Clinical trial NCT04184739: Quality and Effectiveness of a Personalised App to Support Patients With Fixed Braces
Official title: Investigating the Quality and Effectiveness of a Personalised Mobile App Designed to Support Patients With Fixed (Train Track) Braces: A Randomised Controlled Trial (Student Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment Adherence and Compliance
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 138
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mobile phones are potentially an invaluable tool in improving adherence, they are readily available and can utilised to deliver several approaches to improve adherence simultaneously. A personalised App to help support orthodontic patients ('My Braces') was therefore developed by the researchers. The App provides generic treatment information and also has a personalised element. The personalised element allows patients to input their own treatment information (including progress photographs), set goals, develop plans for achieving these and it provides the patient and clinicians with appropriate dashboards to monitor progress.

This research will be conducted at the Eastman Dental Hospital, UCLH Foundation Trust, London. The aim is to assess the effectiveness of the My Braces App, an App designed to support patients undergoing fixed orthodontic treatment.

Effectiveness of the My Braces App will be tested by way of a randomised controlled trial. Participants will be allocated to one of three groups:

Group A: Standard treatment information (verbal and written) and access to a basic version of the My Braces App with a toothbrushing timer. The timer is necessary as the health behaviour outcome is toothbrushing duration.

Group B: As for group A, however, additionally the My Braces App will provide generic treatment information (a combination of videos and text)

Group C: As for group B, however, the patients will have access to the full functionality of the My Braces App and the App will allow patients to input their own personalised treatment information (including progress photographs), set goals, develop plans for achieving these and provide the patient and clinicians with appropriate dashboards to monitor progress.

Detailed description: The National Child Dental Health Survey (England, Wales and Northern Ireland) indicated that 9% of 12 years olds are receiving orthodontic treatment (the use of braces to straighten teeth) and a further 37% have an unmet need. Treatment duration is lengthy (2-3 years on average) and adherence to treatment advice is essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment and there are currently no useful predictors of non-completion. The NHS England annual spend on primary care orthodontics is in excess of £200 million, non-completion of treatment therefore represents a significant inefficient use of public resources.

Mobile phones are potentially an invaluable tool in improving adherence, they are readily available and can utilised to deliver several approaches to improve adherence simultaneously. A personalised App to help support orthodontic patients ('My Braces') was therefore developed by the researchers. The App provides generic treatment information and also has a personalised element. The personalised element allows patients to input their own treatment information (including progress photographs), set goals, develop plans for achieving these and it provides the patient and clinicians with appropriate dashboards to monitor progress.

This research will be conducted at the Eastman Dental Hospital, UCLH Foundation Trust, London. The aim is to assess the effectiveness of the My Braces App, an App designed to support patients undergoing fixed orthodontic treatment.

Effectiveness of the My Braces App will be tested by way of a randomised controlled trial. Participants will be allocated to one of three groups:

Group A: Standard treatment information (verbal and written) and access to a basic version of the My Braces App with a toothbrushing timer. The timer is necessary as the health behaviour outcome is toothbrushing duration.

Group B: As for group A, however, additionally the My Braces App will provide generic treatment information (a combination of videos and text)

Group C: As for group B, however, the patients will have access to the full functionality of the My Braces App and the App will allow patients to input their own personalised treatment information (including progress photographs), set goals, develop plans for achieving these and provide the patient and clinicians with appropriate dashboards to monitor progress.

It is important to include Group B as this will allow the team to ascertain whether it is the personalisation of the App content which infers any benefit over and above providing generic information via an App if a difference is found between Groups A and C.

Eligibility criteria: Inclusion Criteria:

* Patients accepted for orthodontic treatment utilising fixed orthodontic braces ('train track' braces) at the Eastman Dental Hospital, UCLH Foundation Trust (UCLH EDH)
* 10-18 years (inclusive) at the start of treatment
* Familiarity with, and daily access to, a smartphone/tablet • Ability to read and communicate in English

Exclusion Criteria:

* Craniofacial/Orthognathic patients or those with severe hypodontia (developmental absence of teeth); these patients require complex multi-disciplinary treatment. The information need for these patients is therefore different to routine orthodontic treatment
* Communication difficulties (for example, severe autism, learning difficulties)
* Patients who are aware that a family member/friend is enrolled in the study (including a preceding feasibility study, the pilot or RCT) - this is to avoid the patient potentially having access to parts of the App relating to groups other than that the patient is allocated to

Primary outcomes:
measure: Toothbrushing duration
timeFrame: 3 months
measure: Toothbrushing duration
timeFrame: 12 months
measure: Toothbrushing duration
timeFrame: End of treatment (24-36 months on average)
measure: Bleeding score
timeFrame: Base line (start of treatment)
measure: Bleeding score
timeFrame: 3 months
measure: Bleeding score
timeFrame: 12 months
measure: Bleeding score
timeFrame: End of treatment (24-36 months on average)
Secondary outcomes:
measure: Plaque score
timeFrame: Base line (start of treatment), 3 months, 12 months, and at the end of treatment (24-36 months on average)
measure: Number of breakages
timeFrame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
measure: Number of missed appointments
timeFrame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
measure: Total number of appointments
timeFrame: At the end of treatment (24-36 months on average)
measure: Treatment duration
timeFrame: At the end of treatment (24-36 months on average)
measure: Enamel demineralisation on the front 6 teeth using standardised photographs
timeFrame: Base line (start of treatment) and at the end of treatment (24-36 months on average)
measure: App subjective quality
timeFrame: 3 months and at the end of treatment (24-36 months on average)
measure: App engagement (pages accessed and whether this changes with time)
timeFrame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Other outcomes:
Locations:
Study officials:
affiliation: UCL Professor
name: Susan J Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharif MO, Newton JT, Cunningham SJ. Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 13;10(1):e18021. doi: 10.2196/18021.