Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-30 @ 11:32 AM
Study NCT ID:
NCT01816061
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D012917', 'term': 'Social Adjustment'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joel.scholten@va.gov', 'phone': '2027458000', 'title': 'Dr.Joel Scholten', 'phoneExt': '55099', 'organization': 'DCVAMC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'description': 'Veterans were contacted per protocol, both those in the study arm and the control arm. In addition study participants continued to receive clinical care from the Polytrauma team at the Washington DC VA Medical Center where they were routinely assessed for their reported clinical concerns.\n\nduring the study period no adverse events were reported', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Experimental', 'description': 'The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.\n\nExperimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 1: Control', 'description': 'Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.\n\nControl\n\nControl - COMPASS: Increased hours of patient-provider interactions Group.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Community Reintegration for Injured Service Members at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.\n\nExperimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.'}, {'id': 'OG001', 'title': 'Arm 1: Control', 'description': 'Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.\n\nControl\n\nControl - COMPASS: Increased hours of patient-provider interactions Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.22', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '37.79', 'spread': '6.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Frontal Systems Behavior Scale at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.\n\nExperimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.'}, {'id': 'OG001', 'title': 'Arm 1: Control', 'description': 'Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.\n\nControl\n\nControl - COMPASS: Increased hours of patient-provider interactions Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '13.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Experimental', 'description': 'The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.\n\nExperimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.'}, {'id': 'FG001', 'title': 'Arm 1: Control', 'description': 'Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.\n\nControl\n\nControl - COMPASS: Increased hours of patient-provider interactions Group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental - COMPASS', 'description': 'The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research.\n\nExperimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.'}, {'id': 'BG001', 'title': 'Control - COMMPASS', 'description': 'Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.\n\nControl\n\nControl - COMPASS: Increased hours of patient-provider interactions Group.'}, {'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': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '39.7', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', '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': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-07', 'size': 1626726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-31T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2013-03-19', 'resultsFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-31', 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Community Reintegration for Injured Service Members at 2 Months', 'timeFrame': 'Baseline and 2 months', 'description': 'Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)'}, {'measure': 'Change From Baseline in Frontal Systems Behavior Scale at 2 Months', 'timeFrame': 'Baseline and 2 months', 'description': 'Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Veterans Health', 'Social Adjustment', 'Traumatic Brain Injury (TBI)', 'Post-Traumatic Stress Disorder (PTSD)', 'Independent Living', 'Goals', 'Education'], 'conditions': ['Traumatic Brain Injury', 'Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '26664736', 'type': 'RESULT', 'citation': 'Libin AV, Scholten J, Schladen MM, Danford E, Shara N, Penk W, Grafman J, Resnik L, Bruner D, Cichon S, Philmon M, Tsai B, Blackman M, Dromerick A. Executive functioning in TBI from rehabilitation to social reintegration: COMPASS (goal,) a randomized controlled trial (grant: 1I01RX000637-01A3 by the VA ORD RR&D, 2013-2016). Mil Med Res. 2015 Nov 30;2:32. doi: 10.1186/s40779-015-0061-2. eCollection 2015.'}, {'pmid': '28206800', 'type': 'RESULT', 'citation': 'Libin AV, Schladen MM, Danford E, Cichon S, Bruner D, Scholten J, Llorente M, Zapata S, Dromerick AW, Blackman MR, Magruder KM. Perspectives of veterans with mild traumatic brain injury on community reintegration: Making sense of unplanned separation from service. Am J Orthopsychiatry. 2017;87(2):129-138. doi: 10.1037/ort0000253.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28206800', 'label': 'Libin, Scholten et al. Perspectives of veterans with mild traumatic brain injury on community reintegration'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/26664736', 'label': 'Libin, Scholten et al. Executive functioning in TBI from rehabilitation to social reintegration'}]}, 'descriptionModule': {'briefSummary': 'Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD', 'detailedDescription': "The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research. The COMPASSgoal intervention will be developed and implemented to meet these needs. COMPASSgoal will integrate principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom impact.3F One important mechanism of action of this program appears to be its positive effect on self-efficacy, or confidence in one's ability to attain goals and solve problems.4F\n\nThe study goal is to gather data on the efficacy of a novel approach to psychosocial rehabilitation for Veterans with executive function impairment due to traumatic brain injury (TBI), and to explore over time, through relevant measures, Veteran responsiveness to intervention. Veterans with mild TBI will be randomized into two groups: the COMPASS (Community Participation through Self-Efficacy Skills Development) goal-management intervention group and the supported discharge group.\n\n110 participants with residual deficits in executive function due to TBI will be recruited at a minimum of 3 months post-injury from the TBI program at the DC VAMC over the three-year period of the study. The operational definition of executive dysfunction/ inclusion into the study is based on both clinical diagnosis by a study physician and a standardized executive dysfunction measure, the Frontal Systems Rating Scale (FrSBe score), such that a total score or any of the 3 subscale scores \\< 1 SD compared to the normative score would indicate executive dysfunction sufficient to include in the study. The treatment phase for the Veterans enrolled in the intervention group will continue for two consecutive months (8 weekly sessions)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TBI of at least mild severity using criteria related to disturbance of consciousness (VHA TBI Comprehensive Evaluation screening tool).\n* Obtained informed consent.\n* Males or females of working age, between the ages of 18 and 55.\n* Medically stable with physician approval to participate\n* Ability to comprehend and communicate in English at a 6th grade level\n* Executive dysfunction as identified by Frontal Systems Rating Scale (FrSBe) and/or other study assessments\n\nExclusion Criteria:\n\n* Unable to provide informed consent and no proxy available.\n* Severe impairment of language or day- to-day memory that would preclude participation in a verbally-based therapy.\n* Life expectancy of less than 36 months.\n* Severe multiple trauma (as judged by the attending physicians and/or investigators that is too severe to participate in this study) such as:\n\n * severe burns\n * serious organ damage\n * amputations\n * multiple fractures\n* History of substance abuse severe enough to cause neurologic damage, pre-morbid history of neurologic disease (e.g., stroke).\n* Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness as determined by medical history.'}, 'identificationModule': {'nctId': 'NCT01816061', 'acronym': 'COMPASS', 'briefTitle': 'Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS', 'orgStudyIdInfo': {'id': 'D0637-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental - COMPASS', 'description': 'Goal-setting sessions', 'interventionNames': ['Behavioral: Experimental - COMPASS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - COMPASS', 'description': 'Informative phone calls', 'interventionNames': ['Behavioral: Control - COMPASS']}], 'interventions': [{'name': 'Experimental - COMPASS', 'type': 'BEHAVIORAL', 'description': 'Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.', 'armGroupLabels': ['Experimental - COMPASS']}, {'name': 'Control - COMPASS', 'type': 'BEHAVIORAL', 'otherNames': ['Supported discharge group'], 'description': 'Increased hours of patient-provider interactions Group.', 'armGroupLabels': ['Control - COMPASS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington DC VA Medical Center, Washington, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Joel Scholten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DCVAMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}