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Improving Adherence and Safety of Orthopedic Treatment of Idiopathic Scoliosis in Adolescents Using Information and Communication Technologies

2021年7月26日 更新者:Universitat Jaume I
The present project aims to test the feasibility of a new management mechanism for inter-visit monitoring of adolescent patients with idiopathic scoliosis that improves the quality and safety of current orthopedic treatments using information and communication technologies (ICT).

研究概览

详细说明

Idiopathic scoliosis is defined as a spinal deformity affecting the anteroposterior plane and exceeding 10 degrees of angulation. The label idiopathic arises from ruling out other causes, such as tumors, trauma or infections, that may explain the deformity. This pathology affects approximately 2% of the population, being up to 5 times more frequent in girls than in boys and age playing a fundamental role in the progression and worsening of the problem.

In most cases, scoliosis appears during adolescence (up to 89% of cases according to studies), being very rare up to 3 years of age (between 1% and 5% of detected cases) and slightly more frequent in the infantile stage (7 to 10.5% of scoliosis cases). Scoliosis often does not cause pain or other complications associated with the deformity. However, as the curvature deformity increases (especially after 25 degrees), complications become more pronounced and treatment becomes necessary. For example, in the case of curvatures between 30 and 40 degrees and curves between 20 and 29 degrees that have progressed rapidly in the last year (more than 5 degrees), bracing has become the indicated treatment, while more invasive intervention (surgery) will be necessary in more severe cases.

The prevalence of cases requiring treatment (by bracing or, in the worst case, surgery) is estimated to be between 0.2 and 0.3% of the population under 18 years of age. However, although in many cases scoliosis is not associated with medical complications, it has been shown that, even in people with less severe curvature, this deformity is associated with psychological complications, such as lower self-esteem, a more depressed mood, high alcohol consumption and even suicidal ideation, which are aggravated during treatment.

Through bracing, applied early on, it is hoped that the proper curvature of the spine will be aided by the guidance imposed by the brace. However, although review studies indicate promising results with this intervention, they also indicate that the use of bracing does not yet possess sufficient scientific evidence. This is mainly due, as indicated by the literature, to the low adherence to bracing in this population, which tends to be exaggerated when evaluated retrospectively. Given that one of the best predictors of the effectiveness of orthopedic treatment of scoliosis is, in fact, time in brace use, greater efforts should be made to improve adherence to treatment in this population. Some authors have proposed that factors such as beliefs about the pathology and treatment (e.g., "I don't care about my back" or "I think people will see the brace under my clothes"), as well as the undesirable effects of brace use (e.g., chafing, discomfort when sleeping, or pain), may be at least partly responsible for this low adherence.

With the aforementioned purpose in mind, we hope that the use of our Pain Monitor App, which has been recently validated in an empirical study, will allow early detection of low adherence to brace use, the appearance of undesirable effects of its use or the persistence of dysfunctional beliefs. All this with the aim of acting quickly to promote their adherence to brace use, make changes to the brace when it causes undesirable effects, or perform psychoeducational interventions when dysfunctional beliefs about scoliosis or treatment persist. As a result of the above, we expect to increase the effectiveness of the intervention (better curvature evolution) and the quality of life and emotional well-being of the patients. Avoiding progression of the curvature is important since surgery is associated with significant post-surgical complications, such as infections and mechanical and neurological problems, with low success rate and frequent need for several surgeries, while untreated scoliosis in the adult is often accompanied by chronic low back pain and significant instability.

