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Intervention of Diet Registration Method for Rehabilitation Patients

2. November 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

17

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Sonstiges: 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
Sonstiges: 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.
Aktiver 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.
Sonstiges: 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
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Are the forms used for dietary registration filled out uniformly, by different personale
Zeitfenster: 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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Copenhagen

Mitarbeiter

Movesca ApS
Departmen for rehabilitation M3, Hobro Hospital

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Februar 2021

Primärer Abschluss (Tatsächlich)

15. März 2021

Studienabschluss (Tatsächlich)

1. Juli 2021

Studienanmeldedaten

Zuerst eingereicht

25. Januar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Februar 2021

Zuerst gepostet (Tatsächlich)

4. Februar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2022

Zuletzt verifiziert

1. November 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • AppHobro

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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