NCT Number: NCT05962203
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.
Trial opening soon.
Get Notified65 year–100 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multi-factorial geriatric assessment, monitoring & management systems, e.g. community-based and home-based exercise programs, polypharmacy
Other names: Community-based and home-based exercise programs
Time frame: 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.
Time frame: 36 months
unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above
Time frame: 36 months
slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above
Time frame: 36 months
self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above
Time frame: 36 months
muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above
Time frame: 36 months
(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above
Time frame: 36 months
Frailty transition (pre-frailty, in which one or two criteria (see above) are present)
Time frame: 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)
Time frame: 36 months
self-reported patient welfare (questionnaire)
Time frame: 36 months
self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))
Time frame: 36 months
cognitive decline
Time frame: 36 months
self-reported number of falls
Time frame: 36 months
self-reported admission to hospitals
Time frame: 36 months
self-reported referrals to nursing homes
Time frame: 36 months
all-cause mortality in primary care
Contact information is provided by the study sponsor or research team.
Julia Rüdebusch, PhD
CONTACT
Maik Gollasch, MD, PhD
CONTACT
University Medicine Greifswald
Other
SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.
Acronym: MV-FIT
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