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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04738682
Other study ID # AppHobro
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date July 1, 2021

Study information

Verified date November 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 1, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Digital Clinical Diet Registrations Advantages

Intervention

Other:
Digital dietary registration
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.
Conventional dietary registration
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.

Locations

Country Name City State
Denmark Department for rehabilitation medicine M3 Hobro

Sponsors (3)

Lead Sponsor Collaborator
University of Copenhagen Departmen for rehabilitation M3, Hobro Hospital, Movesca ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Are the forms used for dietary registration filled out uniformly, by different personale 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. 4 weeks
Other Subjective experience of the staff regarding the intervention, examined by doing a semistructured interview with the personale. 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. 4 weeks
Primary Registered total kJ ingested compared to total kJ registered using golden standard Does digital dietary registration yield greater precision than conventional paper based registration, in regards to total kJ? 4 weeks
Primary Registered total protein ingested compared to total protein registered using golden standard Does digital dietary registration yield greater precision than conventional paper based registration, in regards to protein intake? 4 weeks
Secondary Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration 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 4 weeks
Secondary Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration 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 4 weeks