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

2021년 7월 26일 업데이트: 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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

10

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Carlos Suso-Ribera, PhD
  • 전화번호: 670421577
  • 이메일: susor@uji.es

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

10년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 장치 타당성
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
App' usability will be assessed by the SUS
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Stress
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 6월 1일

기본 완료 (예상)

2022년 6월 30일

연구 완료 (예상)

2022년 12월 31일

연구 등록 날짜

최초 제출

2021년 4월 7일

QC 기준을 충족하는 최초 제출

2021년 5월 5일

처음 게시됨 (실제)

2021년 5월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 26일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • ScoliosisAPP

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Treatment as usual + APP에 대한 임상 시험

구독하다