Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Intervention of Diet Registration Method for Rehabilitation Patients

2 november 2022 bijgewerkt door: Jens Rikardt Andersen, University of Copenhagen

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Hobro, Denemarken, 9500
        • Department for rehabilitation medicine M3

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: 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.

Andere namen:
  • Dietary registration app supplied by Movesca ApS, used on cellphones present at the unit
Ander: 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.
Andere namen:
  • Paper form with all the possbible dietary options for each meal listed.
Actieve vergelijker: 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.
Ander: 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.

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Registered total kJ ingested compared to total kJ registered using golden standard
Tijdsspanne: 4 weeks
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to total kJ?
4 weeks
Registered total protein ingested compared to total protein registered using golden standard
Tijdsspanne: 4 weeks
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to protein intake?
4 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Tijdsspanne: 4 weeks
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
Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Tijdsspanne: 4 weeks
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Are the forms used for dietary registration filled out uniformly, by different personale
Tijdsspanne: 4 weeks
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
Subjective experience of the staff regarding the intervention, examined by doing a semistructured interview with the personale.
Tijdsspanne: 4 weeks
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Copenhagen

Medewerkers

Movesca ApS
Departmen for rehabilitation M3, Hobro Hospital

Onderzoekers

  • Hoofdonderzoeker: Nicolaj Nørlem, MSc, University of Copenhagen
  • Hoofdonderzoeker: Ted Rasmussen, MSc, University of Copenhagen

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 februari 2021

Primaire voltooiing (Werkelijk)

15 maart 2021

Studie voltooiing (Werkelijk)

1 juli 2021

Studieregistratiedata

Eerst ingediend

25 januari 2021

Eerst ingediend dat voldeed aan de QC-criteria

1 februari 2021

Eerst geplaatst (Werkelijk)

4 februari 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2022

Laatste update ingediend die voldeed aan QC-criteria

2 november 2022

Laatst geverifieerd

1 november 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • AppHobro

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Digital dietary registration

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Czech Republic

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren