Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 2:09 PM
Study NCT ID:
NCT03513159
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Transition From Hospital to Home for Older Patients in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The patients data will be anonymized and entered into an electronic Case Report form. The Outcomes Assessor will only see the anonymized data.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Intervention Group will be supported by the activities of the pathfinder, the Control Group will not. Both Groups will be tested for functional and nutritional Status and for Quality of life and stress scores.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmission Rate', 'timeFrame': 'up to 12 months', 'description': 'The number of readmissions of a patient into a hospital within up to 15 months (study period for the patient.plus 3 months prior to enrollment).'}], 'secondaryOutcomes': [{'measure': 'Functionality and mobility - 1', 'timeFrame': 'up to 12 months', 'description': 'Timed up and Go in seconds'}, {'measure': 'Functionality and mobility - 2', 'timeFrame': 'up to 12 months', 'description': 'Instrumental activities of daily living (IADL) in scale'}, {'measure': 'Functionality and mobility - 3', 'timeFrame': 'up to 12 months', 'description': 'handgrip strength in kilogramms'}, {'measure': 'Functionality and mobility - 4', 'timeFrame': 'up to 12 months', 'description': 'pedometer activPAL3 micro'}, {'measure': 'Functionality and mobility - 5', 'timeFrame': 'up to 12 months', 'description': 'Short physical performance battery (SPPB) in scale'}, {'measure': 'Nutritional status', 'timeFrame': 'up to 12 months', 'description': 'measured bei Mini Nutritional Assessment (MNA)'}, {'measure': 'Health-related quality of life', 'timeFrame': 'up to 12 months', 'description': 'Measured by Short-Form-Health Survey (SF-12) questionnaire in scale'}, {'measure': 'Depression', 'timeFrame': 'up to 12 months', 'description': 'Measured by Geriatric Depression Scale (GDS) in scale'}, {'measure': 'Cognitive Status - 1', 'timeFrame': 'up to 12 months', 'description': 'Measured by Mini-Mental State Examination (MMSE) in scale'}, {'measure': 'Cognitive Status - 2', 'timeFrame': 'up to 12 months', 'description': 'Trail Making Test A\\&B in seconds'}, {'measure': 'Burden of informal caregivers - 1', 'timeFrame': 'up to 12 months', 'description': 'Measured by Zarith-questionnaires in scale'}, {'measure': 'Burden of informal caregivers - 2', 'timeFrame': 'up to 12 months', 'description': 'Perceived Stress Questionnaire (PSQ)-questionnaires in scale'}, {'measure': 'Transfers into nursing homes', 'timeFrame': 'Up to 12 months', 'description': 'Comparison between intervention and control group. Data made available by cooperating partner Allgemeine Ortskrankenkasse (AOK) sickness fund in percent'}, {'measure': 'Care situation, care supply and quality of care at home', 'timeFrame': 'up to 12 months', 'description': 'Measured by Neues BegutAchtungsinstrument (NBA, Buscher, Wingenfeld \\& Schaeffer, 2011) as scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transitional care, geriatric, readmission,', 'discharge', 'quality of life'], 'conditions': ['Geriatric Patients in the Transition From Hospital to Home']}, 'referencesModule': {'references': [{'pmid': '34488636', 'type': 'DERIVED', 'citation': 'Gehr TJ, Freiberger E, Sieber CC, Engel SA. A typology of caregiving spouses of geriatric patients without dementia: caring, worried, desperate. BMC Geriatr. 2021 Sep 6;21(1):483. doi: 10.1186/s12877-021-02425-1.'}, {'pmid': '33558344', 'type': 'DERIVED', 'citation': 'Rimmele M, Wirth J, Britting S, Gehr T, Hermann M, van den Heuvel D, Kestler A, Koch T, Schoeffski O, Volkert D, Wingenfeld K, Wurm S, Freiberger E, Sieber C; TIGER consortium. Improvement of transitional care from hospital to home for older patients, the TIGER study: protocol of a randomised controlled trial. BMJ Open. 2021 Feb 8;11(2):e037999. doi: 10.1136/bmjopen-2020-037999.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the transsectoral care project TIGER is the reduction of readmission rates of geriatric patients. This aim shall be achieved by improving the hitherto inadequate care process for geriatric patients in the transition from hospital to home. The program offers substantial support of patients and their informal caregivers in the transition process from hospital to home via so called pathfinders, specialized nurses in geriatrics.The pathfinders effectively intertwine stationary and ambulatory care teams caring for a patient, thereby augmenting and complementing effective hospital release management.', 'detailedDescription': 'Especially for older, chronically ill persons, a hospital stay can promote significant losses in functionality, independence and quality of life, and can increase nutrition deficits and the risk for infections, leading to the occurrence of severe gaps in care after hospital release and to an increased risk for readmission rates.\n\nEven if the German government has recognized the necessity of a multiprofessional integrated care program for older, vulnerable patients and has installed a hospital release management program situated in hospitals in 2012, clarifying entitlements to benefits and setting up ambulatory services contacts, this does not yet meet the complex needs of geriatric patients and their informal caregivers.