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

NCT04881591 | Unknown

• 1 other identifier: ScoliosisAPP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence; Brace

Keywords

ICT; Treatment Adherence; Treatment efficacy; Treatment safety

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• 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

  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

  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

  Twice: at baseline (beggining of the study, before the brace use) and at end of the study (3 months after app first use)

• Mood

  Daily up to 3 months

Study Arms (1)

APP+Usual Treatment

EXPERIMENTAL

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.

Device: Treatment as usual + APP

Interventions

Treatment as usual + APP DEVICE

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.

APP+Usual Treatment

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Vall d'Hebron Hospital

Barcelona, Spain

RECRUITING

Related Publications (16)

• Aebi M. The adult scoliosis. Eur Spine J. 2005 Dec;14(10):925-48. doi: 10.1007/s00586-005-1053-9. Epub 2005 Nov 18.

  PMID: 16328223 BACKGROUND

• Charosky S, Guigui P, Blamoutier A, Roussouly P, Chopin D; Study Group on Scoliosis. Complications and risk factors of primary adult scoliosis surgery: a multicenter study of 306 patients. Spine (Phila Pa 1976). 2012 Apr 15;37(8):693-700. doi: 10.1097/BRS.0b013e31822ff5c1.

  PMID: 22504517 BACKGROUND

• D'Astous JL, Sanders JO. Casting and traction treatment methods for scoliosis. Orthop Clin North Am. 2007 Oct;38(4):477-84, v. doi: 10.1016/j.ocl.2007.03.006.

  PMID: 17945127 BACKGROUND

• Dunn J, Henrikson NB, Morrison CC, Blasi PR, Nguyen M, Lin JS. Screening for Adolescent Idiopathic Scoliosis: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):173-187. doi: 10.1001/jama.2017.11669.

  PMID: 29318283 BACKGROUND

• Fong DY, Lee CF, Cheung KM, Cheng JC, Ng BK, Lam TP, Mak KH, Yip PS, Luk KD. A meta-analysis of the clinical effectiveness of school scoliosis screening. Spine (Phila Pa 1976). 2010 May 1;35(10):1061-71. doi: 10.1097/BRS.0b013e3181bcc835.

  PMID: 20393399 BACKGROUND

• Janicki JA, Alman B. Scoliosis: Review of diagnosis and treatment. Paediatr Child Health. 2007 Nov;12(9):771-6. doi: 10.1093/pch/12.9.771.

  PMID: 19030463 BACKGROUND

• Lenssinck ML, Frijlink AC, Berger MY, Bierman-Zeinstra SM, Verkerk K, Verhagen AP. Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials. Phys Ther. 2005 Dec;85(12):1329-39.

  PMID: 16305271 BACKGROUND

• Morton A, Riddle R, Buchanan R, Katz D, Birch J. Accuracy in the prediction and estimation of adherence to bracewear before and during treatment of adolescent idiopathic scoliosis. J Pediatr Orthop. 2008 Apr-May;28(3):336-41. doi: 10.1097/BPO.0b013e318168d154.

  PMID: 18362800 BACKGROUND

• Negrini S, Atanasio S, Zaina F, Romano M. Rehabilitation of adolescent idiopathic scoliosis: results of exercises and bracing from a series of clinical studies. Europa Medicophysica-SIMFER 2007 Award Winner. Eur J Phys Rehabil Med. 2008 Jun;44(2):169-76.

  PMID: 18418337 BACKGROUND

• Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

  PMID: 29435499 BACKGROUND

• Reichel D, Schanz J. Developmental psychological aspects of scoliosis treatment. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):221-5. doi: 10.1080/13638490310001644593.

  PMID: 14713589 BACKGROUND

• Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618.

  PMID: 29659375 BACKGROUND

• Tones M, Moss N, Polly DW Jr. A review of quality of life and psychosocial issues in scoliosis. Spine (Phila Pa 1976). 2006 Dec 15;31(26):3027-38. doi: 10.1097/01.brs.0000249555.87601.fc.

  PMID: 17173000 BACKGROUND

• Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.

  PMID: 18456103 BACKGROUND

• Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.

  PMID: 25269032 BACKGROUND

• Yang S, Andras LM, Redding GJ, Skaggs DL. Early-Onset Scoliosis: A Review of History, Current Treatment, and Future Directions. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-0709. Epub 2015 Dec 7.

  PMID: 26644484 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Treatment Adherence and Compliance

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Health Behavior; Behavior

Study Officials

• Azucena García-Palacios, PhD

  Universitat Jaume I

  STUDY CHAIR

• Judith Sánchez-Raya, PhD

  Hospitla Universitario Vall d'Hebron

  STUDY CHAIR

• Amanda Díaz-García, PhD

  Universidad de Zaragoza

  STUDY CHAIR

• Diana Castilla, PhD

  University of Valencia

  STUDY CHAIR

• Verónica Martínez-Borba, MsC

  Universitat Jaume I

  STUDY CHAIR

Central Study Contacts

Carlos Suso-Ribera, PhD

CONTACT

670421577; susor@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be informed of the condition they have been assigned to.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One condition

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: May 11, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)