Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-14 @ 2:04 AM
Study NCT ID:
NCT03056768
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Health Promotion Intervention Study for Elders
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1080}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline frailty score at 12 months', 'timeFrame': '12 months', 'description': 'Measured by Cardiovascular Health Study(CHS) definition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frail Elderly Syndrome', 'Cognitive Impairment', 'Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '40514302', 'type': 'DERIVED', 'citation': 'Ho MY, Lee WJ, Yen KH, Liang CK, Peng LN, Lin MH, Loh CH, Hsiao FY, Chen LK. Tailoring multidomain intervention programs to reduce cognitive and physical decline in older adults: Examining rural-urban differences in a nationwide cluster-randomized controlled trial. J Prev Alzheimers Dis. 2025 Sep;12(8):100231. doi: 10.1016/j.tjpad.2025.100231. Epub 2025 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.\n\nDesign:\n\nMethods: Randomized controlled trial\n\nSetting:\n\nFive cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)\n\nMeasurements:\n\nPrimary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.', 'detailedDescription': 'Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.\n\nPrimary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prefrail or frail community-dwelling people\n\nExclusion Criteria:\n\n* Institutionalized or ADL dependent\n* Diagnosed dementia\n* Limited life expectancy'}, 'identificationModule': {'nctId': 'NCT03056768', 'acronym': 'THISCE', 'briefTitle': 'Taiwan Health Promotion Intervention Study for Elders', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Taiwan Health Promotion Intervention Study for Elders', 'orgStudyIdInfo': {'id': '14001A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active control', 'description': 'Health promotion provided by local health bureau.', 'interventionNames': ['Behavioral: Active control']}, {'type': 'EXPERIMENTAL', 'label': 'multidomain intervention', 'description': '1-year multidomain health promotion (physical activities, cognitive training, nutritional sessions)', 'interventionNames': ['Behavioral: Multidomain intervention']}], 'interventions': [{'name': 'Multidomain intervention', 'type': 'BEHAVIORAL', 'description': '1-year multidomain health promotion (physical, cognitive, nutritional intervention)', 'armGroupLabels': ['multidomain intervention']}, {'name': 'Active control', 'type': 'BEHAVIORAL', 'description': 'Health promotion activities provided by local health bureau.', 'armGroupLabels': ['active control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liang-Kung Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}