Cater With Care Effect Study (CwC)
Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.
研究概览
详细说明
Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral nutritional supplements if needed. Still, a considerable part of these patients are unable to meet protein requirements and are still at risk of undernutrition at hospital discharge. This may impair recovery of illness, partly due to loss of muscle mass and physical performance. To improve protein intake, Cater with Care products have been developed: a selection of foods and drinks that are consumed often by elderly persons, but now enriched with protein up to 10 grams per portion. We hypothesize that these products help to reach protein requirements in elderly patients during and after hospital stay and thereby improve their health outcomes.
Objective: To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly patients.
Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a hospital phase including all admitted patients and a home phase with a selection of patients.
Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.
Intervention: The control group receives the standard hospital menu for elderly at risk of undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are non-enriched variants of Cater with Care products (e.g. normal fruit juice).
The intervention group receives Cater with Care protein-enriched foods and drinks during hospital stay (in addition to the standard hospital menu) and at home as part of their home diet for 12 weeks.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Gelderland
-
Ede、Gelderland、荷兰、6716 RP
- Hospital Gelderse Vallei
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Hospital phase:
- admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei
- aged 65 years or over
- being eligible for receiving a standard protein enriched menu based on hospital protocol
- Home phase:
- included in the hospital phase of the study
- consent to continue treatment and study participation after hospital discharge
Exclusion Criteria:
- Hospital phase:
- unwilling to give consent for gathering data from the medical record or meal service system
- unable to understand Dutch
- food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff
- expected length of hospital stay less than 4 days
- renal insufficiency (eGFR < 30 ml/min)
- starting with tube feeding or total parenteral nutrition within 2 days of admission
- refeeding syndrome score > 0 based on hospital screening tool for refeeding risk
- delirium at admission
- receiving palliative care
- Home phase:
- going to a nursing home, rehabilitation centre or hospice after hospital discharge
- cognitive impairment or diagnosed with dementia
- legally incapacitated
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
|
The intervention group receives CwC protein enriched products.
After discharge the intervention group receives CwC products delivered at home for 12 weeks.
其他名称：
|
|
有源比较器：Usual menu
The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
|
The control group receives the usual menu, which is energy and protein rich in this elderly patient group.
After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Protein intake and Physical functioning at 6 months
大体时间：6 months
|
This study has 2 primary outcomes: protein intake and physical functioning.
These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in muscle strength from baseline to 6 months.
大体时间：6 months
|
Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
|
6 months
|
|
Change in nutritional status from baseline to 6 months.
大体时间：6 months
|
Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
|
6 months
|
|
Change in Quality of Life from baseline to 6 months.
大体时间：6 months.
|
Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
|
6 months.
|
|
Change in Activities of Daily Living from baseline to 6 months.
大体时间：6 months
|
Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).
|
6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BMI
大体时间：6 months
|
BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.
|
6 months
|
|
Physical Activity
大体时间：6 months
|
Physical Activity will be assessed by using the LAPAQ questionnaire.
|
6 months
|
|
Length of hospital stay
大体时间：12 weeks
|
The length of hospital stay will be recorded to include in an economic evaluation.
|
12 weeks
|
|
Costs of hospital stay
大体时间：12 weeks
|
After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
|
12 weeks
|
合作者和调查者
调查人员
- 首席研究员：Nicole M de Roos, PhD、Wageningen University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Protein enriched products的临床试验
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; InCor Heart Institute完全的白细胞疾病 | 全身炎症反应综合征 (SIRS) | 冠状动脉旁路移植术引起的并发症