DysgnathiaNCT03918941
Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery
A study testing Carey and conventional information in people with Dysgnathia, run by Universitair Ziekenhuis Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Dysgnathia
- What is being tested?
- Carey and conventional information
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing orthognathic surgery
- Patients must be able to handle a smartphone.
Who cannot join
- Patients without smartphone
- Patients who have been submitted to orthognathic surgery in the past
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Dysgnathia
- Being tested
- Carey, conventional information
- Keywords
- patients satisfaction, Mobile application, orthognathic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareyDevice
mobile application
conventional informationOther
leaflet, internet link and oral information
| Study group | Role | What they receive |
|---|---|---|
| Carey | Experimental | Not described Receives: Device: Carey; Other: conventional information |
| conventional information | Active comparator | Not described Receives: Device: Carey; Other: conventional information |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Evaluation of patient satisfaction after surgery by means of a survey "Carey v1.0"
Measured: At week 6
Secondary outcomes (4)
Oral hygiene
By means of DPSI (Dutch periodontal screening index)
Measured: At week 6 and 3 months postoperative
Pain control
By means of VAS (visual analogue scale: 0 no pain -10 pain)
Measured: At week 1 and week 3 postoperative
Weight loss
Evaluation of patient weight in kilograms
Measured: the first 3 months postoperative
Maximal mouth opening
Interincisal distance with a measuring rod in centimeters
Measured: At week 6 and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysgnathiaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Christopher Decoste, Drs, Principal investigator, Universitair Ziekenhuis BrusselOlivier Beckers, MD, Study chair, Universitair Ziekenhuis BrusselMaurice Mommaerts, Prof. Mult, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918941
- Sponsor's protocol ID
- Carey v 1.0
- Status last verified
- Aug 2019
- First submitted
- 11 Jan 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03918941
- Acronym / sponsor ID
- Carey v 1.0
- Conditions
- Dysgnathia
- Keywords
- patients satisfaction, Mobile application, orthognathic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Carey | Experimental | Device: Carey, Other: conventional information |
| conventional information | Active comparator | Device: Carey, Other: conventional information |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients undergoing orthognathic surgery
- Patients must be able to handle a smartphone.
Key exclusion criteria (2 listed)
- Patients without smartphone
- Patients who have been submitted to orthognathic surgery in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Careymobile application | Device | Carey, conventional information |
| conventional informationleaflet, internet link and oral information | Other | Carey, conventional information |
Primary outcome
patient satisfaction
Time frame: At week 6
Evaluation of patient satisfaction after surgery by means of a survey "Carey v1.0"
4 secondary outcomes
Oral hygiene
Time frame: At week 6 and 3 months postoperative
Pain control
Time frame: At week 1 and week 3 postoperative
Weight loss
Time frame: the first 3 months postoperative
Maximal mouth opening
Time frame: At week 6 and 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Decoste, Drs principal investigator
Universitair Ziekenhuis Brussel
Olivier Beckers, MD study chair
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof. Mult study director
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Carey and conventional information in people with Dysgnathia, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Mossevelde, Data Nurse (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: At week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.