Clinical trial NCT02703441: FoodnGo-Empower: A Feasibility Study of Physical Activities and Nutrition of Older Patients by the Use of Technology
Official title: FoodnGo - Empower: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Physical Activity
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Tachista
First posted: 2016-03-09
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in lean body-mass
timeFrame: Baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Change in muscle strength
timeFrame: baseline, 6 and 12 weeks
measure: Change in muscle strength
timeFrame: baseline, 6 and 12 weeks
measure: Change in weight
timeFrame: baseline, 6 and 12 weeks
measure: Change in BMI
timeFrame: baseline, 6 and 12 weeks
measure: Change in Health related Quality of Life
timeFrame: baseline, 6 and 12 weeks
measure: Change in signs of depression
timeFrame: Baseline, 6 and 12 weeks
measure: Number of days to first readmission
timeFrame: 24 weeks
measure: Mortality
timeFrame: 24 weeks
Other outcomes:
measure: Physical activity
timeFrame: 12 weeks
measure: Dietary intake
timeFrame: 12 weeks
measure: Technology functionality
timeFrame: 12 weeks
measure: Technology stability
timeFrame: 12 weeks
measure: Technology acceptability
timeFrame: 12 weeks
Locations:
city: Herlev
country: Denmark
facility: Department of Internal Medicine, Copenhagen University Herlev
Study officials:
affiliation: Herlev Hospital
name: Tove L. Damsgaaard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: