Quality and Effectiveness of a Personalised App to Support Patients With Fixed Braces

NCT ID: NCT04184739

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2025-10-31

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.

Conditions

Treatment Adherence and Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

My Braces App

Intervention Type: OTHER

An App designed to support patients undertaking orthodontic treatment.

Group B

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

Group Type: EXPERIMENTAL

My Braces App

Intervention Type: OTHER

An App designed to support patients undertaking orthodontic treatment.

Group C

As for group B, however, the patients will have access to the full functionality of the 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.

Group Type: EXPERIMENTAL

My Braces App

Intervention Type: OTHER

An App designed to support patients undertaking orthodontic treatment.

Interventions

My Braces App

An App designed to support patients undertaking orthodontic treatment.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan J Cunningham, PhD

Role: PRINCIPAL_INVESTIGATOR

UCL Professor

Central Contacts

Susan J Cunningham, PhD

Role: CONTACT

s.cunningham@ucl.ac.uk

02034561064

Mohammad O Sharif, MSc

Role: CONTACT

mohammad.sharif.16@ucl.ac.uk

References

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.

Reference Type: DERIVED

PMID: 33439142 (View on PubMed)

Other Identifiers

124581

Identifier Type: -

Identifier Source: org_study_id