Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06984458
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-22
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Function Assessed by SPMSQ', 'timeFrame': 'Participants will complete the SPMSQ at baseline, post-intervention (week 8), and follow-up (week 20).'}, {'measure': 'Change in Depression Symptoms Assessed by GDS-15', 'timeFrame': 'The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).'}, {'measure': 'Change in Social Engagement and Activities Assessed by SEAQ', 'timeFrame': 'The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).'}, {'measure': 'Change in Psychological Well-being Assessed by WHO-5', 'timeFrame': 'The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).'}, {'measure': 'Change in loneliness Assessed by UCLA Loneliness Scale', 'timeFrame': 'The instrument will be administered at baseline, post-intervention (week 8), and follow-up (week 20).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robot-delivery intervention, Dementia prevention, Dementia, Community elderly'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Dementia', 'Cognitive Decline', 'Psychological Well-being', 'Aging and Cognitive Health']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to intervene in the cognitive functions of the community elderly through the "Robot Dementia Prevention Course" training. It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline.\n\nThis study is a quasi-experimental design. It adopts pre-test and post-test methods for the experimental group and the control group. Before the intervention of the "Robotic Dementia Prevention Course", the community elderly were given a pre-test. After receiving an 8-week course (two months), the first post-test will be conducted, and three months later, the second post-test (post-post-test) will be conducted to analyze the delay effect. The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months), classes were taken in the elderly\'s original care center or long-term care base; the control group did not receive any course intervention. Statistical methods were analyzed using SPSS version 23.0, and descriptive statistics, paired t tests, generalized estimating equations, etc. were used to test the changes before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years or older, Able to communicate in Mandarin or Taiwanese, Able to provide informed consent or have a legal guardian provide consent\n\nExclusion Criteria:\n\n* Diagnosis of severe dementia or advanced neurodegenerative disease, Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), Unconsciousness or inability to stay awake or focused for the session duration, Inability to comply with study protocol or scheduled sessions'}, 'identificationModule': {'nctId': 'NCT06984458', 'briefTitle': 'Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'Exploring the Impact of Dementia Prevention Programs Using Robots as Intervention Tools on Community Elderly', 'orgStudyIdInfo': {'id': '202503HM004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dementia Prevention Programs Using Robots as Intervention Tools', 'description': 'The experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class. They are held once a week, with a total of 8 weeks of courses (duration two months).', 'interventionNames': ['Behavioral: Robot Dementia Prevention Course']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group did not receive any course intervention. The community elderly were given a pre-test. After 8 weeks (two months), the f post-test will be conducted.'}], 'interventions': [{'name': 'Robot Dementia Prevention Course', 'type': 'BEHAVIORAL', 'description': 'It is expected that through the eight-week course design activities, the cognitive functions, social activities, emotional management (such as alleviating depression), well-being, reduce loneliness and can be achieved, thereby preventing or delaying cognitive decline.\n\nThe experimental group conducted a two-month "Robot Dementia Prevention Course" intervention. The research subjects were 40 people. Each group of 5 people was assigned a Kebbi robot. The course intervention was divided into 8 groups. The Kebbi robot mainly taught and communicated with the elderly interactively. There is a well-trained teaching assistant in the class to enhance the learning effect of the elderly. The two classes per week are about 2 hours long, with 50 minutes of course knowledge introduction, 10 minutes of rest, 50 minutes of interaction with Kebbi Artificial Intelligence-based board games, and 10 minutes of prize-based quizzes after class.', 'armGroupLabels': ['Dementia Prevention Programs Using Robots as Intervention Tools']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10610', 'city': 'Taipei', 'state': 'Taipei City', 'country': 'Taiwan', 'facility': 'National Taiwan Normal University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Jong-Long Guo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}