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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty Syndrome
• Intervention / Treatment: Diagnostic test: Multi-factorial geriatric assessment, monitoring & management systems

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.

• Study Type: Interventional
• Enrollment (Estimated): 820
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maik Gollasch, MD, PhD; Phone Number: +493836257594; Email: maik.gollasch@med.uni-greifswald.de
• Study Contact Backup: Name: Julia Rüdebusch, PhD; Phone Number: +49 (0) 3834-86-7423; Email: julia.ruedebusch@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age 65 years or older
• mGFR > 30 mL/min per 1.73 m2
• being able to understand and give written informed consent.

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: Multi-factorial geriatric assessment, monitoring & management systems; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Maik Gollasch, MD, PhD, University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive decline; Chronic kidney disease; Frailty; Falls; Rural communities; Multi-component interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: BB 161/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No