MalnutritionNCT02268721
Food'to'Go - a Feasibility Study of Post-discharge Meals for Older Patients by the Use of ICT-technology
A study testing Tablet computer in people with Malnutrition, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Tablet computer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food'to'Go - a Feasibility Study of Post-discharge Delivery of Protein- and Energy-enforced Meals for Older Patients by the Use of ICT-technology
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.
Read more
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.
- Conditions
- Malnutrition
- Being tested
- Tablet computer
- Keywords
- Pilot study, Frail elderly, Malnutrition, Functionality, Life quality, Health care technology
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet computerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tablet computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
Test of the communication loop between patient and kitchen
Registration of the number of problems caused by lack of communication between devices, or between staff and participants.
Measured: 12 weeks
Nutritional status
BMI and weight
Measured: 12 weeks
Functional levet
Hand-grip strength and chair-stand-test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tachista
- Responsible party
- Principal investigator, Tove Lindhardt Damsgaard, Herlev Hospital
- Investigators
- Tove L Damsgaard, Dr.Med.Sc., Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268721
- Sponsor's protocol ID
- H-O-FNG-2014-1
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2014
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food'to'Go - a Feasibility Study of Post-discharge Delivery of Protein- and Energy-enforced Meals for Older Patients by the Use of ICT-technology
- ClinicalTrials.gov ID
- NCT02268721
- Acronym / sponsor ID
- H-O-FNG-2014-1
- Conditions
- Malnutrition
- Keywords
- Pilot study, Frail elderly, Malnutrition, Functionality, Life quality, Health care technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Tachista
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Tablet computerIntervention: 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet computerPatients receive a tablet computer upon discharge. The tablet can be used for ordering food for delivery three times a week from the hospital kitchen. | Device | App for food delivery |
Primary outcome
The technology acceptability and ease of use in relation to the target group
Time frame: 12 weeks
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
3 secondary outcomes
Test of the communication loop between patient and kitchen
Time frame: 12 weeks
Nutritional status
Time frame: 12 weeks
Functional levet
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Capital region of Denmark's introduction to the project behind the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tove L Damsgaard, Dr.Med.Sc. principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet computer in people with Malnutrition, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The technology acceptability and ease of use in relation to the target group (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.