Clinical trial NCT05962203: SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania
Official title: SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty Syndrome
Keywords: Chronic kidney disease
Frailty
Falls
Cognitive decline
Multi-component interventions
Rural communities
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 820
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Frailty
timeFrame: from baseline to follow-up at 36 month
measure: body weight loss
timeFrame: 36 months
measure: slow walking pace
timeFrame: 36 months
measure: exhaustion
timeFrame: 36 months
measure: muscle weakness
timeFrame: 36 months
measure: low physical activity
timeFrame: 36 months
Secondary outcomes:
measure: Frailty transition
timeFrame: 36 months
measure: mGFR transition
timeFrame: 36 months
measure: patient welfare
timeFrame: 36 months
measure: ability to live independently
timeFrame: 36 months
measure: cognitive decline
timeFrame: 36 months
measure: number of falls
timeFrame: 36 months
measure: admission to hospitals
timeFrame: 36 months
measure: referrals to nursing homes
timeFrame: 36 months
measure: mortality
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: University Medicine Greifswald
name: Maik Gollasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: