Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-24 @ 7:56 PM
Study NCT ID:
NCT03832192
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pi@care.coach', 'phone': '8554374569', 'title': 'Principal Investigator', 'phoneExt': '2', 'organization': 'care.coach'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Fall \\& patient sitter data were not recorded at the first site. Secondary sites that were to record such data were stalled by COVID. Post-tests were missing for many patients, due largely to hospital discharges occurring before researchers could conduct post-tests. Incident delirium cases were too few to draw conclusions (far below the rate suggested by literature). The team began to mitigate these data integrity problems, but were not able to rebuild a viable research assistant team post-COVID.'}}, 'adverseEventsModule': {'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': 'The usual definition of a "serious adverse event" includes an inpatient hospitalization, but all subjects are already hospitalized and therefore we are focusing on deaths unless there is a usually-defined serious or non-serious adverse event that is considered attributable to study participation.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incident Delirium Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': "For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \\[CAM\\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without prevalent delirium and have a final CAM screen on record'}, {'type': 'SECONDARY', 'title': 'Delirium Resolution Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': "For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method \\[CAM\\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with prevalent delirium and a final CAM screen on record'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': 'For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with both pre- and post-test data on record'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Delirium Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000'}, {'value': '-5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': 'For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with both pre- and post-test MDAS data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'FG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '149'}]}], 'dropWithdraws': [{'type': 'Participants are disenrolled upon hospital discharge.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '149'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'HELP-protocolized digital avatar with daily nurse student check-in'}, {'id': 'BG001', 'title': 'Control', 'description': 'Usual care with daily nurse student social check-in'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '9', 'groupId': 'BG000'}, {'value': '75', 'spread': '8', 'groupId': 'BG001'}, {'value': '76', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Short Portable Mental Status Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0 to 10 questions incorrectly answered; greater number indicates worse cognitive performance', 'unitOfMeasure': 'number of questions incorrectly answered', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Confusion Assessment Method', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Delirium screening algorithm resulting in either positive of negative presence of delirium', 'unitOfMeasure': 'number of positive screens'}, {'title': 'Memorial Delirium Assessment Scale', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '14.3', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '10 severity items rated 0 to 3 points for a maximum total score of 30 points, with higher scores representing more severe delirium', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-28', 'size': 650608, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-21T20:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-20', 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Delirium Severity', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': 'For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.'}], 'primaryOutcomes': [{'measure': 'Incident Delirium Rate', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': "For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \\[CAM\\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable."}], 'secondaryOutcomes': [{'measure': 'Delirium Resolution Rate', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': "For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method \\[CAM\\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable."}, {'measure': 'Change in Cognitive Function', 'timeFrame': "From beginning to end of each participant's inpatient stay, an average of 4 days", 'description': 'For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient satisfaction', 'HCAHPS', 'loneliness', 'delirium', 'falls', 'HELP', 'hospitals', 'geriatrics', 'elder care'], 'conditions': ['Delirium', 'Fall Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://care.coach', 'label': 'care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination'}]}, 'descriptionModule': {'briefSummary': "Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR) systems. In the present study, the investigators seek to validate the efficacy of the new avatar platform, as measured by reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to gather patient and outcomes data at a scale sufficient to begin developing machine learning algorithms for intelligent, automatic assignment of protocols to maximize patient engagement and clinical efficacy, and for intelligent, automatic screening of delirium to assist care teams in positive identification of delirium. Therefore, the present study comprises a two-year randomized between-groups comparison across multiple hospitals to compare outcomes with the new generation of care.coach avatars as the intervention versus usual care only as the control. Each study group will be geographically distributed across participating research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New York, with additional hospitals to join the study over the course of two years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)\n\nExclusion Criteria:\n\n* aggression or combativeness with intent to harm self or others\n* severe hearing impairment and simultaneous severe vision impairment, despite assistive devices\n* no comprehension of either Spanish or English'}, 'identificationModule': {'nctId': 'NCT03832192', 'acronym': 'AvatarHELP', 'briefTitle': 'Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'care.coach corporation'}, 'officialTitle': 'Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium, Through Psychosocial Support and Protocol-Driven Interventions Based on the Hospital Elder Life Program: a Multi-Site Clinical Study', 'orgStudyIdInfo': {'id': '1R44NR017842-02', 'link': 'https://reporter.nih.gov/quickSearch/1R44NR017842-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'care.coach Avatar', 'interventionNames': ['Behavioral: care.coach Avatar (HELP-Protocolized)']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'care.coach Avatar (HELP-Protocolized)', 'type': 'BEHAVIORAL', 'description': 'care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).', 'armGroupLabels': ['care.coach Avatar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11418', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Jamaica Hospital Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Victor Wang', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'Pace University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Victor Wang', 'investigatorAffiliation': 'care.coach corporation'}}}}