Physical Activity Clinical Trial
Official title:
FoodnGo - Empower: A Feasibility Study
Verified date | September 2016 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Internal Medicine, Copenhagen University Herlev | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital | Tachista |
Denmark,
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 |
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