About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 65 years or older
mGFR > 30 mL/min per 1.73 m2
being able to understand and give written informed consent.
Disqualifiers
bedridden
palliative
inability to consent
severe dementia
Trial design
Single group
Treatments tested in this trial
Multi-factorial geriatric assessment, monitoring & management systems
Diagnostic testMulti-factorial geriatric assessment, monitoring \& management systems, e.g. community-based and home-based exercise programs, polypharmacy
Treatment groups
Trial outcomes
Primary outcomes
Frailty
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.
body weight loss
unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above
slow walking pace
slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above
exhaustion
self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above
Secondary outcomes
Frailty transition
Frailty transition (pre-frailty, in which one or two criteria (see above) are present)
mGFR transition
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
self-reported patient welfare (questionnaire)
ability to live independently
self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))
Locations
Sponsors and contacts
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