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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Frailty [Срок оценки: from baseline to follow-up at 36 month]
• body weight loss [Срок оценки: 36 months]
• slow walking pace [Срок оценки: 36 months]
• exhaustion [Срок оценки: 36 months]
• muscle weakness [Срок оценки: 36 months]
• low physical activity [Срок оценки: 36 months]

Вторичные конечные точки (9)

• Frailty transition [Срок оценки: 36 months]
• mGFR transition [Срок оценки: 36 months]
• patient welfare [Срок оценки: 36 months]
• ability to live independently [Срок оценки: 36 months]
• cognitive decline [Срок оценки: 36 months]
• number of falls [Срок оценки: 36 months]
• admission to hospitals [Срок оценки: 36 months]
• referrals to nursing homes [Срок оценки: 36 months]
• mortality [Срок оценки: 36 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05962203 · BB 161/22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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