- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02703441
FoodnGo-Empower: A Feasibility Study of Physical Activities and Nutrition of Older Patients by the Use of Technology
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
Conditions
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:
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Herlev, Denmark, 2730
- Department of Internal Medicine, Copenhagen University Herlev
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in lean body-mass
Time Frame: Baseline, 6 weeks and 12 weeks
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DEXA scanning,
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Baseline, 6 weeks and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in muscle strength
Time Frame: baseline, 6 and 12 weeks
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handgrip strength
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baseline, 6 and 12 weeks
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Change in muscle strength
Time Frame: baseline, 6 and 12 weeks
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chair-stand-test
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baseline, 6 and 12 weeks
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Change in weight
Time Frame: baseline, 6 and 12 weeks
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baseline, 6 and 12 weeks
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Change in BMI
Time Frame: baseline, 6 and 12 weeks
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baseline, 6 and 12 weeks
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Change in Health related Quality of Life
Time Frame: baseline, 6 and 12 weeks
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EQ5D (European Quality 5Dimensions Scale)
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baseline, 6 and 12 weeks
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Change in signs of depression
Time Frame: Baseline, 6 and 12 weeks
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Geriatric Depression Scale 5 (GDS5)
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Baseline, 6 and 12 weeks
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Number of days to first readmission
Time Frame: 24 weeks
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Danish National Patient Register
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24 weeks
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Mortality
Time Frame: 24 weeks
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Danish National Patient Register
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24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical activity
Time Frame: 12 weeks
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Registered by the patient at the computer
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12 weeks
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Dietary intake
Time Frame: 12 weeks
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Registered by the patient at the computer
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12 weeks
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Technology functionality
Time Frame: 12 weeks
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Research assistant observes and registers problems
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12 weeks
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Technology stability
Time Frame: 12 weeks
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Research assistant observes and registers problems
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12 weeks
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Technology acceptability
Time Frame: 12 weeks
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Qualitative interviews with patients and relatives
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12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tove L. Damsgaaard, Ph.D., Herlev Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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