Clinical trial NCT04738682: Intervention of Diet Registration Method for Rehabilitation Patients
Official title: Audit and Intervention of Diet Registration Method for Rehabilitation Patients at Hobro Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Clinical Diet Registrations Advantages
Patients in Rehabilitation
Keywords: dietary registration
methods for diet registration
comparison of electronic and paper registration
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Movesca ApS
name: Departmen for rehabilitation M3, Hobro Hospital
First posted: 2021-02-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Modified crossover study model, containing two similar patient groups, exposed to identical diet registration methods, but in opposite sequence.

Group 1: 3 days of digital dietary registration using mobile devices, followed by 3 days of conventional paper based dietary registration.

Group 2: 3 days of conventional paper based dietary registration, followed by 3 days of digital dietary registration, using mobile devices.

Each individual patient acts as his/her own control, with regards to the primary endpoint; precision. However patients are divided into two groups, in order to accommodate the study secondary endpoint; progression of nutritional condition, which is evaluated with regards to the registration method used. This requires two arms, where each arm experiences opposite registration method sequences
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Registered total kJ ingested compared to total kJ registered using golden standard
timeFrame: 4 weeks
measure: Registered total protein ingested compared to total protein registered using golden standard
timeFrame: 4 weeks
Secondary outcomes:
measure: Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
timeFrame: 4 weeks
measure: Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
timeFrame: 4 weeks
Other outcomes:
measure: Are the forms used for dietary registration filled out uniformly, by different personale
timeFrame: 4 weeks
measure: Subjective experience of the staff regarding the intervention, examined by doing a semistructured interview with the personale.
timeFrame: 4 weeks
Locations:
city: Hobro
country: Denmark
facility: Department for rehabilitation medicine M3
Study officials:
affiliation: University of Copenhagen
name: Nicolaj Nørlem, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Ted Rasmussen, MSc
role: PRINCIPAL_INVESTIGATOR
References: