Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:59 PM
Study NCT ID:
NCT05658666
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Professional caregiver measures: Changes in quality of communication with the person with dementia', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Professional caregiver measures: changes in quality of relationship with the person with dementia', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Professional caregiver measures: changes in emotional strain', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Loved ones measures: Changes in quality of communication with the person with dementia', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Loved ones measures: Changes in quality of relationship with the person with dementia', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Loved ones measures: Changes in emotional strain', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Loved ones measures: Changes in life satisfaction', 'timeFrame': '5 months', 'description': 'self-developed items'}, {'measure': 'Care team measures: changes in succesful communication with the person with dementia', 'timeFrame': '5 months', 'description': 'succesful communication scheme'}, {'measure': 'Care team measures: changes in attunement with the person with dementia', 'timeFrame': '5 months', 'description': 'relational attunement scheme'}, {'measure': 'Care team measures: Changes in sense of competence of the care team as a whole', 'timeFrame': '5 months', 'description': 'Analysis team learning scale'}], 'primaryOutcomes': [{'measure': 'Changes in sense of competence of the professional caregiver', 'timeFrame': '5 months', 'description': 'Sense of competence in dementia care scale (SCIDS)'}], 'secondaryOutcomes': [{'measure': 'Professional caregiver measures: changes in strain in dementia work', 'timeFrame': '5 months', 'description': 'Strain in dementia care scale (SDC)'}, {'measure': 'Professional caregiver measures: changes in safety in team participation', 'timeFrame': '5 months', 'description': 'Team climate inventory (TCI)'}, {'measure': 'Loved ones measures: changes in sense of competence', 'timeFrame': '5 months', 'description': 'Short sense of competence questionnaire (SSCQ)'}, {'measure': 'Person with dementia: changes in frequency of psychopathology', 'timeFrame': '5 months', 'description': 'Neuropsychiatric inventory nursing home (NPI-NH)'}, {'measure': 'Person with dementia: changes in severity of psychopathology', 'timeFrame': '5 months', 'description': 'Neuropsychiatric inventory nursing home (NPI-NH)'}, {'measure': 'Person with dementia: changes in frequency of agitated behaviors', 'timeFrame': '5 months', 'description': 'Cohen Mansfield Agitation Inventory (CMAI)'}, {'measure': 'Person with dementia: changes in quality of life', 'timeFrame': '5 months', 'description': 'Quality of life - Alzheimer Disease Scale (QOL-AD)'}, {'measure': 'Person with dementia: changes in social well-being', 'timeFrame': '5 months', 'description': 'Revised index for social engagement (RISE)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video Feedback Intervention', 'Dementia', 'Challenging behavior', 'Nursing home'], 'conditions': ['Dementia', 'Nursing Home Resident', 'Challenging Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how, under what circumstances and for whom the video feedback intervention works for (the caregivers of) people with dementia and severe challenging behavior in a nursing home setting.', 'detailedDescription': 'This mixed multiple case study focuses on the evaluation of a video feedback intervention for (the caregivers of) people with dementia and challenging behavior. The video feedback intervention focuses on understanding the person with dementia, increasing the sense of competence in caregivers and improving their communication skills when interacting with the person with dementia. This realist evaluation aims to investigate what outcomes the intervention generates, for whom and in which contexts. Participants will receive care as usual.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Nursing home residents with dementia and severe challenging behavior where video feedback intervention is started by health care professionals as part of usual care.\n* Family caregivers of these nursing home resident\n* Involded professional caregivers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nursing home resident\n* Dementia\n* Severe challenging behavior\n* Video feedback intervention is started by health care professionals as part of usual care\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05658666', 'briefTitle': 'Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Leren Zien Wat Werkt: Video Interventie Ouderenzorg (VIO) Bij cliënten Met Dementie en Ernstig Probleemgedrag in Verpleeghuizen.', 'orgStudyIdInfo': {'id': '111972'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)', 'type': 'BEHAVIORAL', 'description': 'The video feedback trainer assesses the interaction between the person with dementia and the caregiver and acquires agreement from the caregiver on the goals of the intervention. Caregivers are trained during several feedback sessions using personal video footage of interaction between the person with dementia and the caregiver. The feedback focuses on basic interaction and attunement principles, and the team feeling competent. Recording starts with a nondemanding situation, enabling the caregiver to become aware of the principles they already apply and to learn how these principles can be used in more demanding situations. Subsequently, video footage is recorded in 1 to 3 situations, depending on the progress, of increasing difficulty, with about 4 weeks between 2 recordings. After each recording, a 1-hour feedback session is held. The intervention concludes with separate, 30-minute sessions for the formal and informal caregivers evaluating the intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5042 SE', 'city': 'Tilburg', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Inge Hageman, MA', 'role': 'CONTACT', 'email': 'i.hageman@dewever.nl', 'phone': '00316-18 72 75 88'}], 'facility': 'Expertise Centrum VIO de Wever, behandelcentrum de Hazelaar', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}], 'centralContacts': [{'name': 'Debby Gerritsen', 'role': 'CONTACT', 'email': 'debby.gerritsen@radboudumc.nl', 'phone': '+31243618181'}], 'overallOfficials': [{'name': 'Debby Gerritsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}