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A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery (RRS)

22. oktober 2012 opdateret af: Martin Vesterby, Regionshospitalet Silkeborg

The Effect of Remote Rehabilitation Support Via a Telemedicine Solution for Patients Undergoing an Optimized Fast-track Orthopedic Surgery Procedure With the Implementation of a Total Hip Arthroplasty.

The RRS project is a Randomized Clinical Trial documenting the effect of Remote Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty. With the telemedicine solution the investigators will support and try to motivate the patient to be discharged after only one day of hospitalization.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This PhD study evaluates the effect of an information technology solution containing RRS. The way it supports, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.

The parameters evaluated will be: Length of stay, health-related quality-of-life (HRQOL), functional outcome, pain, anxiety, complications and an evaluation of the socio-economic effect.

The aim of the study generates the following hypotheses and focus for publication

  • Length of stay is lower for the intervention group compared to the control group.
  • The average quality of life measured with EQ-5D will either be the same or higher when comparing the intervention group with the control group.
  • Compared to the control group the functional outcome of the intervention group measured with Oxford Hip Score (OHS) and Timed Up and Go (TUG) will be the same or better.
  • Complications measured as luxations, infections, and reoperations are the same or lower in the intervention group compared to the control group.
  • There will be a correlation between patients with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG.
  • There will be a correlation between support persons with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG for the patient they are related to.
  • The socio-economic costs will be lower for the intervention group compared to the control group based on self reported data and data collected from official databases. This study will be conducted as a piggy back to the RCT.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Silkeborg, Danmark, 8600
        • Regionshospitalet Silkeborg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.

Exclusion Criteria:

  • Previous hip surgery with the implantation of a total hip arthroplasty.
  • Patients living more than approximately 60 kilometers from the Regionshospitalet Silkeborg.
  • Patients with no 3G tele-net at their home address.
  • Patients with the need of Danish interpretation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Telemedicine
RRS via telemedicine. By developing the concept of Remote Rehabilitation Support (RRS) the investigators will try to bring preoperative education of the patient, dissemination of information and postoperative support to a new level.
Procedure: remote rehabilitation support
An information technology solution containing RRS. The way it supports,, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.
Andre navne:
  • Rehabilitering
  • Fast-track
Ingen indgriben: Standard
The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EQ5D
Tidsramme: 12 måneder
12 måneder
LOS
Tidsramme: up to 5 days
Length of Stay
up to 5 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SCL-90-r
Tidsramme: day 0
psychological problems and symptoms of psychopathology
day 0
TUG
Tidsramme: day 90
Time up and go
day 90
anxiety
Tidsramme: Day 90
VAS - anxiety
Day 90

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regionshospitalet Silkeborg

Samarbejdspartnere

Lundbeck Foundation
Caretech Innovation

Efterforskere

  • Studieleder: Kjeld Soballe, Professor, University of Aarhus, Orthopaedic surgical research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2009

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

28. august 2009

Først indsendt, der opfyldte QC-kriterier

28. august 2009

Først opslået (Skøn)

31. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2009-RSI-RRS

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 Livskvalitet

Kliniske forsøg med remote rehabilitation support

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

CROs in Burundi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner