Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-05 @ 6:14 PM
Study NCT ID:
NCT06488157
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vep9012@med.cornell.edu', 'phone': '212-746-7000', 'title': 'Dr. Veerawat Phongtankuel', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Only caregivers of patients with ADRD, not their care recipients, were assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'This measure represents the recruitment rate for all participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Recruitment (7 months)', 'description': 'Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.', 'unitOfMeasure': 'percentage of all eligible participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who we reached out to and were eligible for our study, including those who refused to participate or were unreachable over multiple attempts, were included in the number of participants analyzed for this measure.'}, {'type': 'PRIMARY', 'title': 'Feasibility, as Measured by the Percentage of Tele-visits Conducted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Tele-visits', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of the intervention or at 12 weeks, whichever is earlier', 'description': 'Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient.', 'unitOfMeasure': 'percentage of tele-visits conducted', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tele-visits', 'denomUnitsSelected': 'Tele-visits'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD.', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was not collected because, after completing the first phase of the study, we found it was not relevant to the participants in the clinical trial.'}, {'type': 'SECONDARY', 'title': 'Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '3.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 week', 'description': 'Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed at each time point varied because:\n\nA caregiver was ineligible to participate due to their care recipient passing away.\n\nA caregiver missed the tele-visit session on that particular week.'}, {'type': 'SECONDARY', 'title': 'Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '4.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '4.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '4.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed at each time point varied because:\n\nA caregiver was ineligible to participate due to their care recipient passing away.\n\nA caregiver missed the tele-visit session on that particular week.'}, {'type': 'SECONDARY', 'title': 'Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '6.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '7.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '5.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '6.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '7.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '6.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '7.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed at each time point varied because:\n\nA caregiver was ineligible to participate due to their care recipient passing away.\n\nA caregiver missed the tele-visit session on that particular week.'}, {'type': 'SECONDARY', 'title': "Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '4.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': "Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed at each time point varied because:\n\nA caregiver was ineligible to participate due to their care recipient passing away.\n\nA caregiver missed the tele-visit session on that particular week.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.\n\nI-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '12.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Education Completed', 'classes': [{'categories': [{'title': 'Some high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'High School or GED', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Some College', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'College degree', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Post-graduate but no degree', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Graduate Degree', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Household Income Range', 'classes': [{'categories': [{'title': '$25,000 or less', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '$25,001 to $50,000', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '$50,001 to $75,000', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '$75,001 or greater', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship to Patient', 'classes': [{'categories': [{'title': 'Spouse/partner', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Child', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Relative', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Friend', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Paid Caregiver', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-26', 'size': 398831, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-13T10:51', 'hasProtocol': True}, {'date': '2023-06-05', 'size': 257058, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T04:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2024-06-28', 'resultsFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study', 'timeFrame': 'Recruitment (7 months)', 'description': 'Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.'}, {'measure': 'Feasibility, as Measured by the Percentage of Tele-visits Conducted', 'timeFrame': 'At the end of the intervention or at 12 weeks, whichever is earlier', 'description': 'Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient.'}], 'secondaryOutcomes': [{'measure': 'Change in Behavioral and Psychosocial Symptoms of Dementia (BPSD) in the Patient, as Measured by the Neuropsychiatric Inventory Questionnaire', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD.'}, {'measure': 'Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 week', 'description': 'Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.'}, {'measure': 'Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.'}, {'measure': 'Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version', 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': 'Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.'}, {'measure': "Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment", 'timeFrame': 'Baseline, 2, 4, 6, 8, 10, 12 weeks', 'description': "Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver Burden']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old and \\< 100 years\n* English speaking\n* Providing care to an ADRD patient who is age ≥ 65 years old and \\< 105 years who is a stage 7a-f on the Functional Assessment Staging Tool (FAST) scale\n\nExclusion Criteria:\n\n* Non-English speaking\n* \\<18 years old or \\>100 years old'}, 'identificationModule': {'nctId': 'NCT06488157', 'briefTitle': 'Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD', 'orgStudyIdInfo': {'id': '23-01025643'}, 'secondaryIdInfos': [{'id': 'K76AG059997-04S1', 'link': 'https://reporter.nih.gov/quickSearch/K76AG059997-04S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (I-HoME)', 'description': 'Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.', 'interventionNames': ['Other: I-HoME']}], 'interventions': [{'name': 'I-HoME', 'type': 'OTHER', 'description': 'Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs', 'armGroupLabels': ['Intervention (I-HoME)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Veerawat Phongtankuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}