Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Intervention of Diet Registration Method for Rehabilitation Patients

2. november 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

17

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: 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.

Andre navn:
  • Dietary registration app supplied by Movesca ApS, used on cellphones present at the unit
Annen: 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.
Andre navn:
  • Paper form with all the possbible dietary options for each meal listed.
Aktiv komparator: 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.
Annen: 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.

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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Are the forms used for dietary registration filled out uniformly, by different personale
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Copenhagen

Samarbeidspartnere

Movesca ApS
Departmen for rehabilitation M3, Hobro Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. februar 2021

Primær fullføring (Faktiske)

15. mars 2021

Studiet fullført (Faktiske)

1. juli 2021

Datoer for studieregistrering

Først innsendt

25. januar 2021

Først innsendt som oppfylte QC-kriteriene

1. februar 2021

Først lagt ut (Faktiske)

4. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2022

Sist bekreftet

1. november 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • AppHobro

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Digital Clinical Diet Registrations Advantages

Kliniske studier på Digital dietary registration

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Chile

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere