Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Total length of hospital stay and rehabilitation clinics
研究概览
简要总结
Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are:
- Does nutritional intervention reduce total length-of-stay?
- Is nutritional intervention cost-effective?
- Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness?
Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to one of the participating hospitals because of a proximal femur fracture
- •Age 55 years and older
排除标准
- •Periprosthetic or pathologic fracture
- •Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler
- •Life expectation of less than one year due to underlying disease (e.g. cancer)
- •Presence of dementia or other severely impaired cognitive function
- •Inability to communicate in Dutch language
- •Nutritional intervention prior to admission
- •Patients who are bedridden
- •Patients who are too ill or for any other reason not able to participate adequately in follow-up
结局指标
主要结局
Total length of hospital stay and rehabilitation clinics
时间窗: baseline, 3 months and 6 months after inclusion
次要结局
- Nutritional status, hip functionality, physical disability, fatigue, quality of life.(baseline, 3 months and 6 months after inclusion)
- Cost questionnaire, informal care questionnaire.(baseline, 3 months and 6 months after inclusion)
- Rate of complications(baseline, 3 months and 6 months after inclusion)