Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-07 @ 8:28 AM
Study NCT ID:
NCT02160093
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation instrument of mental frailty for older adults', 'timeFrame': 'Up to 2 years', 'description': 'The psychological adaptation to aging is a dynamic process. The dynamic process and the Selection-Optimization-Compensation process will have their effect on the actual coping actions in everyday life. The instruments will be set up to evaluate the aging psychology process'}], 'secondaryOutcomes': [{'measure': 'Compare the well chronic disease control and inappropriate condition on the dynamic frail transitions in ambulatory geriatric outpatients', 'timeFrame': 'up to 4 years', 'description': 'The records of chronic disease control status of the same ambulatory geriatric outpatients from previous study, "Clinical evaluation, biomarkers and metabolomics of sarcopenia in frail older adults at ambulatory clinics", will be linked to this study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'frailty', 'chronic disease control', 'aging psychology'], 'conditions': ['Ambulatory Geriatric Outpatients at High Risk of Frailty']}, 'descriptionModule': {'briefSummary': 'Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities and ageing psychology on the outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed after frailty being considered in the elderly with co-morbidity condition. In addition, the conceptual framework and corresponding measuring instrument of "mental frailty" will be expected developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulatory geriatric outpatients aged 65 and over from NTUH', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria : compatible one of following conditions\n\n* functional decline in recent one year\n* cognitive function decline\n* depressive symptom\n* mobility impairment\n* fall in recent one year\n* eating or feeding problems/weight loss\n* co-morbid conditions≧5\n* tracking by different physician ≧3 in recent half year\n* polypharmacy≧8 in recent 3 months\n* hospitalization ≧1 in recent one year\n* emergency visits≧2 in recent one year\n* aged ≧ 80\n\nExclusion criteria:\n\n* non-ambulatory (bed-ridden) patients\n* long-term residents at nursing homes\n* patients with a life expectancy shorter than six months\n* impairment in vision, hearing, or communicative ability\n* making convenience of clinical evaluation during the study period impossible.'}, 'identificationModule': {'nctId': 'NCT02160093', 'briefTitle': 'Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients', 'orgStudyIdInfo': {'id': '201404030RIND'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ching-Yu Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University, College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}