Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 7:03 PM
Study NCT ID:
NCT05622734
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ozasl@uw.edu', 'phone': '2068493301', 'title': 'Oleg Zaslavsky', 'organization': 'University of Washington School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to one month after the end of the intervention', 'eventGroups': [{'id': 'EG000', 'title': 'VOCALE LBD+', 'description': 'VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VOCALE LBD+', 'description': 'VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '0.29'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; 4 weeks', 'description': "Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VOCALE LBD+', 'description': 'VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'VOCALE LBD+', 'description': 'VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spouse/partner', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-27', 'size': 22143, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-27T13:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2022-11-09', 'resultsFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-27', 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks', 'timeFrame': 'Baseline; 4 weeks', 'description': "Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver Burden', 'Lewy Body Disease', 'Stress', 'Skill, Coping']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial efficacy of the VOCALE LBD+ intervention in caregivers of persons living with Lewy Body Dementia. The main question\\[s\\] it aims to answer are:\n\n* What is the extent to which the VOCALE LBD+ intervention affects caregiving mastery scores at the end of the eight-week intervention\n* What is the extent to which a change in caregiving mastery scores is retained four weeks after the end of the VOCALE LBD+ intervention\n\nParticipants will be asked to participate in a fully online asynchronous VOCALE LBD+ intervention that involves a moderated web-based discussion platform, peer-to-peer support, didactic training, and problem-solving skill enactment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informal and/or lay caregiver of a patient with LBD\n* Can read, write, and speak English\n* Has access to a device that can be used for videoconferencing and/or phone calls\n* 18 years or older\n\nExclusion Criteria:\n\n* Not an informal and/or lay caregiver\n* Cannot read and write in English\n* No access to a device that can be used for videoconferencing and/or phone calls Younger than 18 years old'}, 'identificationModule': {'nctId': 'NCT05622734', 'briefTitle': 'VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia', 'orgStudyIdInfo': {'id': 'STUDY00015485'}, 'secondaryIdInfos': [{'id': 'P30AG064200', 'link': 'https://reporter.nih.gov/quickSearch/P30AG064200', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOCALE LBD+', 'interventionNames': ['Behavioral: VOCALE LBD+']}], 'interventions': [{'name': 'VOCALE LBD+', 'type': 'BEHAVIORAL', 'description': 'Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.', 'armGroupLabels': ['VOCALE LBD+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Nursing', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Oleg Zaslavsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emory University', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Nursing', 'investigatorFullName': 'Oleg Zaslavsky', 'investigatorAffiliation': 'University of Washington'}}}}