Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT00983333
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-11-01', 'releaseDate': '2019-10-14'}], 'estimatedResultsFirstSubmitDate': '2019-10-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interpersonal communication knowledge, attitudes and behaviors exhibeted by patients and health care professionals during a patient-provider office visit', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient and health care professional satisfaction with communication', 'timeFrame': '2 weeks'}, {'measure': 'Change in patient average blood pressure', 'timeFrame': '6 months'}, {'measure': 'Change in serum hemoglobin A1c value among patients with diabetes', 'timeFrame': '6 months'}, {'measure': 'change in average appointment length for health care professionals', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health communication', 'Health literacy', 'Patient', 'Health Care Professional', 'Satisfaction'], 'conditions': ['Cardiovascular Disease', 'Cardiovascular Risk Factors']}, 'descriptionModule': {'briefSummary': 'This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues.\n\nThis pilot (or Beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. The investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals.\n\nParticipants in this research study are being recruited from the people who currently receive care at the Richmond Family Health Center of the Oregon Health \\& Science University. People who participate in this study will be between 55 and 70 years old, speak English as their preferred language, and have one of several possible diagnoses related to heart health. These could include, for example, hypertension, diabetes, asthma, or obesity.\n\nAdditionally, the investigators are recruiting a small number of health care professionals from the Richmond Family Health Center. Their participation will be similar to but separate from the participation of patients.\n\nAll participants will take two web-based surveys. Some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients.\n\nThe surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients.\n\nData analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-70 years\n* English is preferred language\n* Has one or more chronic cardiovascular-related diagnosis or risk factor\n* Has an appointment with Primary Care provider within 2 weeks of enrollment\n\nExclusion Criteria:\n\n* Inadequate vision or hearing to complete on-line assessment'}, 'identificationModule': {'nctId': 'NCT00983333', 'briefTitle': 'Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Beta Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Web-based Tool for Improving Communication Between Patients and Health Care Professionals', 'orgStudyIdInfo': {'id': 'OHSU00005635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-based communication tool for health care professionals', 'interventionNames': ['Device: Time to Talk CARDIO website']}, {'type': 'EXPERIMENTAL', 'label': 'Web-based communication training tool for patients', 'interventionNames': ['Device: Time to Talk CARDIO website']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care for patient participants'}], 'interventions': [{'name': 'Time to Talk CARDIO website', 'type': 'DEVICE', 'description': 'This interactive web-based training device involves the completion of a brief survey regarding communication experiences between patients and health care professionals. The pattern of responses to the survey generates a personalized set of short instructional videos which demonstrate effective communication skills.', 'armGroupLabels': ['Web-based communication tool for health care professionals', 'Web-based communication training tool for patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97202', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Richmond Family Health Center at Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Clifford A Coleman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Andrew F Pleasant, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Canyon Ranch Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Family Medicine', 'investigatorFullName': 'Cliff Coleman', 'investigatorAffiliation': 'Oregon Health and Science University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-10-14', 'type': 'RELEASE'}, {'date': '2019-11-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cliff Coleman, Assistant Professor of Family Medicine, Oregon Health and Science University'}}}}