Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT01152294
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2010-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measuring Quality of Decisions About Treatment of Menopausal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ksepucha@partners.org', 'phone': '617-724-3350', 'title': 'Karen Sepucha, Ph.D.', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants who answered less than half the knowledge questions do not have a total knowledge score (primary outcome).'}}, 'adverseEventsModule': {'timeFrame': 'August 10, 2010 to December 2, 2010', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Group not receiving the decision aid (DVD and booklet)', 'otherNumAtRisk': 213, 'otherNumAffected': 0, 'seriousNumAtRisk': 213, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Decision Aid', 'description': 'Group receiving the decision aid (DVD/booklet)', 'otherNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 188, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Menopause Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Group not receiving the decision aid (DVD and booklet)'}, {'id': 'OG001', 'title': 'Decision Aid', 'description': 'Group receiving the decision aid (DVD/booklet)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '55.8', 'spread': '18.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '1.02', 'ciUpperLimit': '7.96', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.4', 'groupDescription': 'We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, on average', 'description': '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%)', 'unitOfMeasure': 'Percentage (0-100%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.'}, {'type': 'SECONDARY', 'title': 'Value Concordance', 'timeFrame': '2 weeks, on average', 'description': "Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs", 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Group not receiving the decision aid (DVD and booklet)'}, {'id': 'FG001', 'title': 'Decision Aid', 'description': 'Group receiving the decision aid (DVD/booklet)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Participants were randomized to receive a DVD and booklet or no DVD and to participate by phone or IVR (automated telephone survey system).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Group not receiving the decision aid (DVD and booklet)'}, {'id': 'BG001', 'title': 'Decision Aid', 'description': 'Group receiving the decision aid (DVD/booklet)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '51', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '51', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-13', 'studyFirstSubmitDate': '2010-06-22', 'resultsFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2010-06-25', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-13', 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menopause Knowledge', 'timeFrame': '2 weeks, on average', 'description': '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%)'}], 'secondaryOutcomes': [{'measure': 'Value Concordance', 'timeFrame': '2 weeks, on average', 'description': "Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menopause', 'Decision making', 'Decision aids', 'Decision quality instrument'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, aged 40-60\n* 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\n\nExclusion Criteria:\n\n* Prior diagnosis of breast cancer\n* Surgical or medically induced menopause (ovaries removed)'}, 'identificationModule': {'nctId': 'NCT01152294', 'briefTitle': 'Measuring Quality of Decisions About Treatment of Menopausal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Boston'}, 'officialTitle': 'Measuring Quality of Decisions About Treatment of Menopausal Symptoms', 'orgStudyIdInfo': {'id': 'CSR-DQ1-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Group not receiving the decision aid (DVD and booklet)'}, {'type': 'EXPERIMENTAL', 'label': 'Decision Aid', 'description': 'Group receiving the decision aid (DVD/booklet)', 'interventionNames': ['Behavioral: DVD & Booklet called: Managing Menopause']}], 'interventions': [{'name': 'DVD & Booklet called: Managing Menopause', 'type': 'BEHAVIORAL', 'otherNames': ['Decision aids', 'Shared decision making programs'], 'description': 'DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms', 'armGroupLabels': ['Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02125', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Center for Survey Research - University of Massachusetts Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Patricia M Gallagher, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Massachusetts, Boston'}, {'name': 'Karen R Sepucha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Informed Medical Decision Making', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Carol Cosenza', 'investigatorAffiliation': 'University of Massachusetts, Boston'}}}}