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

Physical Activity Clinical Trial

Official title:

FoodnGo - Empower: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703441
• Other study ID #: H-O-FNG-2015-1
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: September 29, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition
• Physical Activity

Intervention

Other:
• Tablet computer
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.

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine, Copenhagen University Herlev	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Tachista

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Registered by the patient at the computer	12 weeks	No
Other	Dietary intake	Registered by the patient at the computer	12 weeks	No
Other	Technology functionality	Research assistant observes and registers problems	12 weeks	No
Other	Technology stability	Research assistant observes and registers problems	12 weeks	No
Other	Technology acceptability	Qualitative interviews with patients and relatives	12 weeks	No
Primary	Change in lean body-mass	DEXA scanning,	Baseline, 6 weeks and 12 weeks	No
Secondary	Change in muscle strength	handgrip strength	baseline, 6 and 12 weeks	No
Secondary	Change in muscle strength	chair-stand-test	baseline, 6 and 12 weeks	No
Secondary	Change in weight		baseline, 6 and 12 weeks	No
Secondary	Change in BMI		baseline, 6 and 12 weeks	No
Secondary	Change in Health related Quality of Life	EQ5D (European Quality 5Dimensions Scale)	baseline, 6 and 12 weeks	No
Secondary	Change in signs of depression	Geriatric Depression Scale 5 (GDS5)	Baseline, 6 and 12 weeks	No
Secondary	Number of days to first readmission	Danish National Patient Register	24 weeks	No
Secondary	Mortality	Danish National Patient Register	24 weeks	No