Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-03 @ 12:46 AM
Study NCT ID:
NCT02207803
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pperrin@vcu.edu', 'phone': '8048273894', 'title': 'Dr. Paul Perrin', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4-month data collection window', 'eventGroups': [{'id': 'EG000', 'title': 'Transition Assistance Program', 'description': 'Group receiving the 5-session behavioral treatment from a clinician', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Group receiving the standard of care at the rehabilitation facility', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Zarit Burden Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transition Assistance Program', 'description': 'Group receiving the 5-session behavioral treatment from a clinician'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group receiving the standard of care at the rehabilitation facility'}], 'classes': [{'categories': [{'measurements': [{'value': '23.41', 'spread': '16.50', 'groupId': 'OG000'}, {'value': '26.48', 'spread': '19.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months post-hospital discharge', 'description': '22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are from caregivers only, hence not the full sample.'}, {'type': 'SECONDARY', 'title': 'Exemplary Care Scale-Provide Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transition Assistance Program', 'description': 'Group receiving the 5-session behavioral treatment from a clinician'}, {'id': 'OG001', 'title': 'Control', 'description': 'Group receiving the standard of care at the rehabilitation facility'}], 'classes': [{'categories': [{'measurements': [{'value': '14.23', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '14.07', 'spread': '2.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months post-hospital discharge', 'description': "4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is patient-report only at post-test, hence it does not use the full sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transition Assistance Program', 'description': 'Group receiving the 5-session behavioral treatment from a clinician'}, {'id': 'FG001', 'title': 'Control', 'description': 'Group receiving the standard of care at the rehabilitation facility'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transition Assistance Program', 'description': 'Group receiving the 5-session behavioral treatment from a clinician'}, {'id': 'BG001', 'title': 'Control', 'description': 'Group receiving the standard of care at the rehabilitation facility'}, {'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': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '14', 'groupId': 'BG000'}, {'value': '39', 'spread': '13', 'groupId': 'BG001'}, {'value': '38', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'Colombia', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-06', 'size': 129662, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-08-15T08:42', 'hasProtocol': False}, {'date': '2014-05-06', 'size': 232423, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-21T16:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2014-07-31', 'resultsFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-19', 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zarit Burden Interview', 'timeFrame': '2 months post-hospital discharge', 'description': '22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.'}], 'secondaryOutcomes': [{'measure': 'Exemplary Care Scale-Provide Subscale', 'timeFrame': '2 months post-hospital discharge', 'description': "4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brain Injuries', 'Caregivers', 'Intervention Studies', 'Latin America'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'TBI Patient Inclusion Criteria:\n\n* Will be discharged home and not to a nursing home\n* Give permission for their caregiver to participate\n* Sign an informed consent\n* Have the ability to communicate over the phone for data collection\n* Are between 18-60 years of age\n\nCaregiver Inclusion Criteria\n\n* Have a telephone in the home or cellular phone and are able to talk on the phone\n* Sign an informed consent\n* Score at least a 13 on a health literacy screening tool\n* Are between 18-85 years of age'}, 'identificationModule': {'nctId': 'NCT02207803', 'briefTitle': 'A Culturally Sensitive Intervention for TBI Caregivers in Latin America', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Culturally Sensitive Intervention for TBI Caregivers in Latin America', 'orgStudyIdInfo': {'id': 'HM20001660'}, 'secondaryIdInfos': [{'id': 'R21TW009746', 'link': 'https://reporter.nih.gov/quickSearch/R21TW009746', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Experimental Transition Assistance Program', 'interventionNames': ['Behavioral: Transition Assistance Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control'}], 'interventions': [{'name': 'Transition Assistance Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Pontificia Universidad Javeriana Cali', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '0000', 'city': 'Neiva', 'country': 'Colombia', 'facility': 'Universidad Sur Colombiana', 'geoPoint': {'lat': 2.93001, 'lon': -75.27973}}, {'zip': '14269', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'National Institute of Neurology and Neurosurgery', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Paul B. Perrin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}