NCT02268721

Brief Summary

The research and Innovation program Food'n'Go - Empower aims to develop, test and implement a health technology solution for involvement and increased empowerment of elderly patients and their relatives. The focus is on frequent issues for this group of patients, in the first phase focusing on nutrition and physical activity. Later, the solution will include pain management, management of sleep problems, management of medication, 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. The program received in the summer of 2013 one of the Capital Region OPI funding for design and development of the prototype, which is now ready and looking very promising. The next step is a pilot feasibility study testing the usability and acceptability as well as effect during hospitalisation and at home after discharge. The present study - Food'to'Go investigates the intervention in the post-discharge period. Aim The overall aim of Food'n'Go research- an innovation programme is to develop, test and implement innovative information technology solutions to increase participation and empowerment of older patients and their families, in relation to frequent problems during hospitalisation and the time after. The aim for the substudy Food'to'Go is to test the feasibility and efficacy of ICT-supported energy- and protein-enforced home-delivered main and in-between meals on older patients, discharged from acute hospitalisation in medical wards. Hereunder:

  • Test the technology's relevance, suitability, acceptability and ease of use in relation to the target group
  • Test the communication loop between patient and kitchen, and relatives external access to the related website Welfare and health technologies are often directed at solving problems and meeting the needs of society's most vulnerable groups, often not familiar with computers. We will, in addition to developing the technological solution, examine user-related barriers and preferences for health technology and try to find solutions that can increase older people's possibilities for using technology and achieve empowerment. The program incorporates research and innovation in an iterative process where research provides answers and solutions to the issues arising in relation to the development of the technology (innovation) and the use of it.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

August 20, 2014

Last Update Submit

March 3, 2016

Conditions

Keywords

Pilot studyFrail elderlyMalnutritionFunctionalityLife qualityHealth care technology

Outcome Measures

Primary Outcomes (1)

  • The technology acceptability and ease of use in relation to the target group

    Method: Registration of how many participants used the technology, as well as registration of the number of problems caused by the technology not working or the participants in-ability to use it. Interviews with patients

    12 weeks

Secondary Outcomes (3)

  • Test of the communication loop between patient and kitchen

    12 weeks

  • Nutritional status

    12 weeks

  • Functional levet

    12 weeks

Study Arms (2)

Controle Group

NO INTERVENTION

Patients in the control group are undergoing the same measurements and records before discharge, and at six and twelve weeks, as the intervention group. The control group receives no special treatment or care after discharge.

App for food delivery

OTHER

Intervention: Tablet Computer Patients in the intervention group receives a tablet upon discharge from the hospital. The tablet contains an app, which the patients in the intervention group can use for ordering meals for delivery from the kitchen at the hospital three times a week. The app also ask the patients to register their own dietary intake, and give them feedback on their daily energy and protein intake. Baseline measurements and records are taken at prior to discharge from the hospital, and after six and twelve weeks.

Device: Tablet computer

Interventions

Patients receive a tablet computer upon discharge. The tablet can be used for ordering food for delivery three times a week from the hospital kitchen.

App for food delivery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • are 65 years or older
  • are admitted to department of internal medicine, O
  • have a nutritional risc score of 3 or more
  • are discharged to own home
  • are able to participate in the project for 12 weeks
  • are able to read, write and understand Danish
  • live within a radius of 20 km radius from Herlev Hospital

You may not qualify if:

  • have food allergies or intolerance
  • are vegetarians
  • are terminally ill
  • are included in the RiSK project
  • are unable to communicate and co-operate on the use of the tablet computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Links

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Tove L Damsgaard, Dr.Med.Sc.

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

August 20, 2014

First Posted

October 20, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations