Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 3:48 AM
Study NCT ID:
NCT05452395
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-acute Care for Patients With Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019467', 'term': 'Subacute Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day emergency room visits', 'timeFrame': '90 days after post-acute care', 'description': 'Emergency room visits after post-acute care'}, {'measure': '90-day readmissions', 'timeFrame': '90 days after post-acute care', 'description': 'Readmissions visits after post-acute care'}, {'measure': '90-day mortality', 'timeFrame': '90 days after post-acute care', 'description': 'Mortality after post-acute care'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'Retrospective Study']}, 'referencesModule': {'references': [{'pmid': '36607971', 'type': 'DERIVED', 'citation': 'Lee MC, Wu TY, Huang SJ, Chen YM, Hsiao SH, Tsai CY. Post-acute care for frail older people decreases 90-day emergency room visits, readmissions and mortality: An interventional study. PLoS One. 2023 Jan 6;18(1):e0279654. doi: 10.1371/journal.pone.0279654. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Acute illness could be enormous stress for frail people. Combining comprehensive geriatric assessment and multifactorial intervention has positive effects on frail community older adults. However, few studies investigated the effects of post-acute care (PAC) in frail older patients who just recovered from acute hospitalization. This study aimed to evaluate the effects of PAC on frail older adults in Taiwan.', 'detailedDescription': 'Frail patients aged \\>= 75 were recruited and divided into PAC or control groups. The PAC group received comprehensive geriatric assessment (CGA) and multifactorial intervention for two to four weeks. The control group received CGA only. The primary outcomes were 90-day emergency room visits, readmissions, and mortality after PAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Mild to severe frailty identified by the Clinical Frailty Scale\n2. Age ≥ 75 years\n3. Diagnosis with Parkinson's disease, dementia, chronic obstructive pulmonary disease, or chronic kidney disease stage three or worse\n4. Acute hospital stays between 3 to 30 days with deconditioning\n5. Stable medical condition with no need of intensive care, laboratory examination, or oxygen dependence\n\nExclusion Criteria:\n\n1. Refused to participate in the program\n2. Candidate for other post-acute care programs (i.e. stroke, traumatic neurological injury, or fracture)\n3. Unable to cooperate with the program due to mental or cognitive impairment\n4. Long-term ventilator-dependence\n5. Long-term bed-ridden status (\\> 6 months)\n6. Diagnosed as end of life and in need of palliative care\n7. Diagnosed as major illness (i.e. end-stage renal disease) and in need of frequent inpatient treatment ( \\> 3 times over recent 6 months)\n8. Institutional residents\n9. Home medical care participants"}, 'identificationModule': {'nctId': 'NCT05452395', 'briefTitle': 'Post-acute Care for Patients With Frailty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'Integrated Post-Acute Care Program for Frail Elderly', 'orgStudyIdInfo': {'id': 'TPECH-frailty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-acute care', 'description': 'comprehensive geriatric assessment, and either home-based or hospital-based post-acute care', 'interventionNames': ['Other: Post-acute care']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'comprehensive geriatric assessment only'}], 'interventions': [{'name': 'Post-acute care', 'type': 'OTHER', 'description': 'A personalized care program, focusing on managing geriatric syndromes and improving functional performances.\n\nStrength training, activities of daily living (ADL) and instrumental activities of daily living (IADL) practice, basic mobility training, reconditioning exercise, and home environment assessment and modification.', 'armGroupLabels': ['Post-acute care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Tai-Yin Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Family Medicine, Taipei City Hospital, Zhongxing Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Tai-Yin Wu', 'investigatorAffiliation': 'Taipei City Hospital'}}}}