Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-07-02 @ 3:20 AM
Study NCT ID:
NCT03612167
Status:
SUSPENDED
Last Update Posted:
2020-09-10
First Post:
2018-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A quasi-experimental design with nonequivalent control was adopted in a senior center. Experimental variable was a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Participants were allocated into intervention group (cognitive intervention group) and control group (nutrition education group). The group assignment depended on what group they signed up for participate.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'whyStopped': 'no funding', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2018-07-22', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mini-Mental State Examination', 'timeFrame': '3 month', 'description': 'cognition'}, {'measure': 'the Trail Making Test', 'timeFrame': '3 month', 'description': 'attention'}, {'measure': 'the Color Trail Test', 'timeFrame': '3 month', 'description': 'attention'}, {'measure': 'Rivermead Behavioral Memory Test', 'timeFrame': '3 month', 'description': 'memory'}, {'measure': 'the Contextual Memory Test', 'timeFrame': '3 month', 'description': 'memory'}, {'measure': 'the Digit Span test', 'timeFrame': '3 month', 'description': 'memory'}], 'secondaryOutcomes': [{'measure': 'Cognitive Failure Questionnaire and the', 'timeFrame': '3 month', 'description': 'perceived cognitive failures'}, {'measure': 'Everyday Memory Questionnaire', 'timeFrame': '3 month', 'description': 'perceived memory problems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subjective Cognitive Complaints']}, 'descriptionModule': {'briefSummary': 'Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.\n2. Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.\n3. Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.\n\nExclusion Criteria:\n\n1. A confirmed diagnosis of dementia\n2. With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.\n3. With Mini Mental Status Exam \\<=24 (education status beyond primary school); or \\<=16 (No education)\n4. With less than 10-session participation rate out of 12."}, 'identificationModule': {'nctId': 'NCT03612167', 'briefTitle': 'Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': 'Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults', 'orgStudyIdInfo': {'id': '102-2717B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multi-modal cognitive intervention', 'description': 'a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.', 'interventionNames': ['Behavioral: cognitive intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nutritional group', 'description': 'A quasi-experimental design with nonequivalent control was adopted in a senior center. The intervention for control group was a 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).', 'interventionNames': ['Behavioral: nutritional group']}], 'interventions': [{'name': 'cognitive intervention', 'type': 'BEHAVIORAL', 'description': 'a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.', 'armGroupLabels': ['multi-modal cognitive intervention']}, {'name': 'nutritional group', 'type': 'BEHAVIORAL', 'description': '12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).', 'armGroupLabels': ['nutritional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng-Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'On-going research. Individual data will only share within the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ling-Hui Chang', 'investigatorAffiliation': 'National Cheng Kung University'}}}}