- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03918941
Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery
Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery: a Multi-center Prospective Single Blind Randomized Clinical Trial About Patietn Information and Patient Satisfaction
Carey is a mobile application guiding patients throughout their orthognathic surgery journey. The purpose of the application is optimizing the patient's experience before, during and after orthognathic surgery improving patient satisfaction and reducing complications. This will be evaluated based on the following outcomes:
- Patient satisfaction based on a questionnaire
- Objective parameters (complications, oral hygiene, amount of contacts with department, relapse,...)
- Patient-reported outcomes (PROM)
The objective of the study is to evaluate whether the use of a mobile coach application in orthognathic surgery can improve patient satisfaction and reduce complications.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Different studies pointed out the importance of patient information prior, during and after orthognathic surgery. It results in better recovery, less postoperative complications and improved patient satisfaction. In other words: a higher health care quality. Insufficient or omitted information about the procedure, surgical complications and/or postoperative care are an important cause of patient dissatisfaction.
Nowadays, patients receive a large amount of explanations, instructions and advices during their admission. Prior to surgery the surgeon will supply information about the procedure, sometimes aided by a website or online videos. Additionally the surgeon informs about the surgical complications, such as postoperative pain, restricted jaw movements, weight loss, swelling, scarring, jaw fixation, absenteeism from work, mood swings, and lip numbness.
The surgeon also supplies information by leaflets, oral and/or written instructions before discharge after surgery. This information however is often bulky, non-specific and incomplete. Furthermore, the surgeon knows that memory for medical information is poor and inaccurate resulting in nescient patients after returning home. For the surgeon it is a challenge to supply the right information at the right time, questioning the effectiveness of this conventional approach.
Some studies already showed that the use of multimedia represents a more effective method for patient education in comparison to the conventional approach. Patients prefer information through videos, interactive and moving images deriving better informed patients.
Furthermore, information provided by other patients was seen an added value. Adequate medication, dietary, oral hygiene and general advice could prevent complications.
Therefore, the use of interactive platforms such as a mobile application with phased information partition (the right information at the right time) could improve patient satisfaction, prevent unplanned consultations and even readmissions.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients undergoing orthognathic surgery
- Patients must be able to handle a smartphone.
Exclusion Criteria:
- Patients without smartphone
- Patients who have been submitted to orthognathic surgery in the past
Studieplan
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 |
|---|---|
|
Eksperimentel: Carey
|
mobile application
leaflet, internet link and oral information
|
|
Aktiv komparator: conventional information
|
mobile application
leaflet, internet link and oral information
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
patient satisfaction
Tidsramme: At week 6
|
Evaluation of patient satisfaction after surgery by means of a survey "Carey v1.0"
|
At week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral hygiene
Tidsramme: At week 6 and 3 months postoperative
|
By means of DPSI (Dutch periodontal screening index)
|
At week 6 and 3 months postoperative
|
|
Pain control
Tidsramme: At week 1 and week 3 postoperative
|
By means of VAS (visual analogue scale: 0 no pain -10 pain)
|
At week 1 and week 3 postoperative
|
|
Weight loss
Tidsramme: the first 3 months postoperative
|
Evaluation of patient weight in kilograms
|
the first 3 months postoperative
|
|
Maximal mouth opening
Tidsramme: At week 6 and 3 months postoperative
|
Interincisal distance with a measuring rod in centimeters
|
At week 6 and 3 months postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christopher Decoste, Drs, Universitair Ziekenhuis Brussel
- Studiestol: Olivier Beckers, MD, Universitair Ziekenhuis Brussel
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- Carey v 1.0
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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