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:

1. Patient satisfaction based on a questionnaire
2. Objective parameters (complications, oral hygiene, amount of contacts with department, relapse,...)
3. 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.

Study Overview

• Status: Unknown
• Conditions: Dysgnathia
• Intervention / Treatment: Device: Carey; Other: conventional information

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carey	Device: Carey; mobile application; Other: conventional information; leaflet, internet link and oral information
Active Comparator: conventional information	Device: Carey; mobile application; Other: conventional information; leaflet, internet link and oral information

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Christopher Decoste, Drs, Universitair Ziekenhuis Brussel; Study Chair: Olivier Beckers, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Mobile application; orthognathic surgery; patients satisfaction
• Other Study ID Numbers: Carey v 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No