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临床试验/NCT02703441
NCT02703441已完成不适用

FoodnGo - Empower: A Feasibility Study

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年5月1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
入组人数
38
试验地点
1
主要终点
Change in lean body-mass

研究概览

简要总结

The research and innovation programme Food´n´Go - Empower aims to develop, test and implement health technology solutions for active involvement and increased empowerment of elderly patients and their relatives solving well-known problem areas as malnutrition and inactivity.

The prototype was developed in 2013. The project is a collaboration between departement of internal medicine in Copenhagen University Hospital, one local municipality and a private it-company. The technology is a tablet computer, used by elderly patients to order and register food intake during hospitalization. The tablet is also used to get inspiration for physical activities during hospital admission and after discharge and for registration of physical activities.

The aim of this study is to test if an adjusted version of the Food´n´Go technology through active involvement of the elderly patient can prevent weightloss and loss of muscle strength during hospitalization and after discharge.

详细描述

Welfare and health technology are often directed at solving problems and meeting the needs of societies' most vulnerable groups often not familiar with computers.

The research and innovation programme Food´n´Go - Empower aims to develop, test and implement health technology solutions for involvement and increased empowerment of elderly patients and their relatives. The focus is on frequent issues for this group of patients, in this phase focusing on nutrition and physical activity. Later, the solution will include pain management, management of sleep problems, medication management, prevention of confusion and coordination of the treatment and care course across sectorial borders. The technology is a tablet- computer, operated by the patient by means of a number of app-like software applications.

In the summer 2013 the programme received a grant from the Capitol Region's Public-Private-Innovation (OPI) pool for design and development of the prototype. In 2014 the prototype for nutrition was tested in a feasibility study. Usability and acceptability was tested in the patients' own home, as well as the effect of the nutrition intervention, after discharge from hospital (see protocol 10/16/2014).

The results were promising, and the aim is now to test the technology for supporting both nutrition and physical activity across sectorial boundaries. The elderly patient will operate the tablet during admission and after discharge, continuing the efforts aimed at nutrition and physical activity during the stay at a rehabilitation centre 5 to 6 weeks after discharge. The working hypothesis is: Functional ability and nutritional status will be stabilized or improved, and readmissions and dependency of municipal services will be reduced.

The aim of this study is:

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
否

入选标准

  • •≥ 65 years old admitted to Department of Internal Medicine
  • •Planned to be discharged to a temporary stay at the municipality training centre
  • •Body Mass Index ≤ 20
  • •Patient experienced problems with solving daily physical activities
  • •Minimal Mental State Examination (MMSE) ≥24
  • •Able to operate the computer
  • •Able to collaborate in the physical activities
  • •Has a relative who is willing to be supportive

排除标准

  • •Terminal patients
  • •Patients who are not able to communicate or do not understand danish

研究组 & 干预措施

Intervention: Tablet computer

Experimental

Patients from the local municipality, planned to be discharged to a rehabilitation stay at the municipality training centre receive a tablet computer. The patient will be introduced to the tablet and informed about the nutritional and mobilisation intervention based on his/her individual needs and preferences. The patient and the research assistant will jointly prepare an individual plan for nutrition and physical activity The patient uses the tablet for ordering meals, registering dietary intake, viewing his/her instruction videos for the activity programme and registering physical activity during hospital admission and at the training centre up to 6 weeks after discharge from hospital.

干预措施: Tablet computer (Other)

Control group

No Intervention

Patients in the control group receive usual care during their hospital stay and after discharge at the municipality training centre. Data are recorded at baseline and 6 and 12 weeks after discharge.

结局指标

主要结局

Change in lean body-mass

时间窗: Baseline, 6 weeks and 12 weeks

DEXA scanning,

次要结局

  • Number of days to first readmission(24 weeks)
  • Change in muscle strength(baseline, 6 and 12 weeks)
  • Change in weight(baseline, 6 and 12 weeks)
  • Change in Health related Quality of Life(baseline, 6 and 12 weeks)
  • Change in BMI(baseline, 6 and 12 weeks)
  • Change in signs of depression(Baseline, 6 and 12 weeks)
  • Mortality(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tove Lindhardt Damsgaard

senior researcher

Herlev Hospital

研究点 (1)

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