Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT05481320
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phone Intervention for Family Dementia Caregivers in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lwhinton@ucdavis.edu', 'phone': '9167343485', 'title': 'Ladson Hinton, MD', 'organization': 'UC Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each participant, adverse events were collected for the duration of participation in the study (i.e., up to 3 months)', 'eventGroups': [{'id': 'EG000', 'title': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Control', 'description': 'A single phone session focused on education about the nature of dementia.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Zarit Burden Interview-6 (ZBI-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.'}, {'id': 'OG001', 'title': 'Enhanced Control', 'description': 'A single phone session focused on education about the nature of dementia.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '8.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analytic sample included participants who completed 3-month assessment.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-4 (PHQ-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.'}, {'id': 'OG001', 'title': 'Enhanced Control', 'description': 'A single phone session focused on education about the nature of dementia.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analytic sample included participants who completed 3-month assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.'}, {'id': 'FG001', 'title': 'Enhanced Control', 'description': 'A single phone session focused on education about the nature of dementia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '30'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '25'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Care recipent passed away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Out-of-window assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No longer a primary caregiver', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'cluster'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.'}, {'id': 'BG001', 'title': 'Enhanced Control', 'description': 'A single phone session focused on education about the nature of dementia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', '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': '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': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Vietnam', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Zarit Burden Interview-6 (ZBI-6)', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measures caregiver burden related to caregiving before intervention. Range is 0-24. A higher score indicates a higher burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Health Questionnaire-4 (PHQ-4)', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measures caregiver psychological distress before intervenion (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a great level of psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-16', 'size': 312290, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-21T15:04', 'hasProtocol': True}, {'date': '2022-10-17', 'size': 140350, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-21T15:04', 'hasProtocol': False}, {'date': '2022-07-14', 'size': 142519, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-21T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The active treatment is a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2022-07-28', 'resultsFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-18', 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zarit Burden Interview-6 (ZBI-6)', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-4 (PHQ-4)', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'family caregiving', 'phone intervention', 'non-pharmacological intervention', 'dementia caregivers'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': "This is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving intervention, to support family caregivers of persons living with dementia in Vietnam.", 'detailedDescription': "The objective of this study is to conduct a cluster randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), a psychosocial culturally adapted Alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. The pilot cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate.\n* In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4).\n* All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 3 participants and a maximum of 15 participants.\n\nExclusion Criteria:\n\n* Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing)\n* Caregivers don't have access to phone\n* Individuals who are not yet adults (i.e., infants, children, teenagers)\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT05481320', 'briefTitle': 'A Phone Intervention for Family Dementia Caregivers in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'A Phone Intervention for Family Dementia Caregivers in Vietnam', 'orgStudyIdInfo': {'id': '1937464'}, 'secondaryIdInfos': [{'id': 'R01AG064688', 'link': 'https://reporter.nih.gov/quickSearch/R01AG064688', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REACH VN Phone Intervention', 'description': 'A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers.', 'interventionNames': ['Behavioral: REACH VN Phone Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Enhanced control', 'description': 'A single phone session focused on education about the nature of dementia.', 'interventionNames': ['Behavioral: Enhanced Control']}], 'interventions': [{'name': 'REACH VN Phone Intervention', 'type': 'BEHAVIORAL', 'description': '4-6 intervention sessions delivered via phone over the course of 1-3 months.', 'armGroupLabels': ['REACH VN Phone Intervention']}, {'name': 'Enhanced Control', 'type': 'BEHAVIORAL', 'description': 'A single phone session providing education about dementia.', 'armGroupLabels': ['Enhanced control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vietnam National Geriatric Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'National Geriatric Hospital', 'class': 'OTHER_GOV'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}