研究类型

介入性

注册 (预期的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Carlos Suso-Ribera, PhD
  • 电话号码:670421577
  • 邮箱:susor@uji.es

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adolescente patient (between 10 and 18 years old)
  • Wearing a brace for less than 3 months
  • The patient has a mobile phone with Android or iOS operating systems
  • The patients has the physical ability to use the application
  • The patient does not present psychological and or cognitive alterations/ problems with language that make their participation difficult
  • The patient (or the legal tutor) voluntarily wants to participate and sings the informed consent

Exclusion Criteria:

  • The patient does not have an own mobile phone or has a mobile phone with uncompatible characteristics
  • Cognitive alterations, lenguage problems to understand the use of the app and to respond its questions
  • The patient presents a severe mental health issues or substance abuse.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:设备可行性
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:APP+Usual Treatment
Participants at this condition will receive the usual medical treatment for their scoliosis but also they will be monitored daily using the Scoliosis Pain Monitor APP. Alarms will be generated in the face of certain preestablished undesired events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.
Participants at this condition will receive the usual medical treatment for their scoliosis but also they will be monitored daily using the Scoliosis Pain Monitor APP. Alarms will be generated in the face of certain preestablished undesired events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
App' usability will be assessed by the SUS
大体时间:During the app use (one week after app first use)
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higher usability. Total scores are converted into percentages from 0% to 100%.
During the app use (one week after app first use)
App' usability will be assessed by the SUS
大体时间:Immediately after the app use (3 months after app first use)
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
Immediately after the app use (3 months after app first use)
App' acceptability will be assessed by the SUS
大体时间:During the app use (one week after app first use)
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
During the app use (one week after app first use)
App' acceptability will be assessed by the SUS
大体时间:Immediately after the app use (3 months after app first use)
The System Usability Scale will be administered to assess the perception that a tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree"). Half of the items are recorded so that higher scores in the scale represent higer usability. Total scores are converted into percentages from 0% to 100%.
Immediately after the app use (3 months after app first use)
Feasibility of the study will be assessed by a calculation of responses completed
大体时间:Immediately after the app use (3 months after app first use)
Percentage of completed assessments in the app compared to the number of planned evaluations will be calculated
Immediately after the app use (3 months after app first use)

次要结果测量

结果测量
措施说明
大体时间
Stress
大体时间:Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
It will be measured with the Sobberheim Stress Questionnaire (BSSQ brace). It contains 8 items responded based on a 4-points Likert scale (0= "most stress" to 3 = "least stress"). Total scores range from 0 to 24, higher total scores indicating lower stress.
Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Patients' Quality of life
大体时间:Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
It will be measured with the Italian Spine Youth Quality Of Life (ISYQOL). It is composed by 20 items responded by a 3-points Likert scale (0= "never"; 1 = "sometimes"; 2= "often").Total scores are converted into percentages from 0% to 100%, higher percentages indicating greater quality of life.
Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Perceived health status
大体时间:Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
It will be measured with the Scoliosis Research Society -22 (SRS-22). It is composed by 22 items, response rate range from 1= "Severe" to 5= "None". Total score range from 22 to 110, higher scores indicating greater perceived health status.
Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Anxiety and depressive symptoms
大体时间:Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
It will be measured with the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items. Each item is rated according to a 4-point Likert scale from 0= "as much as I always do" to 3 = "not at all". Total scores range between 0 and 21, higher scores represent higher anxiety and depressive symptoms.
Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)
Mood
大体时间:Daily up to 3 months
Questions adapted and validated from the Profile of Mood States and Short Form 12
Daily up to 3 months
Brace adherence
大体时间:Daily up to 3 months
Adherence will be calculated by dividing the number of hours of use reported and the prescription filled
Daily up to 3 months
Treatment safety: Brace-related side effects
大体时间:Daily up to 3 months
An ad hoc question will be created including the most frequent side effects according to the literature and to professionals clinical expertise
Daily up to 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Judith Sánchez-Raya, PhD、Hospitla Universitario Vall d'Hebron
  • 学习椅:Amanda Díaz-García, PhD、Universidad de Zaragoza
  • 学习椅:Diana Castilla, PhD、University of Valencia
  • 学习椅:Verónica Martínez-Borba, MsC、Universitat Jaume I

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月1日

初级完成 (预期的)

2022年6月30日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2021年4月7日

首先提交符合 QC 标准的

2021年5月5日

首次发布 (实际的)

2021年5月11日

研究记录更新

最后更新发布 (实际的)

2021年8月2日

上次提交的符合 QC 标准的更新

2021年7月26日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Only Dra. Sánchez-Raya will be able to access to individual participant data.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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