- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04738682
Intervention of Diet Registration Method for Rehabilitation Patients
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Hobro, Danmark, 9500
- Department for rehabilitation medicine M3
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
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 navne:
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 navne:
|
|
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.
|
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 navne:
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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nicolaj Nørlem, MSc, University of Copenhagen
- Ledende efterforsker: Ted Rasmussen, MSc, University of Copenhagen
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- AppHobro
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Digital dietary registration
-
University of PrimorskaCommunity Healthcare Center dr. Adolf Drolc Maribor (HCM)Aktiv, ikke rekrutterende
-
Universidad de GranadaRekruttering
-
Nanjing Medical UniversityTilmelding efter invitationMavekræft (GC) | Skrøbelighed i voksenkirurgiKina
-
The Hong Kong Polytechnic UniversityAktiv, ikke rekrutterendeSarkopenisk fedmeHong Kong
-
University of ThessalyRekrutteringMultipel sclerose | Anæmi | IBD | Colitis Ulcerativ | Hypertension (HTN)Grækenland
-
NeuroEnergy Ventures, Inc.Aktiv, ikke rekrutterende
-
University of VermontAfsluttet
-
King's College LondonGuy's HospitalAfsluttetTemporomandibulære lidelser (TMD)Det Forenede Kongerige
-
Cairo Universitymai albanaRekrutteringTidsstyring | Problematisk brug af smartphone | Digital DistraktionSaudi Arabien
-
South London and Maudsley NHS Foundation TrustUkendtFørste episode psykoseDet Forenede Kongerige