Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery

NCT ID: NCT03918941

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-05-01

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:

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

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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.

Conditions

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Dysgnathia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
The investigator does not know the identity of the patients neither which group uses the app

Study Groups

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Carey

Group Type EXPERIMENTAL

Carey

Intervention Type DEVICE

mobile application

conventional information

Intervention Type OTHER

leaflet, internet link and oral information

conventional information

Group Type ACTIVE_COMPARATOR

Carey

Intervention Type DEVICE

mobile application

conventional information

Intervention Type OTHER

leaflet, internet link and oral information

Interventions

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Carey

mobile application

Intervention Type DEVICE

conventional information

leaflet, internet link and oral information

Intervention Type OTHER

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Decoste, Drs

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Olivier Beckers, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Maurice Mommaerts, Prof. Mult

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Central Contacts

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Veerle Van Mossevelde, Data Nurse

Role: CONTACT

+3224763134

Other Identifiers

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Carey v 1.0

Identifier Type: -

Identifier Source: org_study_id

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