Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 10:13 AM
Study NCT ID:
NCT01115660
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2010-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stroke Education Intervention Trial - Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cbushnel@wakehealth.edu', 'phone': '(336) 716-2357', 'title': 'Dr. Cheryl Bushnell', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Adverse events not collected'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Stroke Education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Patients received standard discharge counseling but no 2-week follow-up call.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Intervention (Ability to Reach Patients at 3 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stroke Education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.'}, {'id': 'OG001', 'title': 'Control', 'description': 'standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Number of patients contacted at 3 months', 'unitOfMeasure': 'number of patients contacted', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who also were available at 3 months for post-intervention follow-up call.'}, {'type': 'SECONDARY', 'title': 'Follow up Appointment With MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stroke Education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.'}, {'id': 'OG001', 'title': 'Control', 'description': 'standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Follow up appointment with primary care provider since stroke', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were contacted at 3 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stroke Education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Patients received standard discharge counseling but no 2-week follow-up call.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrolled patients in 2010 at Wake Forest Baptist Medical Center', 'preAssignmentDetails': 'Patients assigned to intervention arm and control arm, consecutively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stroke Education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Patients received standard discharge counseling but no 2-week follow-up call.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Median Age', 'categories': [{'measurements': [{'value': '61', 'spread': '7', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '70'}, {'value': '59', 'spread': '10', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '67'}, {'value': '61', 'spread': '8', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-11', 'studyFirstSubmitDate': '2010-05-02', 'resultsFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2010-05-02', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-14', 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention (Ability to Reach Patients at 3 Months)', 'timeFrame': '3 months', 'description': 'Number of patients contacted at 3 months'}], 'secondaryOutcomes': [{'measure': 'Follow up Appointment With MD', 'timeFrame': '3 months', 'description': 'Follow up appointment with primary care provider since stroke'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'patient education', 'medication adherence'], 'conditions': ['Ischemic Stroke', 'Intracranial Hemorrhage', 'Transient Ischemic Attack']}, 'referencesModule': {'references': [{'pmid': '22830539', 'type': 'RESULT', 'citation': 'Sides EG, Zimmer LO, Wilson L, Pan W, Olson DM, Peterson ED, Bushnell C. Medication coaching program for patients with minor stroke or TIA: a pilot study. BMC Public Health. 2012 Jul 25;12:549. doi: 10.1186/1471-2458-12-549.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18\n* Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage\n* provide consent to participate\n\nExclusion Criteria:\n\n* discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital\n* homeless\n* non-English speakers\n* patient and proxy unable to participate in telephone conversation'}, 'identificationModule': {'nctId': 'NCT01115660', 'acronym': 'AVAIL II', 'briefTitle': 'Stroke Education Intervention Trial - Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol', 'orgStudyIdInfo': {'id': 'Pro00019690'}, 'secondaryIdInfos': [{'id': '5U18HS016964', 'link': 'https://reporter.nih.gov/quickSearch/5U18HS016964', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stroke education', 'description': 'Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.', 'interventionNames': ['Behavioral: stroke education']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.'}], 'interventions': [{'name': 'stroke education', 'type': 'BEHAVIORAL', 'description': 'call by medication coach 2 weeks after hospital discharge', 'armGroupLabels': ['stroke education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WFUBMC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Eric D Peterson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DCRI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}