Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dysgnathia

Intervention / Treatment
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* Device: Carey
* Other: conventional information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group 1 will use the mobile application (Carey) throughout their pre- and postoperative journey group 2 will follow the conventional pre- and postoperative care sequence (control group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carey<br> | Device: Carey<br>* mobile application<br>Other: conventional information<br>* leaflet, internet link and oral information<br>|
| Active Comparator: conventional information<br> | Device: Carey<br>* mobile application<br>Other: conventional information<br>* leaflet, internet link and oral information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | Evaluation of patient satisfaction after surgery by means of a survey Carey v1.0 | At week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral hygiene | By means of DPSI (Dutch periodontal screening index) | At week 6 and 3 months postoperative | 
| Pain control | By means of VAS (visual analogue scale: 0 no pain -10 pain) | At week 1 and week 3 postoperative | 
| Weight loss | Evaluation of patient weight in kilograms | the first 3 months postoperative | 
| Maximal mouth opening | Interincisal distance with a measuring rod in centimeters | At week 6 and 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients satisfaction, Mobile application, orthognathic surgery