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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorUniversity Medicine Greifswald

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Multi-factorial geriatric assessment, monitoring & management systems

    Diagnostic test

    Multi-factorial geriatric assessment, monitoring \& management systems, e.g. community-based and home-based exercise programs, polypharmacy

Treatment groups

820 Participants
are divided into 1 treatment group
Group A: Multi-factorial geriatric assessment, monitoring & management systemsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
from baseline to follow-up at 36 month
2

body weight loss

unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above

Time frame
36 months
3

slow walking pace

slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above

Time frame
36 months
4

exhaustion

self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above

Time frame
36 months

Secondary outcomes

1

Frailty transition

Frailty transition (pre-frailty, in which one or two criteria (see above) are present)

Time frame
36 months
2

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)

Time frame
36 months
3

patient welfare

self-reported patient welfare (questionnaire)

Time frame
36 months
4

ability to live independently

self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))

Time frame
36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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