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NCT Number: NCT02703441

FoodnGo-Empower: A Feasibility Study of Physical Activities and Nutrition of Older Patients by the Use of Technology

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, Copenhagen University Herlev

Herlev, 2730, Denmark

About this study

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:

  • to test if an adjusted version of the Food´n´Go technology through active involvement of the elderly patient can prevent weight loss and loss of muscle strength during hospitalization and after discharge
  • to develop and test the technology in relation to stability, applicability and acceptability

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

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

Treatment and study plan

Tablet computer

Other

Patients randomized to the intervention group will receive a tablet computer with an app-like software solution supporting nutrition and physical activity. The patients operate the computer and order their meals from the hospital menu; register dietary intake, and receive feedback informing about their current status for protein and energy intake. Likewise, the patients use small series of brief videos instructing in daily life activities for strengthening their muscles. After this, they register their performed activities and will receive informing and motivating feedback. Nudging and prompting is part of the solution.

Other names: Malnutrition and physical activity

Primary outcomes

  1. Change in lean body-mass

    Time frame: Baseline, 6 weeks and 12 weeks

    DEXA scanning,

Secondary outcomes

  1. Change in muscle strength

    Time frame: baseline, 6 and 12 weeks

    handgrip strength

  2. Change in muscle strength

    Time frame: baseline, 6 and 12 weeks

    chair-stand-test

  3. Change in weight

    Time frame: baseline, 6 and 12 weeks

  4. Change in BMI

    Time frame: baseline, 6 and 12 weeks

  5. Change in Health related Quality of Life

    Time frame: baseline, 6 and 12 weeks

    EQ5D (European Quality 5Dimensions Scale)

  6. Change in signs of depression

    Time frame: Baseline, 6 and 12 weeks

    Geriatric Depression Scale 5 (GDS5)

  7. Number of days to first readmission

    Time frame: 24 weeks

    Danish National Patient Register

  8. Mortality

    Time frame: 24 weeks

    Danish National Patient Register

Other outcomes

  1. Physical activity

    Time frame: 12 weeks

    Registered by the patient at the computer

  2. Dietary intake

    Time frame: 12 weeks

    Registered by the patient at the computer

  3. Technology functionality

    Time frame: 12 weeks

    Research assistant observes and registers problems

  4. Technology stability

    Time frame: 12 weeks

    Research assistant observes and registers problems

  5. Technology acceptability

    Time frame: 12 weeks

    Qualitative interviews with patients and relatives

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Tachista

Registry information

Official study title

FoodnGo - Empower: A Feasibility Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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