NCT03882944已完成不适用
A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 17
- 主要终点
- Nutritional Status
研究概览
简要总结
This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
- •Subject is considered malnourished, or is at risk for malnutrition
- •Subject conforms to the requirements set forth on the study product label.
- •Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation).
- •Subject has been elected for hip fracture surgery and is within three days since surgery.
- •The study physician determines the subject is fit to participate.
- •Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
- •After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay < 15 days.
排除标准
- •Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
- •Subject has active cancer and the study physician determines the subject is not suitable for the study.
- •Subject has uncontrolled diabetes.
- •Subject is known to be allergic or intolerant to any ingredient found in the study product.
- •Participation in another study that has not been approved as a concomitant study.
结局指标
主要结局
Nutritional Status
时间窗: Baseline to Week 12
Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition
次要结局
- Short Physical Performance Battery (SPPB)(Week 12)
- Barthel Index of Activities of Daily Living(Baseline to Week 12)
- Functional Ambulation Classification Scale (FAC)(Baseline to Week 12)
- Compliance with Nutritional Supplement(Baseline to Week 12)
研究者
研究点 (17)
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