Smartphone App for Adolescents With Idiopathic Scoliosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-24
SponsorOslo Metropolitan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
DinSkoliose smartphone application
DeviceThe 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 social support. Participants will use the app independently in their everyday environment over a 12-week period alongside their usual care. No additional treatment will be provided.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention: DinSkoliose AppExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Health Behaviors Outcome
Change in health behaviour outcomes, including self-management, knowledge, skills, and confidence, measured using the Patient Activation Measure (PAM). PAM is a validated 13-item questionnaire with scores ranging from 0 to 100, where higher scores indicate greater patient activation and improved health behaviour.
Time frame
Baseline to 12 weeks2
Change in behavioral impact (such as self-management of AIS)
Change in self-efficacy, defined as participants' confidence in their ability to manage their condition, perform health-related behaviors, and cope with symptoms, measured using the Chronic Disease Self-Efficacy Scale (CDSES). Scores range from 1 to 10, with higher scores indicating greater self-efficacy.
Time frame
Baseline to 12 weeks3
Change in motivation for exercise measured by SDT-based Motivation for Exercise questionnaire
Change in motivation for exercise measured using a Self-Determination Theory (SDT)-based Motivation for Exercise questionnaire, assessing different types of motivational regulation (external, introjected, identified, and intrinsic motivation). Scores reflect the degree of autonomous versus controlled motivation, with higher autonomous motivation indicating more self-determined and sustainable health behaviour.
Time frame
Baseline to 12 weeksSecondary outcomes
1
User engagement measured by User Engagement Scale (UES)
User engagement measured using the User Engagement Scale (UES), a validated questionnaire assessing multiple dimensions of engagement including focused attention, perceived usability, aesthetic appeal, and reward-related engagement. Responses are rated on a Likert scale, and higher scores indicate greater user engagement with the intervention.
Time frame
Week 6 and Week 122
Change in perceived social support measured by Medical Outcomes Study Social Support Survey (MOS-SSS)
Change in perceived social support measured using the Medical Outcomes Study Social Support Survey (MOS-SSS), a validated questionnaire assessing emotional/informational support, tangible support, positive social interaction, and affectionate support. Scores are calculated on a Likert scale, with higher scores indicating greater perceived social support.
Time frame
Baseline to 12 weeks3
App usability and acceptability measured by Mobile App Rating Scale (MARS)
App usability and acceptability measured using the Mobile App Rating Scale (MARS), which evaluates app quality across multiple domains including engagement, functionality, aesthetics, and information quality. Items are rated on a 5-point scale, with higher scores indicating better app quality and acceptability.
Time frame
Week 6 and Week 124
Participant experiences and perceived impact assessed through semi-structured interviews
Participant experiences, perceptions, and perceived impact of the intervention assessed through semi-structured qualitative interviews. Interviews explore app usability, engagement, perceived effects on health behaviour, self-management, and psychosocial well-being. Data will be analyzed using thematic analysis.
Time frame
At 12 weeks (post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo Metropolitan University
Lead sponsor
Oslo University Hospital
Collaborator
Ryggforeningen i Norge, Norway
Collaborator
Source ClinicalTrials.gov
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