Intervention of Diet Registration Method for Rehabilitation Patients

NCT ID: NCT04738682

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-07-01

Brief 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.

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.

Conditions

Digital Clinical Diet Registrations Advantages; Patients in Rehabilitation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Digital dietary registration

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Digital dietary registration

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Dietary registration app supplied by Movesca ApS, used on cellphones present at the unit; Paper form with all the possbible dietary options for each meal listed.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Movesca ApS

UNKNOWN

Sponsor Role: collaborator

Departmen for rehabilitation M3, Hobro Hospital

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolaj Nørlem, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Ted Rasmussen, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Department for rehabilitation medicine M3

Hobro, , Denmark

Countries

Denmark

Other Identifiers

AppHobro

Identifier Type: -

Identifier Source: org_study_id