Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)
研究概览
简要总结
Malnutrition and inappropriate medication prescribing are highly prevalent among acutely admitted older medical patients leading to re-admissions, frailty, poor physical, performance compromised quality of life and mortality. Thus, the aim of this study is to optimise the nutrition and medication in older medical patients admitted to an acute care department at admission and up to 16 weeks after discharge. Participants in the intervention group receives a medication review and participants with malnutrition or risk of malnutrition additionally receive a transitional multimodal intervention. The control group receives standard care.
详细描述
The OptiNAM study is designed as a single-blinded randomised controlled trial starting upon admission and continues till 16 weeks after discharge. The trial has five sub-studies with three independent primary endpoints, all with individual sample size calculations.
The study consists of an intervention group and a control group. The control group receives standard care.
Patients that meet all inclusion criteria and none of the exclusion criteria are invited to participate. After signing a written informed consent, the participants are block randomised to either the intervention or control group.
The intervention group receives a personalised rehabilitation program, which is described below. Outcome measures are performed at baseline, week 8 and week 16 after after discharge, cf. section regarding outcome measures.
Sub study 1, Malnutrition:
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)
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
- •≥65 years
- •Acutely admitted medical patients
- •Understand and speak Danish
- •Caucasian
- •Resident in Municipality: Brøndby, Hvidovre or Copenhagen
排除标准
- •Unable to cooperate cognitively
- •Terminal/suicidal patients
- •Patients in isolation
研究组 & 干预措施
Optimisation of nutrition and medication
N=approx.
65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.
干预措施: Optimisation of nutrition and medication (Other)
Standard care
N= approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.
结局指标
主要结局
Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)
时间窗: Baseline (admission day), week 8 and week 16.
Patient administered quality of life scoring system with focus on mobility, daily activities, pain and discomfort and depression.
Changes in Medication Appropriateness Index-score" (sub-study 2)
时间窗: Baseline (admission day), week 8 and week 16.
Medical physician, geriatric or senior pharmacist perform the MAI-scoring to evaluate the appropriateness of the medication prescribing.
Accuracy of renal function estimates (sub-study 3) - cystatin C
时间窗: Baseline (admission day) or no later than 14 days after admission
Differences between GFR measured by a renally excreted radioactive labeled isotope (chromium 51-Cr-EDTA or 99mTc diethylenetriaminepentaacetic acid) and estimated GFR based on Creatinine and Cystatin C or a combination of the biomarkers.
次要结局
- Assessment of dietary intake after admission(Week 8 and week 16)
- Functional measurement to evaluate the development in physical performance(Baseline (admission day), week 8 and week 16.)
- Frailty assessment(Baseline (admission day), week 8 and week 16.)
- Cognitive performance(Week 8 and week 16)
- Anthropometric measurement to monitor changes in bodyweight(Baseline (admission day), week 8 and week 16.)
- Patient records(Baseline (admission day), week 8 and week 16.)
- Potentially inappropriate medication to elderly(Baseline (admission day), week 8 and week 16.)
- Accuracy of renal function estimates - all biomarkers(Baseline (admission day) or no later than 14 days after admission.)
- Dosing discrepancies of renal risk medication(Baseline (admission day) or no later than 14 days after admission.)
- Measure of physically active time and number of steps taken(Week 1, week 8 and week 16 after discharge)
- Cognitive test aiming to evaluate cognitive function(Baseline (admission day), week 8 and week 16)
- Intestinal microbiome composition(Baseline (admission day), week 8 and week 16 after discharge.)
- Body composition(Up to three weeks after admission during kidney function measurement)
- Walking speed to evaluate the development in physical performance(Baseline (admission day), week 8 and week 16.)
- Standard admission blood work(Baseline (admission day), week 8 and week 16.)
- Evaluation of medication under-prescribing(Baseline (admission day), week 8 and week 16)
- Inflammatory marker to evaluate the inflammatory state(Baseline (admission day), week 8 and week 16.)
- Nutritional status(Baseline (admission day), week 8 and week 16.)
- Quality of life score, WHO-5(Baseline (admission day), week 8 and week 16)
- Polypharmacy(Baseline (admission day), week 8 and week 16.)
- Acceptance of suggested changes in medications(Baseline (admission day), week 8 and week 16.)
- Body composition(Baseline (admission day), daily through out admission, up to three weeks after admission during kidney function measurement, week 8 and week 16 after discharge.)
研究者
Ove Andersen
Head of Clinical Research Centre
Hvidovre University Hospital