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评估一款个性化手机应用程序在提高正畸患者口腔卫生建议依从性方面的有效性和可接受性:可行性研究和随机对照试验方案

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.

作者信息

Sharif Mohammad Owaise, Newton Jonathon Timothy, Cunningham Susan J

机构信息

Eastman Dental Institute, University College London, London, United Kingdom.

King's College London, London, United Kingdom.

出版信息

JMIR Res Protoc. 2021 Jan 13;10(1):e18021. doi: 10.2196/18021.

DOI:10.2196/18021
PMID:33439142
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7840283/
Abstract

BACKGROUND

Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore 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 noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual's capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual's capability, opportunity, and motivation.

OBJECTIVE

This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial.

METHODS

This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app.

RESULTS

This study was approved by the London - Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020.

CONCLUSIONS

Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18021.

摘要

背景

正畸治疗是一种常见的医疗保健干预措施;治疗周期可能较长(平均2 - 3年),因此遵循治疗建议对于取得成功的治疗效果至关重要。据报道,高达43%的患者未能完成治疗,目前尚无有效的未完成治疗的预测指标。鉴于英国国家医疗服务体系每年在初级保健正畸治疗上的支出超过2亿英镑(2.67亿美元),治疗未完成意味着公共资源的严重低效利用。因此,提高对治疗的依从性至关重要。这需要行为改变,而旨在提高依从性并引发行为改变的干预措施必须解决个体的能力、机会和动机问题。在这方面,手机可能是一种非常宝贵的工具,因为它们随时可用,并且可以通过多种方式来解决个体的能力、机会和动机问题。

目的

本研究将通过一项随机对照试验评估一款个性化手机应用程序在提高对正畸治疗建议的依从性方面的有效性和可接受性。

方法

本研究将在伦敦大学学院医院基金会信托旗下的伊斯特曼牙科医院分两个阶段进行。第一阶段是对“我的牙套”应用程序进行可行性测试。将要求参与者完成移动应用程序评分量表的用户版。如有必要,将在对回复进行分析后对应用程序进行修改。第二阶段是一项随机对照试验,以测试“我的牙套”应用程序的有效性和可接受性。

结果

本研究于2019年11月5日获得伦敦 - 布鲁姆斯伯里研究伦理委员会批准(参考编号19/LO/1555)。截至目前尚未招募患者。预计第一阶段的招募开始日期为2020年10月。

结论

鉴于手机的可用性、可承受性和多功能性,建议手机将有助于提高对治疗建议的依从性,从而提高治疗完成率。如果有效,这种方法在开发行为改变/修正干预措施以及提高整个医疗保健领域对治疗的依从性方面的适用性将提供一个令人兴奋的机会。

试验注册

ClinicalTrials.gov NCT04184739;https://clinicaltrials.gov/ct2/show/NCT04184739。

国际注册报告识别码(IRRID):PRR1-10.2196/18021。

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