Scoliosis Idiopathic Clinical Trial
Official title:
Improving Adherence and Safety of Orthopedic Treatment of Idiopathic Scoliosis in Adolescents Using Information and Communication Technologies
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).
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Vall d'Hebron Hospital | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I |
Spain,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | App' usability will be assessed by the SUS | 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) | |
Primary | App' usability will be assessed by the SUS | 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) | |
Primary | App' acceptability will be assessed by the SUS | 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) | |
Primary | App' acceptability will be assessed by the SUS | 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) | |
Primary | Feasibility of the study will be assessed by a calculation of responses completed | 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) | |
Secondary | Stress | 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) | |
Secondary | Patients' Quality of life | 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) | |
Secondary | Perceived health status | 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) | |
Secondary | Anxiety and depressive symptoms | 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) | |
Secondary | Mood | Questions adapted and validated from the Profile of Mood States and Short Form 12 | Daily up to 3 months | |
Secondary | Brace adherence | Adherence will be calculated by dividing the number of hours of use reported and the prescription filled | Daily up to 3 months | |
Secondary | Treatment safety: Brace-related side effects | 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 |
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