Smartphone App for Adolescents With Idiopathic Scoliosis

Official title

Evaluating the Impact of a Smartphone App on Health Outcomes and Treatment Adherence in Adolescents With Idiopathic Scoliosis: A Mixed Method Quasi-Experimental Study

Overview

This study aims to evaluate a smartphone application (DinSkoliose) designed to support adolescents with idiopathic scoliosis (AIS) in managing their condition and following their treatment. Adolescents with AIS often find it challenging to adhere to conservative treatment, such as wearing a brace or performing physiotherapy exercises. The app was developed specifically for this study as a theory-informed digital health intervention to support self-management and treatment adherence. It includes features such as symptom tracking, educational content, reminders, and social support. Participants will use the app for 12 weeks in their everyday environment alongside their usual care. They will complete questionnaires before and after the intervention and participate in an interview to share their experiences. The study will examine whether the app can improve health-related behaviors, including treatment adherence and self-management, and whether it is feasible and acceptable for adolescents with scoliosis.The app is meant to complemen the current AIS treatment, doesn't substitute it.

Detailed description

This study is a quasi-experimental, one-group pretest-posttest study designed to evaluate the feasibility, acceptability, and preliminary effectiveness of a smartphone application (DinSkoliose) for adolescents with idiopathic scoliosis (AIS).

AIS is a common spinal condition that often requires long-term conservative treatment, including brace use and physiotherapy scoliosis-specific exercises. Treatment success is highly dependent on adherence; however, adherence is often limited by physical discomfort, psychological factors, and lack of continuous support.

The DinSkoliose app is a personalized, theory-informed digital health intervention developed specifically for this study using a user-centered co-design approach. The app is grounded in behavioral theories of motivation and self-management and includes features to support treatment adherence, such as tracking of brace use and exercises, monitoring of symptoms (e.g., pain and mood), educational information, reminders, and structured social support.

Participants will use the app over a 12-week period in their natural environment alongside their usual care, with no additional clinical intervention. Outcomes will be assessed at baseline and post-intervention using validated questionnaires measuring health behaviors, self-management, self-efficacy, social support, and patient activation. App usability, engagement, and acceptability will also be evaluated.

In addition, semi-structured interviews will be conducted after the intervention to explore participants' experiences and identify strengths and areas for improvement. The results will inform further development of the app and future evaluation in larger controlled studies.

Interventions

• Device DinSkoliose smartphone application
  The intervention consists of the use of the DinSkoliose smartphone application, a personalized digital health tool specifically developed for this study. The app is designed to support adolescents with idiopathic scoliosis in managing their condition and improving adherence to conservative treatment. The app includes features for monitoring brace use and physiotherapy exercises, tracking symptoms such as pain and mood, providing educational content, sending reminders, and offering structured so

Primary outcome measures

• Change in Health Behaviors Outcome [Time frame: Baseline to 12 weeks]
• Change in behavioral impact (such as self-management of AIS) [Time frame: Baseline to 12 weeks]
• Change in motivation for exercise measured by SDT-based Motivation for Exercise questionnaire [Time frame: Baseline to 12 weeks]

Secondary outcome measures (4)

• User engagement measured by User Engagement Scale (UES) [Time frame: Week 6 and Week 12]
• Change in perceived social support measured by Medical Outcomes Study Social Support Survey (MOS-SSS) [Time frame: Baseline to 12 weeks]
• App usability and acceptability measured by Mobile App Rating Scale (MARS) [Time frame: Week 6 and Week 12]
• Participant experiences and perceived impact assessed through semi-structured interviews [Time frame: At 12 weeks (post-intervention)]

Eligibility criteria

The study population will consist of adolescent patients with AIS.

The Inclusion criteria for participants in our study are those:

• who are diagnosed with AIS;
• who give written informed consent,
• who are at the age between 10 - 24 years old;
• under 16 years old for whom parental consent has been provided (as required by the National Research Ethics Committee);
• who can speak, read, and write in Norwegian or English;
• who have access to and ability to use smart phone;
• who have internet access.

The Exclusion criteria for participants in our study are those who:

• have a history of other type of scoliosis (such as congenital, neuromuscular, degenerative);
• are younger than 10 years old and older than 24 years old;
• have any additional diagnosis that could affect the intervention outcome (severe mental health disorders or diagnosis of a developmental disorder that prevents understanding and compliance with intervention, leg length discrepancy).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 1 center

• OsloMet — Oslo

Publications

• Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500. PMID 30973342
• Zelmer J, van Hoof K, Notarianni M, van Mierlo T, Schellenberg M, Tannenbaum C. An Assessment Framework for e-Mental Health Apps in Canada: Results of a Modified Delphi Process. JMIR Mhealth Uhealth. 2018 Jul 9;6(7):e10016. doi: 10.2196/10016. PMID 29986846
• Yoo H, Kim CJ, Jang Y, You MA. Self-efficacy associated with self-management behaviours and health status of South Koreans with chronic diseases. Int J Nurs Pract. 2011 Dec;17(6):599-606. doi: 10.1111/j.1440-172X.2011.01970.x. PMID 22103826
• Yin, M., Tayyab, S. M. U., Xu, X. Y., Jia, S. W., & Wu, C. L. (2021). The investigation of mobile health stickiness: the role of social support in a sustainable health approach. Sustainability, 13(4), 1693. https://doi.org/10.3390/su13041693
• Wolniak, R. (2017). The Design Thinking method and its stages. Systemy wspomagania w inżynierii produkcji, 6(6), 247-255
• Wellburn S, van Schaik P, Bettany-Saltikov J. The Information Needs of Adolescent Idiopathic Scoliosis Patients and Their Parents in the UK: An Online Survey. Healthcare (Basel). 2019 Jun 20;7(2):78. doi: 10.3390/healthcare7020078. PMID 31226769
• Sykorova, K., Pavel, N., Mathew, A., Johnsen, M. B., Lystad, J. U., Bull, H. C., Gazerani, P., Kvammen, M. F., He, H.-G., Jacoby, J., & Pikkarainen, M. A. (under review). Understanding the needs and frustrations in adolescent idiopathic scoliosis: A qualitative interview study. Submitted to BMC Musculoskeletal Disorders.
• Sykorova, K., Mathew, A., Pavel, N., Gazerani, P., Fløystad, M. K., Wlosek, N., Bong, W. K., Saidi, T., Johnsen, M. B., He, H.-G., & Pikkarainen, M. (2026). Co-designing a scoliosis self-management mobile app with adolescents and parents: A theory-informed qualitative study [Preprint]. JMIR Preprints. https://doi.org/10.2196/preprints.95698

Identifiers

NCT: NCT07686848 · 933077

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