\n\nInternationally, the Transitional Care Model (TCM) has been developed (M. Naylor et al. 1994) to address the deficits in care of older patients in transition between hospital to home. Via a series of defined activities, a disruption of the care supply chain for older patients in this transition process is being avoided.\n\nThe TIGER program will address the needs of geriatric patients and their informal caregivers and will support them via structured continuous activities, on the basis of the TCM, by so called pathfinders, nurses specialized in geriatrics. These pathfinders will develop an individual care plan with the patients, their informal caregivers and the hospital physicians already inside the hospital setting and will then develop and improve this further during up to twelve months after the hospital release of the patient. The pathfinders will coordinate the ambulatory care team services and closely involve the primary physicians. The patients and their informal caregivers will be empowered and educated to achieve a stabilization or improvement in functionality, independence, quality of life, coping with disease, nutritional status and wound healing process of the patients.\n\nThe aim of the program is that these activities will lead to a reduction of necessary readmission rates of geriatric patients.\n\nEfficacy, practicability, and limitations of the program will be evaluated scientifically and economically and will be analyzed for a possible saving of costs for the health care system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nwill go back home after Hospital stay, AOK Patient, MiniMentalStateExamination MMSE score of at least 22, is living within 50 km range of the hospital\n\nExclusion Criteria:\n\npalliative status, planned readmission into hospital within next 4 weeks'}, 'identificationModule': {'nctId': 'NCT03513159', 'acronym': 'TIGER', 'briefTitle': 'Improvement of Transition From Hospital to Home for Older Patients in Germany', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg', 'orgStudyIdInfo': {'id': 'IBA-2018-TIGER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pathfinder support', 'description': 'Pathfinder support with development of an individual care plan for the intervention patients and their informal caregivers, with the hospital physicians already inside the hospital setting. This will then be developed and improved further during up to twelve months after hospital release with the primary physician. The pathfinders will coordinate the ambulatory care team services and closely involve the primary physicians. The patients and their informal caregivers will be empowered and educated to achieve a stabilization or improvement in functionality, independence, quality of life, coping with disease, nutritional status and wound healing process. In the regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.', 'interventionNames': ['Behavioral: Pathfinder support']}, {'type': 'NO_INTERVENTION', 'label': 'Control without pathfinder support', 'description': 'Control patients will not be supported by pathfinders. In regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.'}], 'interventions': [{'name': 'Pathfinder support', 'type': 'BEHAVIORAL', 'description': 'A pathfinder will support the patient with structured activities.', 'armGroupLabels': ['Pathfinder support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93049', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Hospital of the Order of St.John of God Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '90408', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Institute for Biomedicine of Aging, University of Erlangen-Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Cornel Sieber, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute for Biomedicine of Aging'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The repository of the data set is under construction with the University.', 'ipdSharing': 'YES', 'description': 'The final anonymized trial data set will be available to the TIGER consortium. After completion of evaluation and dissemination by the TIGER-consortium, the goal is that an anonymized data set will be made available to interested Researchers upon reasonable request, being deposited in a repository of the University.\n\nDuring finalization of the study a detailed data sharing plan will be developed and introduced into this trial registry.', 'accessCriteria': 'Anonymized data set will be available to interested Researchers upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany', 'class': 'UNKNOWN'}, {'name': 'Regensburg Physicians Network RAEN', 'class': 'UNKNOWN'}, {'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'AOK Bayern', 'class': 'INDUSTRY'}, {'name': 'Institute for Nursing Sciences, University of Bielefeld, Germany', 'class': 'UNKNOWN'}, {'name': 'Federal Association for Geriatrics, Germany', 'class': 'UNKNOWN'}, {'name': 'Federal Joint Committee', 'class': 'OTHER_GOV'}, {'name': 'Institute for Community Medicine, University of Greifswald, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}