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

NCT05962203 | Not Yet Recruiting

• 1 other identifier: BB 161/22
• Study Type: interventional
• Target: 820
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Frailty Syndrome

Keywords

Chronic kidney disease; Frailty; Falls; Cognitive decline; Multi-component interventions; Rural communities

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Frailty transition

  36 months

• mGFR transition

  36 months

• patient welfare

  36 months

• ability to live independently

  36 months

• cognitive decline

  36 months

Study Arms (1)

Multi-factorial geriatric assessment, monitoring & management systems

EXPERIMENTAL

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

Interventions

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

Also known as: Community-based and home-based exercise programs

Multi-factorial geriatric assessment, monitoring & management systems

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• bedridden
• palliative
• inability to consent
• severe dementia
• inability to speak
• lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)

Sponsors & Collaborators

• University Medicine Greifswald: lead

MeSH Terms

Conditions

Frailty; Renal Insufficiency, Chronic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maik Gollasch, MD, PhD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maik Gollasch, MD, PhD

CONTACT

+493836257594; maik.gollasch@med.uni-greifswald.de

Julia Rüdebusch, PhD

CONTACT

+49 (0) 3834-86-7423; julia.ruedebusch@uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share