Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT05962203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 820}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frailty', 'timeFrame': 'from baseline to follow-up at 36 month', 'description': 'The primary outcome will be frailty from baseline to follow-up at 36 months post subject inclusion (i.e. Frail vs. non-Frail). The frailty phenotype defines frailty as a clinical syndrome meeting three or more of five phenotypic criteria: (1) unintentional body weight loss (2) slow walking pace, (3) self-reported exhaustion, (4) muscle weakness, and (5) self-reported low physical activity.'}, {'measure': 'body weight loss', 'timeFrame': '36 months', 'description': 'unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above'}, {'measure': 'slow walking pace', 'timeFrame': '36 months', 'description': 'slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above'}, {'measure': 'exhaustion', 'timeFrame': '36 months', 'description': 'self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above'}, {'measure': 'muscle weakness', 'timeFrame': '36 months', 'description': 'muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above'}, {'measure': 'low physical activity', 'timeFrame': '36 months', 'description': '(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above'}], 'secondaryOutcomes': [{'measure': 'Frailty transition', 'timeFrame': '36 months', 'description': 'Frailty transition (pre-frailty, in which one or two criteria (see above) are present)'}, {'measure': 'mGFR transition', 'timeFrame': '36 months', 'description': 'mGFR transition (transition from GFR KDIGO (Kidney Disease: Improving Global Outcomes) Stage 2 CKD in mL/min per 1.73 m2 to KDIGO Stage 3 in mL/min per 1.73 m2)'}, {'measure': 'patient welfare', 'timeFrame': '36 months', 'description': 'self-reported patient welfare (questionnaire)'}, {'measure': 'ability to live independently', 'timeFrame': '36 months', 'description': 'self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))'}, {'measure': 'cognitive decline', 'timeFrame': '36 months', 'description': 'cognitive decline'}, {'measure': 'number of falls', 'timeFrame': '36 months', 'description': 'self-reported number of falls'}, {'measure': 'admission to hospitals', 'timeFrame': '36 months', 'description': 'self-reported admission to hospitals'}, {'measure': 'referrals to nursing homes', 'timeFrame': '36 months', 'description': 'self-reported referrals to nursing homes'}, {'measure': 'mortality', 'timeFrame': '36 months', 'description': 'all-cause mortality in primary care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Frailty', 'Falls', 'Cognitive decline', 'Multi-component interventions', 'Rural communities'], 'conditions': ['Frailty Syndrome']}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease (CKD) is a leading risk factor for cardiovascular and all-cause mortality among the elderly. Mecklenburg-Western Pomerania has the largest prevalence of CKD in Germany and Europe. The CKD impact in primary care strategies to reduce frailty syndrome in the elderly is unknown. For this purpose, about 820 elderly participants will be included in an observational study (MV-FIT), who will undergo an multi-factorial geriatric assessment, monitoring \\& management program, specifically designed to avoid frailty. The goal of the full-scale study is to evaluate the impact of CKD in multi-component primary care strategies to reduce frailty among elderly persons in rural Mecklenburg-Western Pomerania. MV-FIT will be conducted on individuals in rural Mecklenburg-Western Pomerania, who will be observed over a period of 3 years. The Study of Health in Pomerania (SHIP) is a population-based epidemiological, two independent-cohort, study (SHIP and SHIP-TREND). SHIP cohorts have been followed for \\>24 years. SHIP/SHIP TEND participants \\>60 years or older will studied by a follow-up survey. The aim is to gain new insights into the development of frailty and to develop strategies for keeping those affected healthy.', 'detailedDescription': "Our study is a longitudinal population-based epidemiological SHIP-cohort study combined with a prospective, multi-centered, observational/interventional investigation. MV-FIT is an observational study of individuals aged 65 years or older with mGFR \\>30 mL/min (n=\\~820). All participants in the observational/interventional study will receive guideline-based, multi-factorial geriatric assessment, monitoring \\& managements (multi-component healthcare). Subjects will be stratified by mGFR. Objectives are 1) to implement multi-component healthcare specifically comprised of components to reduce frailty and incident falls, 2) to improve compliance and adherence to the multi-component healthcare for frailty and improvement of patient welfare, ability to live independently, quality-of-life, number of falls, referrals to nursing homes, all-cause mortality in primary care of the elderly, 3) to seek the elderly individuals' experience during the course of multi-factorial primary care intervention through In-depth interviews, 4) to clarify the burden of CKD on frailty and health status, and 5) to identify novel risk factors and mechanisms for frailty and pre-frailty. MV-FIT data will be corroborated by SHIP/SHIP-TREND data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 65 years or older\n* mGFR \\> 30 mL/min per 1.73 m2\n* being able to understand and give written informed consent.\n\nExclusion Criteria:\n\n* bedridden\n* palliative\n* inability to consent\n* severe dementia\n* inability to speak\n* lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)'}, 'identificationModule': {'nctId': 'NCT05962203', 'acronym': 'MV-FIT', 'briefTitle': 'SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.', 'orgStudyIdInfo': {'id': 'BB 161/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-factorial geriatric assessment, monitoring & management systems', 'description': 'All participants in the observational/interventional study (MV-FIT) will receive guideline-based, multi-factorial geriatric assessment, monitoring \\& managements (multi-component healthcare). Other: GFR Measuremments, Blood sampling, Urine sampling', 'interventionNames': ['Diagnostic Test: Multi-factorial geriatric assessment, monitoring & management systems']}], 'interventions': [{'name': 'Multi-factorial geriatric assessment, monitoring & management systems', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Community-based and home-based exercise programs'], 'description': 'Multi-factorial geriatric assessment, monitoring \\& management systems, e.g. community-based and home-based exercise programs, polypharmacy', 'armGroupLabels': ['Multi-factorial geriatric assessment, monitoring & management systems']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maik Gollasch, MD, PhD', 'role': 'CONTACT', 'email': 'maik.gollasch@med.uni-greifswald.de', 'phone': '+493836257594'}, {'name': 'Julia Rüdebusch, PhD', 'role': 'CONTACT', 'email': 'julia.ruedebusch@uni-greifswald.de', 'phone': '+49 (0) 3834-86-7423'}], 'overallOfficials': [{'name': 'Maik Gollasch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}