SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania

Not Applicable

Not yet recruiting

Interventions: Diagnostic Test: Multi-factorial geriatric assessment, monitoring & management systems

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

bedridden
palliative
inability to consent
severe dementia
inability to speak
lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)

Arm && Interventions

Group	Intervention	Description
Multi-factorial geriatric assessment, monitoring & management systems	Multi-factorial geriatric assessment, monitoring & management systems	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

Primary Outcome Measures

Name	Time	Method
body weight loss	36 months	unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above
Frailty	from baseline to follow-up at 36 month	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.
slow walking pace	36 months	slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above
muscle weakness	36 months	muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above
exhaustion	36 months	self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above
low physical activity	36 months	(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above

Secondary Outcome Measures

Name	Time	Method
number of falls	36 months	self-reported number of falls
admission to hospitals	36 months	self-reported admission to hospitals
ability to live independently	36 months	self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))
Frailty transition	36 months	Frailty transition (pre-frailty, in which one or two criteria (see above) are present)
referrals to nursing homes	36 months	self-reported referrals to nursing homes
mGFR transition	36 months	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)
patient welfare	36 months	self-reported patient welfare (questionnaire)
cognitive decline	36 months	cognitive decline
mortality	36 months	all-cause mortality in primary care