Clinical trial NCT03918941: Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysgnathia
Keywords: patients satisfaction
Mobile application
orthognathic surgery
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient satisfaction
timeFrame: At week 6
Secondary outcomes:
measure: Oral hygiene
timeFrame: At week 6 and 3 months postoperative
measure: Pain control
timeFrame: At week 1 and week 3 postoperative
measure: Weight loss
timeFrame: the first 3 months postoperative
measure: Maximal mouth opening
timeFrame: At week 6 and 3 months postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Christopher Decoste, Drs
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Olivier Beckers, MD
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof. Mult
role: STUDY_DIRECTOR
References: