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

Primary Purpose

Malnutrition, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tablet computer
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Copenhagen University Herlev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Tablet computer

Control group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in lean body-mass
DEXA scanning,

Secondary Outcome Measures

Change in muscle strength
handgrip strength
Change in muscle strength
chair-stand-test
Change in weight
Change in BMI
Change in Health related Quality of Life
EQ5D (European Quality 5Dimensions Scale)
Change in signs of depression
Geriatric Depression Scale 5 (GDS5)
Number of days to first readmission
Danish National Patient Register
Mortality
Danish National Patient Register

Full Information

First Posted
March 17, 2015
Last Updated
September 29, 2016
Sponsor
Herlev Hospital
Collaborators
Tachista
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1. Study Identification

Unique Protocol Identification Number
NCT02703441
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Tachista

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Tablet computer
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tablet computer
Other Intervention Name(s)
Malnutrition and physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in lean body-mass
Description
DEXA scanning,
Time Frame
Baseline, 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
handgrip strength
Time Frame
baseline, 6 and 12 weeks
Title
Change in muscle strength
Description
chair-stand-test
Time Frame
baseline, 6 and 12 weeks
Title
Change in weight
Time Frame
baseline, 6 and 12 weeks
Title
Change in BMI
Time Frame
baseline, 6 and 12 weeks
Title
Change in Health related Quality of Life
Description
EQ5D (European Quality 5Dimensions Scale)
Time Frame
baseline, 6 and 12 weeks
Title
Change in signs of depression
Description
Geriatric Depression Scale 5 (GDS5)
Time Frame
Baseline, 6 and 12 weeks
Title
Number of days to first readmission
Description
Danish National Patient Register
Time Frame
24 weeks
Title
Mortality
Description
Danish National Patient Register
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Physical activity
Description
Registered by the patient at the computer
Time Frame
12 weeks
Title
Dietary intake
Description
Registered by the patient at the computer
Time Frame
12 weeks
Title
Technology functionality
Description
Research assistant observes and registers problems
Time Frame
12 weeks
Title
Technology stability
Description
Research assistant observes and registers problems
Time Frame
12 weeks
Title
Technology acceptability
Description
Qualitative interviews with patients and relatives
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tove L. Damsgaaard, Ph.D.
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Copenhagen University Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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

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