跳至主要内容
临床试验/NCT03519139
NCT03519139已完成不适用

Individual Nutritional Intervention for the Prevention of Readmission Among Geriatric Patients - a Randomized Clinical Study

Jens Rikardt Andersen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
readmission-or hospitalization rate (%)

研究概览

简要总结

The purpose of this study is to investigate whether a four-week individual nutritional intervention can reduce the readmission/hospitalization rate among geriatric patients who are discharged to their private home or respite care. Secondarily, whether an individual nutritional intervention can improve nutritional status, functional status, quality of life, muscle strength and reduce mortality in geriatric patients after discharge Two sub-points are investigated using feasibility studies - if photography documentation of meals can be used in practice to assess the energy and protein intake of geriatric patients and whether photography documentation of the refrigerator content at first home visits in the intervention group can predict whether there is an increased risk of readmission.

详细描述

Method/Design:

The trial is conducted as a randomized clinical trial, with recruitment of 40 medical geriatric patients (definition: ≥65 years of age with at least two diagnoses, e.g. hypertension, cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, rheumatic diseases or apoplexy). At discharge the test subjects are randomized to receive either individual dietary counseling or standard treatment with follow-up 30 and 60 days after discharge. All data are collected prior to randomization. The intervention consists of three individual dietary counsellings with the aim to ensure sufficient coverage of energy and protein needs of the subjects (the first at the hospital by discharge, then in week 1 and week 3 at the subject's home/the respite care after discharge) and, if necessary, telephone follow-up in weeks 2 and 4 after discharge. The intervention group, if possible, are asked to take photos of all they eat and drink for two days before individual dietary counselling and send the photos electronically to the responsible investigators before the meeting.

Recruitment:

Only admitted patients are included in the trial. Attending physician finds the patients through the Health Platform at Sydsjællands University Hospital. The care staff or the attending physician asks whether the patient is willing to talk with the responsible investigators. The responsible investigators then make personal contact with the geriatric patients while they are hospitalized. Patients will be informed orally and in writing about the trial of the responsible investigators. Patients also receive pamphlets about test subjects rights in a health science research project published by the National Science Ethics Committee with the purpose of giving patients an informed basis to make a decision.

Patients are informed that they can take a family member or friend to the next conversation. Patients receive at least 24 hours of deliberation time, after which they are contacted by the responsible investigators. Patients who wish to participate in the trial are asked to sign a consent statement. This statement is also signed by the responsible investigator who has given the patient oral information about the trial. The subjects are offered a copy of the consent statement. To ensure uninterrupted conversation, conversation will take place in a room without other people or alternatively in the patient's room and a partition will be put of if the patient is not in a room by them self.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • recruited at Medical Department at Sjælland University Hospital, Køge (sections M1, M2, M6, L1) and discharged to one of following municipalities: Greve, Køge, Roskilde, Solrød and Stevns
  • geriatric patients according to the definition
  • competent adult and Danish speaking who are able to give written consent
  • oral nutrition possible (no tube feeding or intravenous nutrition)
  • discharged planned for home or respite care or similar (e.g. family).

排除标准

  • diagnosed dementia or under investigation for dementia
  • nursing home resident or discharged to nursing homes
  • terminal patients
  • patients who desire weight loss
  • scheduled readmission.

研究组 & 干预措施

individual dietary counselling

Experimental

three individual dietary counsellings. The first at the hospital by discharge, then in week 1 and week 3 at the subject's home/the respite care after discharge and, if necessary, telephone follow-up in weeks 2 and 4 after discharge

干预措施: individual dietary counselling (Other)

Control

No Intervention

standard counselling provided by the hospital at discharge. The standard counselling may include nutritional prescription and nutritional plan, but no follow-up to the nutrition plan after the discharge.

结局指标

主要结局

readmission-or hospitalization rate (%)

时间窗: 30 days after discharge

readmission for the same diagnosis as at discharge. Hospitalization for a new diagnosis

次要结局

  • nutritional status (%)(30 and 60 days after discharge)
  • readmission-/hospitalization rate (%)(60 days after discharge)
  • number of days between readmission or hospitalization and discharge (days)(30 and 60 days after discharge)
  • functional status (score, points)(30 and 60 days after discharge)
  • muscle strenght (dyn)(30 and 60 days after discharge)
  • Quality of Life (score, points)(30 and 60 days after discharge)

研究者

发起方
Jens Rikardt Andersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Rikardt Andersen

Associate Professor

University of Copenhagen

研究点 (2)

Loading locations...

相似试验

Individual Nutritional Intervention for the... | 临床试验