NCT02703441

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

March 17, 2015

Last Update Submit

September 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lean body-mass

    DEXA scanning,

    Baseline, 6 weeks and 12 weeks

Secondary Outcomes (8)

  • Change in muscle strength

    baseline, 6 and 12 weeks

  • Change in muscle strength

    baseline, 6 and 12 weeks

  • Change in weight

    baseline, 6 and 12 weeks

  • Change in BMI

    baseline, 6 and 12 weeks

  • Change in Health related Quality of Life

    baseline, 6 and 12 weeks

  • +3 more secondary outcomes

Other Outcomes (5)

  • Physical activity

    12 weeks

  • Dietary intake

    12 weeks

  • Technology functionality

    12 weeks

  • +2 more other outcomes

Study Arms (2)

Intervention: Tablet computer

EXPERIMENTAL

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.

Other: Tablet computer

Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Malnutrition and physical activity
Intervention: Tablet computer

Eligibility Criteria

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

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Terminal patients
  • Patients who are not able to communicate or do not understand danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Copenhagen University Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

MalnutritionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tove L. Damsgaaard, Ph.D.

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 9, 2016

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations