- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Carey
|
mobile application
leaflet, internet link and oral information
|
|
Comparateur actif: conventional information
|
mobile application
leaflet, internet link and oral information
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
patient satisfaction
Délai: At week 6
|
Evaluation of patient satisfaction after surgery by means of a survey "Carey v1.0"
|
At week 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oral hygiene
Délai: At week 6 and 3 months postoperative
|
By means of DPSI (Dutch periodontal screening index)
|
At week 6 and 3 months postoperative
|
|
Pain control
Délai: 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
Délai: the first 3 months postoperative
|
Evaluation of patient weight in kilograms
|
the first 3 months postoperative
|
|
Maximal mouth opening
Délai: At week 6 and 3 months postoperative
|
Interincisal distance with a measuring rod in centimeters
|
At week 6 and 3 months postoperative
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christopher Decoste, Drs, Universitair Ziekenhuis Brussel
- Chaise d'étude: Olivier Beckers, MD, Universitair Ziekenhuis Brussel
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Carey v 1.0
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .