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

NCT ID: NCT05962203

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 820 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2029-12-31

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.

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.

Conditions

Frailty Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multi-factorial geriatric assessment, monitoring & management systems

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Multi-factorial geriatric assessment, monitoring & management systems

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Community-based and home-based exercise programs

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maik Gollasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Central Contacts

Maik Gollasch, MD, PhD

Role: CONTACT

maik.gollasch@med.uni-greifswald.de

+493836257594

Julia Rüdebusch, PhD

Role: CONTACT

julia.ruedebusch@uni-greifswald.de

+49 (0) 3834-86-7423

Other Identifiers

BB 161/22

Identifier Type: -

Identifier Source: org_study_id