HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Five Times Sit to Stand Test
研究概览
简要总结
Because of short hospital stays, and nutritional status worsening for geriatric patients, time to improve this is limited. It seems necessary to integrate nutritional support after discharge, to prevent the consequences of malnutrition on health and physical capability. This study tests whether nutrition support using NCP (Nutrition Care Process) (1) in combination with delivered meals designed for old adults, improves nutritional status, muscle strength, physical function, quality of life and rehospitalization and mortality rates after discharge, compared to currently used care (2 = control) along with historical data. Participants (N = 200), will be randomized into two groups, the intervention will last 24 weeks. A dietitian (Ph.D. student) visits participants in the intervention group 5 times during the study period. Outcome parameters will be measured before discharge from the hospital, at 12 weeks and at 24 weeks. Data on hospital readmission and mortality will be followed up at 6 months after the intervention.
Condition or disease: Malnutrition Intervention/treatment: NCP by a dietitian and free food constructed to fulfill protein and energy needs for the group.
详细描述
Malnutrition is common in older people admitted to the hospital and can worsen after discharge. Therefore, it seems necessary to integrate nutritional support not only during the hospital stay but also in the period after discharge. The aim of this Randomized Controlled Trial (RCT) is to test whether nutritional support provided by a dietitian, using Nutrition Care Process in combination with delivered meals designed for the needs of older adults (group 1), improves nutritional status, muscle strength, physical function, quality of life and as a secondary outcome re-hospitalization and/or mortality of geriatric patients with malnutrition risk after discharge compared to currently used standard care (group 2 = control).
Time and work plan:
After 12 months
- Need identification and product ideas ready
- Packaging material ready
- Estimate of the feasibility of meals for old adults
- Allowances from the ethical committee, the data protection committee, the Ph.D. committee of the Faculty of Food Science and Nutrition at the University of Iceland.
After 24 months
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the geriatric units at the University Hospital of Iceland discharging home to independent living
- •A score of 20 or above on the Mini-Mental State Evaluation (MMSE) form
- •Being at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
- •The capability of eating orally
排除标准
- •Living at a nursing home
- •MMSE score of under 20
- •No nutritional risk
结局指标
主要结局
Five Times Sit to Stand Test
时间窗: Measurement at 24 weeks
Part of short physical performance battery, yes vs no
Protein intake
时间窗: Measurement at 24 weeks
Protein intake in g/day
Balance test
时间窗: Measurement at 24 weeks
Part of short physical performance battery, yes vs no
Body weight
时间窗: Measurement at 24 weeks
Body weight in kilograms
Energy intake
时间窗: Measurement at 24 weeks
Energy in kilocalories per 24 hours
Health Related Quality of Life (HRQL)
时间窗: Measurement at 24 weeks
EQ-5D including SRH
Depression
时间窗: Measurement at 24 weeks
Center for Epidemiologic Studies Depression scale
Cognitive function
时间窗: Measurement at 24 weeks
MMSE
Fluid intake
时间窗: Measurement at 24 weeks
Fluid intake evaluated
Upper arm circumference
时间窗: Measurement at 24 weeks
Measured in centimeters
Waist circumference
时间窗: Measurement at 24 weeks
Measured in centimeters
calf circumference
时间窗: Measurement at 24 weeks
Measured in centimeters
Grip strength
时间窗: Measurement at 24 weeks
Measured in lbs
lean body mass
时间窗: Measurement at 24 weeks
Measured with BIA (kg)
Nutrition status
时间窗: Measurement at 24 weeks
Icelandic Nutrition Screening Tool (score)
次要结局
- Re-hospitalization(at 12 months from recruitment to trial)
- Mortality(at 12 months from recruitment to trial)
研究者
Alfons Ramel
Professor
University of Iceland