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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 主要终点
- Toothbrushing duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Toothbrushing duration
时间窗: End of treatment (24-36 months on average)
Timed toothbrush use will be determined via the information stored on the App. It is anticipated that participants will not remember to time each brushing episode, therefore, the duration and number of brushing sessions stored within the App will allow for the average brushing duration to be determined. The unit of measurement will be seconds.
Bleeding score
时间窗: End of treatment (24-36 months on average)
A periodontal probe will be utilised, the presence of bleeding within 10 to 30 seconds of probing is indicative of inflammation of the gingivae. Scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) and will be recorded as the percentage of the total number of tooth surfaces (6 aspects per tooth). A binary score will be assigned to each surface (1 bleeding present, 0 no bleeding).
次要结局
- Plaque score(Base line (start of treatment), 3 months, 12 months, and at the end of treatment (24-36 months on average))
- Number of breakages(3 months, 12 months, and at the end of treatment (24-36 months on average))
- Treatment duration(At the end of treatment (24-36 months on average))
- Enamel demineralisation on the front 6 teeth using standardised photographs(Base line (start of treatment) and at the end of treatment (24-36 months on average))
- Number of missed appointments(3 months, 12 months, and at the end of treatment (24-36 months on average))
- Total number of appointments(At the end of treatment (24-36 months on average))
- App subjective quality(3 months and at the end of treatment (24-36 months on average))
- App engagement (pages accessed and whether this changes with time)(3 months, 12 months, and at the end of treatment (24-36 months on average))