Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT05301868
Status:
UNKNOWN
Last Update Posted:
2022-04-13
First Post:
2022-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cognition', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Repeatable Battery for the Assessment of Neuropsychological Status'}], 'secondaryOutcomes': [{'measure': 'Change of global cognition', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.'}, {'measure': 'Change of function', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.'}, {'measure': 'Change of subjective memory', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.'}, {'measure': 'Change of depression', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.'}, {'measure': "Quality of life assessed by the Quality of life-Alzheimer's disease", 'timeFrame': 'Change from Baseline at 24 weeks', 'description': "Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance."}, {'measure': 'Change of activities of daily living', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.'}, {'measure': 'Change of nutritional behavior', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.'}, {'measure': 'Change of nutrition', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.'}, {'measure': 'Change of motor function', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.'}, {'measure': 'Sleep quality assessed by the Pittsburgh Sleep Quality Index', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.'}, {'measure': 'Change of motivation', 'timeFrame': 'Change from Baseline at 24 weeks. Higher scores indicate better performance.', 'description': 'Self Determination Index (SDI) (range -66\\~66). Higher scores of SDI indicate better performance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform in mild cognitive impairment.', 'detailedDescription': 'The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the Mediterranean-DASH Intervention for Neurodegenerative Delay diet (MIND) diet. They will be educated about vascular risk factor management every 2 weeks. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities. All intervention will be administered via tablet personal computer (PC) application at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment".\n* Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.\n* Having a reliable informant who could provide investigators with the requested information\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Major psychiatric illness such as major depressive disorders\n* Dementia\n* Other neurodegenerative disease (e.g., Parkinson\'s disease)\n* Malignancy within 5 years\n* Cardiac stent or revascularization within 1 year\n* Serious or unstable symptomatic cardiovascular disease\n* Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease\n* Severe loss of vision, hearing, or communicative disability\n* Any conditions preventing cooperation as judged by the study physician\n* Significant laboratory abnormality that may result in cognitive impairment\n* Illiteracy\n* Unable to participate in exercise program safely\n* Coincident participation in any other intervention trial'}, 'identificationModule': {'nctId': 'NCT05301868', 'acronym': 'EXTENDED', 'briefTitle': 'Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'A Multicenter Clinical Study to Evaluate the Efficacy and Feasibility of a 24-week Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': '2022-02-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidomain intervention', 'description': 'The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training; (3) physical exercise; (4) nutritional guidance; and (5) motivational training via none-face-to-face tablet PC application (app).', 'interventionNames': ['Behavioral: Multidomain intervention']}], 'interventions': [{'name': 'Multidomain intervention', 'type': 'BEHAVIORAL', 'otherNames': ['multidomain cognitive intervention'], 'description': 'For 24 weeks, participants will receive cognitive training twice a week, exercise 3 times a week, nutrition education 12 times, and education about vascular risk factor management every 2 weeks using the tablet PC application.', 'armGroupLabels': ['Multidomain intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo Hyun Cho, MD', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '22332', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seong Hye Choi, MD', 'role': 'CONTACT'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jee Hyang Jeong, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Ewha Womans Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'So Young Moon, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Seong Hye Choi, MD, PhD', 'role': 'CONTACT', 'email': 'seonghye@inha.ac.kr', 'phone': '82 32 890 3659'}, {'name': 'Jee Hyang Jeong, MD, PhD', 'role': 'CONTACT', 'email': 'jjeong@ewha.ac.kr'}], 'overallOfficials': [{'name': 'Seong Hye Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available for 2 years since March 2024.', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study will be available from the principal investigator upon reasonable request.', 'accessCriteria': 'Reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seong Hye Choi, MD', 'investigatorAffiliation': 'Inha University Hospital'}}}}