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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04881591
Other study ID # ScoliosisAPP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2022

Study information

Verified date July 2021
Source Universitat Jaume I
Contact Carlos Suso-Ribera, PhD
Phone 670421577
Email susor@uji.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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Study Design


Intervention

Device:
Treatment as usual + APP
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.

Locations

Country Name City State
Spain Vall d'Hebron Hospital Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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Outcome

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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