Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:58 AM
Study NCT ID:
NCT07444866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Hybrid factorial - Sequential Multiple Assignment Randomized Trial (SMART), Micro Randomized Trial (MRT) experimental design with a 2x2+1 factorial design (with five arms) randomized clinical trial, 2 stage SMART and three MRTs'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Caregiving', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Caregiving Self-efficacy; 15-item scale. Total score is 100.'}], 'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27'}, {'measure': 'Sleep Quality', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21.'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21.'}, {'measure': 'Physical Health', 'timeFrame': 'Baseline (T0), 32 weeks after baseline assessment (T4)', 'description': 'Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.'}, {'measure': 'Physical Health', 'timeFrame': 'Baseline (T0), 32 weeks after baseline assessment (T4)', 'description': 'Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.'}, {'measure': 'Physical Symptoms', 'timeFrame': 'Baseline (T0), 32 weeks after baseline assessment (T4)', 'description': 'Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210.'}, {'measure': 'Chronic Illness', 'timeFrame': 'Baseline (T0), 32 weeks after baseline assessment (T4)', 'description': 'Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).'}, {'measure': 'Caregiver Burden', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': '12-item Zarit Burden Interview Scale ; each item will be rated from 0=Never to 4=Nearly always. Total scores range from 0 to 48.'}, {'measure': 'Psychological Well-Being', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': '18-item Ryff Psychological Well-Being scale, each item range from 1-strongly agree to 7-strongly disagree. Total score range from 18-126.'}, {'measure': 'Physical and Mental Health', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'SF-12, total score for physical and mental health respectively.'}, {'measure': 'Neuropsychiatric', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Neuropsychiatric Inventory; classified each of the 12 domain into presence of symptom, frequency, severity, and caregiver distress.'}, {'measure': 'Memory and Behaviour Problems', 'timeFrame': 'Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)', 'description': 'Revised Memory and Behavior Problems Checklist; a 24-item checklist from 0=never occurred/not at all to 4=daily/extremely. Higher score indicate more frequent behavioral problems/caregiver distress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hybrid factorial - Sequential Multiple Assignment Randomized Trial, Micro Randomized Trial experimental design', 'machine learning', 'intervention', 'dementia caregiver'], 'conditions': ['Dementia Caregiver']}, 'descriptionModule': {'briefSummary': 'Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 18 above\n* family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community\n* having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment\n* have a smartphone\n* have mild to moderate stress (the 14-item Chinese version Perceived Stress Scale).\n\nExclusion Criteria:\n\n* having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment\n* having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers' participation or adherence (e.g. acute psychosis)"}, 'identificationModule': {'nctId': 'NCT07444866', 'briefTitle': 'Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Education University of Hong Kong'}, 'officialTitle': 'Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study', 'orgStudyIdInfo': {'id': '2023-2024-0387'}, 'secondaryIdInfos': [{'id': '22231921', 'type': 'OTHER_GRANT', 'domain': 'Research Fund Secretariat, Health Bureau'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active control', 'description': 'Active control', 'interventionNames': ['Behavioral: Active Control']}, {'type': 'EXPERIMENTAL', 'label': 'App & Human Coaching + Continue Intervention', 'description': 'First-line of coaching: App + Human Coaching Responder', 'interventionNames': ['Behavioral: Behavioral: Continue']}, {'type': 'EXPERIMENTAL', 'label': 'App & Human Coaching + Increase intensity in human coaching', 'description': 'First-line of coaching: App + Human Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Enhance human coaching']}, {'type': 'EXPERIMENTAL', 'label': 'App & Human Coaching + Booster', 'description': 'First-line of coaching: App + Human Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Booster']}, {'type': 'EXPERIMENTAL', 'label': 'App Coaching + Continue Intervention', 'description': 'First-line of coaching: App Coaching Responder', 'interventionNames': ['Behavioral: Behavioral: Continue']}, {'type': 'EXPERIMENTAL', 'label': 'App Coaching + Increase intensity in human coaching', 'description': 'First-line of coaching: App Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Enhance human coaching']}, {'type': 'EXPERIMENTAL', 'label': 'App Coaching + Booster', 'description': 'First-line of coaching: App Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Booster']}, {'type': 'EXPERIMENTAL', 'label': 'Human Coaching + Continue Intervention', 'description': 'First-line of coaching: Human Coaching Responder', 'interventionNames': ['Behavioral: Behavioral: Continue']}, {'type': 'EXPERIMENTAL', 'label': 'Human Coaching + Increase intensity in human coaching', 'description': 'First-line of coaching: Human Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Enhance human coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Human Coaching + Booster', 'description': 'First-line of coaching: Human Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Booster']}, {'type': 'EXPERIMENTAL', 'label': 'No Coaching + Continue Intervention', 'description': 'First-line of coaching: No Coaching Responder', 'interventionNames': ['Behavioral: Behavioral: Continue']}, {'type': 'EXPERIMENTAL', 'label': 'No Coaching + Increase intensity in human coaching', 'description': 'First-line of coaching: No Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Enhance human coaching']}, {'type': 'EXPERIMENTAL', 'label': 'No Coaching + Booster', 'description': 'First-line of coaching: No Coaching Non-Responder', 'interventionNames': ['Behavioral: Behavioral: Booster']}], 'interventions': [{'name': 'Active Control', 'type': 'BEHAVIORAL', 'description': 'No APP based coaching, no human coaching, no rerandomization, no MRT', 'armGroupLabels': ['Active control']}, {'name': 'Behavioral: Continue', 'type': 'BEHAVIORAL', 'description': 'Continue with existing intervention plan', 'armGroupLabels': ['App & Human Coaching + Continue Intervention', 'App Coaching + Continue Intervention', 'Human Coaching + Continue Intervention', 'No Coaching + Continue Intervention']}, {'name': 'Behavioral: Enhance human coaching', 'type': 'BEHAVIORAL', 'description': 'Increase intensity of human coaching', 'armGroupLabels': ['App & Human Coaching + Increase intensity in human coaching', 'App Coaching + Increase intensity in human coaching', 'Human Coaching + Increase intensity in human coaching', 'No Coaching + Increase intensity in human coaching']}, {'name': 'Behavioral: Booster', 'type': 'BEHAVIORAL', 'description': 'Add a booster session', 'armGroupLabels': ['App & Human Coaching + Booster', 'App Coaching + Booster', 'Human Coaching + Booster', 'No Coaching + Booster']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Kee Lee Chou, PhD', 'role': 'CONTACT', 'email': 'klchou@eduhk.hk', 'phone': '+85229487473'}, {'name': 'Vivien Tang, MSc', 'role': 'CONTACT', 'email': 's1135125@s.eduhk.hk'}], 'facility': 'The Education University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kee Lee Chou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Education University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Education University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, {'name': 'Lingnan University', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Penn State University', 'class': 'OTHER'}, {'name': 'The University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Professor of Social Policy', 'investigatorFullName': 'Chou Kee Lee', 'investigatorAffiliation': 'Education University of Hong Kong'}}}}