Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT06320093
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mental wellbeing of patients with dementia', 'timeFrame': 'baseline, 12 and 14 weeks later', 'description': 'The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks): All of the time = 5; Most of the time = 4; More than half of the time = 3; Less than half of the time = 2 Some of the time = 1; At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.'}, {'measure': 'Change in cognitive status of patients with dementia', 'timeFrame': 'baseline, 12 and 14 weeks later', 'description': 'The cognitive status has been evaluated by the Montreal Cognitive Assessment (MOCA) test. MOCA is an assessment tool used globally to detect early onset of dementia among people of old age. The tool is a one-page 30-point test that the physician can administer to check the memory, language, recall, and other markers of cognitive acuity of a patient. Normal cognition: 26-30 points; Mild Cognitive Impairment: 18-25 points; Moderate Cognitive Impairment: 10-17 points; Severe Cognitive Impairment: under 10 points.'}, {'measure': 'Change in stress of health care providers', 'timeFrame': 'baseline, 12 and 14 weeks later', 'description': 'The Burnout Assessment Tool (BAT) is a self-assessment questionnaire that measures parameters associated with Burnout. All items are expressed as statements with five frequency-based response categories (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). The total burnout score is calculated as a mean of all 23 items, and a high score is indicative of high levels of burnout.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'older people', 'music', 'caregiver'], 'conditions': ['Dementia', 'Older People']}, 'descriptionModule': {'briefSummary': 'The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.', 'detailedDescription': 'The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.\n\nThe study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate dementia\n* no severe hearing and visual impairment or motor problems\n\nExclusion Criteria:\n\n* no formal caregiver\n* no informal caregiver'}, 'identificationModule': {'nctId': 'NCT06320093', 'acronym': 'SOUND', 'briefTitle': 'Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Nazionale di Ricovero e Cura per Anziani'}, 'officialTitle': 'Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia', 'orgStudyIdInfo': {'id': 'INRCA_002_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sound intervention', 'description': 'the SOUND intervention is a new and innovative method of applying musical activities in a circle consisting of elderly people with mild-to-moderate dementia, caregivers, family caregivers and young people.', 'interventionNames': ['Other: SOUND Intervention']}], 'interventions': [{'name': 'SOUND Intervention', 'type': 'OTHER', 'description': 'The intervention involved active (vocal and rhythmic production) and passive (listening to musical pieces) musical activities accompanied by motor coordination exercises. It consisted of 12 meetings (2 per week for 6 weeks) of 45 minutes each.', 'armGroupLabels': ['Sound intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60127', 'city': 'Ancona', 'country': 'Italy', 'facility': 'INRCA Hospital', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Trofa', 'country': 'Portugal', 'facility': 'Sons do Estamine Associacao', 'geoPoint': {'lat': 41.33729, 'lon': -8.5596}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Associatia Habilitas', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Nazionale di Ricovero e Cura per Anziani', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}