- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738682
Intervention of Diet Registration Method for Rehabilitation Patients
Audit and Intervention of Diet Registration Method for Rehabilitation Patients at Hobro Hospital
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
Study intervention is based in the M3 rehabilitation unit, as part of Hobro hospital. The intervention will proceed until 6 full-day dietary registrations have been collected per patient (40 patients total), 3 for each registration method. The estimated time requirement is 30 days.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
These mobile devices have been equipped with a dietary registration app, developed by the company Movesca ApS, specializing in digital healthcare solutions.
Nurses, and other relevant staff members at the M3 rehabilitation unit at Hobro hospital, will be testing this alternative registration method, as they engage in their day-to-day dietary registration for in-house patients. The data collection requires 6 full-day dietary registrations from each individual patient (40 patients in total). Of these 6 registrations, 3 will be gathered using mobile devices and 3 using conventional paper based registers.
The study primary endpoint is precision. The golden standard is dietary recall. The two methods will be assessed in accordance with their uniformity to the dietary recalls, which will be performed by the investigators following the meals.
As a preemptive measure, an internal retrospective audit was performed, with dietary registration as the objective. This audit was completed to retrieve baseline data on dietary registration, and determine whether the rehabilitation unit conforms to the regulations set by the region.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hobro, Denmark, 9500
- Department for rehabilitation medicine M3
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient needs to be admitted to the rehabilitation unit at Hobro Hospital
- The patient need to give consent to be included.
- The patient needs to be admitted to the unit for at least 6 days
- The patient has to have 3 days of diet registration with both methods to be included in the data
- The patient need to be of legal age to give consent
Exclusion Criteria:
- The patient mustn be afflicted by any psychological illness, and must be of sound mind, so a normal conversation doesn't pose any problems.
- The patient mustn be sick with Covid-19, or other infectious diseases
- The patient mustn be terminal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group 1 (Digital -> Conventional)
Patients allocated to Group 1 (Digital -> Conventional) will undergo three days of digital dietary registration, using mobile devices, followed by three days of conventional dietary registration, using pen and paper.
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The purpose of the intervention is to test whether digital dietary registration can yield more precise and consistent data, than conventional pen and paper based registration. Furthermore a subjective evaluation of the use of digital registration will be conducted by the staff upon completion of the intervention. The format will be individual interviews held by the investigators.
Other Names:
The conventional way of doing dietary registration.
This is done by a paper form, with the dietary options listed.
The form is then filled in and logged by staff working in the afternoon.
Other Names:
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Active Comparator: Group 2 - (Conventional -> Digital)
Patients allocated to Group 2 - (Conventional -> Digital) will undergo the exact opposite sequence, commencing with three days of conventional dietary registration, using pen and paper, followed by three days of digital dietary registration, using mobile devices.
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The purpose of the intervention is to test whether digital dietary registration can yield more precise and consistent data, than conventional pen and paper based registration. Furthermore a subjective evaluation of the use of digital registration will be conducted by the staff upon completion of the intervention. The format will be individual interviews held by the investigators.
Other Names:
The conventional way of doing dietary registration.
This is done by a paper form, with the dietary options listed.
The form is then filled in and logged by staff working in the afternoon.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Registered total kJ ingested compared to total kJ registered using golden standard
Time Frame: 4 weeks
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Does digital dietary registration yield greater precision than conventional paper based registration, in regards to total kJ?
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4 weeks
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Registered total protein ingested compared to total protein registered using golden standard
Time Frame: 4 weeks
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Does digital dietary registration yield greater precision than conventional paper based registration, in regards to protein intake?
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Time Frame: 4 weeks
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Do patients reach a stable nutritional state faster when exposed to digital dietary registration, compared to conventional paper based registration?
Stable nutritional state is defined as consuming >75% of estimated kJ need per day.
Tracked by comparing the registered consumed kJ of the day, with the estimated daily need
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4 weeks
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Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Time Frame: 4 weeks
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Do patients reach a stable nutritional state faster when exposed to digital dietary registration, compared to conventional paper based registration?
Stable nutritional state is defined as consuming >75% of estimated protein need per day.
Tracked by comparing the registered consumed protein of the day, with the estimated daily need
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Are the forms used for dietary registration filled out uniformly, by different personale
Time Frame: 4 weeks
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It will be examined whether or not the personal fills out the forms uniformly across all the included personale.
It will be examined by comparing dietary registrations from different days, filled out by different personale.
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4 weeks
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Subjective experience of the staff regarding the intervention, examined by doing a semistructured interview with the personale.
Time Frame: 4 weeks
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Do staff consider digital dietary registration to be an improvement over conventional paper based registration?
This will be explored by semistructured interview, held by the investigators.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolaj Nørlem, MSc, University of Copenhagen
- Principal Investigator: Ted Rasmussen, MSc, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AppHobro
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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