Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT07239869
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in physical activity', 'timeFrame': 'Pre-intervention and immediately post-intervention', 'description': 'Physical activity will be measured with the Chinese version of the International Physical Activity Questionnaire short version (IPAQ-C, short). The IPAQ-C is a 9-item instrument with good reliability and validity. Objective mesures will include number of steps, movement distance, sedentary minutes, inactive minutes collected with an activity tracker.'}], 'secondaryOutcomes': [{'measure': 'Changes in self-efficacy in physical activity', 'timeFrame': 'Pre-intervention and immediately post-intervention', 'description': 'Self-efficacy in physical activity will be measured with a Likert 6-point scale covering three different types of self-efficacy. This instrument demonstrated satisfactory internal consistency. Higher scores indicate higher self-efficacy in physical activity.'}, {'measure': 'Changes in quality of life', 'timeFrame': 'Pre-intervention and immediately post-intervention', 'description': 'Dyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life'}, {'measure': 'Changes in neuropsychiatric symptoms of people with dementia', 'timeFrame': 'Pre-intervention and immediately post-intervention', 'description': "People with dementia's neuropsychiatric symptoms will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia. The Chinese version was reliable. Higher scores indicate worse symptoms"}, {'measure': 'Changes in psychological well-being', 'timeFrame': 'Pre-intervention and immediately post-intervention', 'description': "Dyads' psychological well-being will be measured with the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 includes 3 subscales (stress, anxiety, and depression), and has demonstrated good reliability among the Chinese population. Higher scores indicate poorer psychological wellbeing and more psychological distress."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Caregiver', 'Physical Activity', 'Psychological Well Being']}, 'descriptionModule': {'briefSummary': 'To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.', 'detailedDescription': 'This is a two-arm pilot randomized controlled trial evaluating the feasiblity and preliminary efficacy of the robot-assisted tailored activity programme on improving the physical inactivity of people with dementia and their caregivers. Sixty dyads will be rectuited. Participants in the intervention group will receive a 12-week tailored activity programme, while those in the control group will receive usal community care services. Outcomes including feasibility of the tailored acitivity programme, physical activity levels, self-efficacy in physical activity, dyadic quality of life, neuropsychiatric somptoms, and psychological wellbeing will be measured at baseline and immediately post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for people with dementia:\n\n* mild to moderate stage dementia at a standardized mini-mental state examination score (MMSE) higher than 10;\n* be able to walk independently;\n* being physically inactive (categorized as "low/inactive" by the International Physical Activity Questionnaire);\n* free from other medical/functional conditions that would limit physical activity.\n\nExclusion Criteria for people with dementia:\n\n* high risk of falling (Berg Balance Scale \\<45);\n* not be suitable for doing physical activity as recommended by the primary care physician;\n* currently involved in another interventional study involving physical exercise;\n* had acute hospitalization \\>3 times in the past year.\n\nInclusion Criteria for caregivers:\n\n* primary informal caregivers who reside with the of the person with dementia;\n* have provided care for more than six months;\n* have no intention to send the care recipient to nursing homes in the next six months;\n* being physically inactive;\n* use a smartphone.\n\nExclusion Criteria for caregivers:\n\n* caregivers with unstable physical or mental conditions;\n* cannot communicate logically;\n* not suitable for doing physical activity as recommended by a primary care physician.'}, 'identificationModule': {'nctId': 'NCT07239869', 'briefTitle': 'A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers', 'orgStudyIdInfo': {'id': 'P0044775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Tweleve weeks of robot-assisted tailored activity programme', 'interventionNames': ['Other: Intervention']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Usual care provided by community centers', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'OTHER', 'description': '12 weeks of robot assisted tailored activity programme', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Usual care provided by community centers', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shanshan Wang', 'role': 'CONTACT', 'email': 'shan-shan.wang@polyu.edu.hk', 'phone': '+85227664696'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}