SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 820
- 主要终点
- body weight loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 65 years or older
- •mGFR > 30 mL/min per 1.73 m2
- •being able to understand and give written informed consent.
排除标准
- •bedridden
- •palliative
- •inability to consent
- •severe dementia
- •inability to speak
- •lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)
结局指标
主要结局
body weight loss
时间窗: 36 months
unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above
Frailty
时间窗: from baseline to follow-up at 36 month
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.
slow walking pace
时间窗: 36 months
slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above
muscle weakness
时间窗: 36 months
muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above
exhaustion
时间窗: 36 months
self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above
low physical activity
时间窗: 36 months
(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above
次要结局
- admission to hospitals(36 months)
- ability to live independently(36 months)
- Frailty transition(36 months)
- mGFR transition(36 months)
- patient welfare(36 months)
- number of falls(36 months)
- referrals to nursing homes(36 months)
- cognitive decline(36 months)
- mortality(36 months)