decision aid (DVD and booklet) | |
| Decision Aid | Experimental | Group receiving the decision aid (DVD/booklet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVD & Booklet called: Managing Menopause | Behavioral | DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Value Concordance | Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs | 2 weeks, on average |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia M Gallagher, PhD | University of Massachusetts, Boston | Study Director |
| Karen R Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Survey Research - University of Massachusetts Boston | Boston | Massachusetts | 02125 | United States |
Participants were randomized to receive a DVD and booklet or no DVD and to participate by phone or IVR (automated telephone survey system).
Participants were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Group not receiving the decision aid (DVD and booklet) |
| FG001 | Decision Aid | Group receiving the decision aid (DVD/booklet) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Group not receiving the decision aid (DVD and booklet) |
| BG001 | Decision Aid | Group receiving the decision aid (DVD/booklet) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%) | Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet. | Posted | Mean | Standard Deviation | Percentage (0-100%) | 2 weeks, on average |
|
August 10, 2010 to December 2, 2010
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Group not receiving the decision aid (DVD and booklet) |
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Participants who answered less than half the knowledge questions do not have a total knowledge score (primary outcome).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha, Ph.D. | Massachusetts General Hospital | 617-724-3350 | ksepucha@partners.org |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Value Concordance | Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs | Not Posted | 2 weeks, on average |
| 0 |
| 213 |
| 0 |
| 213 |
| EG001 | Decision Aid | Group receiving the decision aid (DVD/booklet) | 0 | 188 | 0 | 188 |
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