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

September 29, 2016 updated by: Tove Lindhardt Damsgaard, Herlev Hospital

FoodnGo - Empower: A Feasibility Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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:

  1. 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
  2. to develop and test the technology in relation to stability, applicability and acceptability

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Herlev, Denmark, 2730
        • Department of Internal Medicine, Copenhagen University Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Tablet computer
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.
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
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lean body-mass
Time Frame: Baseline, 6 weeks and 12 weeks
DEXA scanning,
Baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength
Time Frame: baseline, 6 and 12 weeks
handgrip strength
baseline, 6 and 12 weeks
Change in muscle strength
Time Frame: baseline, 6 and 12 weeks
chair-stand-test
baseline, 6 and 12 weeks
Change in weight
Time Frame: baseline, 6 and 12 weeks
baseline, 6 and 12 weeks
Change in BMI
Time Frame: baseline, 6 and 12 weeks
baseline, 6 and 12 weeks
Change in Health related Quality of Life
Time Frame: baseline, 6 and 12 weeks
EQ5D (European Quality 5Dimensions Scale)
baseline, 6 and 12 weeks
Change in signs of depression
Time Frame: Baseline, 6 and 12 weeks
Geriatric Depression Scale 5 (GDS5)
Baseline, 6 and 12 weeks
Number of days to first readmission
Time Frame: 24 weeks
Danish National Patient Register
24 weeks
Mortality
Time Frame: 24 weeks
Danish National Patient Register
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 12 weeks
Registered by the patient at the computer
12 weeks
Dietary intake
Time Frame: 12 weeks
Registered by the patient at the computer
12 weeks
Technology functionality
Time Frame: 12 weeks
Research assistant observes and registers problems
12 weeks
Technology stability
Time Frame: 12 weeks
Research assistant observes and registers problems
12 weeks
Technology acceptability
Time Frame: 12 weeks
Qualitative interviews with patients and relatives
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Tove L. Damsgaaard, Ph.D., Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-O-FNG-2015-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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