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

Frailty Syndrome Clinical Trial

— MV-FIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05962203
• Other study ID #: BB 161/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: July 2023
• Source: University Medicine Greifswald
• Contact: Maik Gollasch, MD, PhD
• Phone: +493836257594
• Email: maik.gollasch[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 820
• Est. completion date: December 31, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	body weight loss	unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above	36 months
Primary	slow walking pace	slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above	36 months
Primary	exhaustion	self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above	36 months
Primary	muscle weakness	muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above	36 months
Primary	low physical activity	(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above	36 months
Secondary	Frailty transition	Frailty transition (pre-frailty, in which one or two criteria (see above) are present)	36 months
Secondary	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
Secondary	patient welfare	self-reported patient welfare (questionnaire)	36 months
Secondary	ability to live independently	self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))	36 months
Secondary	cognitive decline	cognitive decline	36 months
Secondary	number of falls	self-reported number of falls	36 months
Secondary	admission to hospitals	self-reported admission to hospitals	36 months
Secondary	referrals to nursing homes	self-reported referrals to nursing homes	36 months
Secondary	mortality	all-cause mortality in primary care	36 months