Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 28
- 主要终点
- time to death from any cause (i.e., all-cause mortality)
研究概览
简要总结
This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.
详细描述
Malnutrition is a strong and independent long-term risk factor for mortality, rehospitalisation and functional decline, particularly in the elderly, polymorbid medical patient population. The randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT, Lancet 2019) included 2028 patients in eight Swiss hospitals and found that nutritional support during the inhospital stay reduces very efficiently the risk for complications and mortality with numbers needed to treat (NNT) of 23 and 37, respectively.
Yet, the nutritional intervention was not continued after hospital discharge of patients and long-term follow-up data of patients showed a lack of sustained effect of the initial nutritional support strategy. There is a current lack of trial data investigating whether long-term use of nutritional support has a sustained effect on clinical outcomes in this patient population. This study is to compare the continuous use of nutritional support with the use of approved oral nutritional supplements to reach protein and energy goals and to analyze whether medical patients at nutritional risk show a sustained benefit from long-term nutritional support after hospital discharge, and why and how nutritional support affects the course of disease from a mechanistic physio-pathological standpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This trial is single blinded (regarding outcome assessment)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Adult (age ≥18 years), medical patients
- •Nutritional risk screening using the Nutritional Risk Screening (NRS): total score ≥3 points consisting of ≥1 points for impairment of the nutritional status [weight loss >5% in 3 month or food intake of 50-75% in the last week before hospital admission] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidney disease, chronic heart failure, COPD) and other chronic diseases according to the definition of the "National Center for Chronic Disease Prevention and Health Promotion": Chronic diseases are defined broadly as conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both .
排除标准
- •after surgery
- •unable to ingest oral nutrition
- •need for long-term nutrition,
- •terminal condition
- •acute pancreatitis or acute liver failure
- •patients discharged to a nursing home
- •patients unlikely to comply with nutritional support treatment (e.g., dementia)
- •COVID-Hospitalisation requiring intensive care
结局指标
主要结局
time to death from any cause (i.e., all-cause mortality)
时间窗: Enrollment to 3 years
time to death from any cause (i.e., all-cause mortality)
次要结局
- Time to non-elective hospital readmission after discharge from the index hospital stay(assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)])
- Time to the first major complication(assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)])
- Changes in functional status measured by the Barthel's index(assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)])
- Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)(assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)])
- Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)(assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)])
研究者
Philipp Schuetz
Prof. Dr. med.
Kantonsspital Aarau