Evaluating the Impact of a Smartphone App on Health Outcomes and Treatment Adherence in Adolescents With Idiopathic Scoliosis: A Mixed Method Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Health Behaviors Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Health Behaviors Outcome
时间窗: Baseline to 12 weeks
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.
Change in behavioral impact (such as self-management of AIS)
时间窗: Baseline to 12 weeks
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.
Change in motivation for exercise measured by SDT-based Motivation for Exercise questionnaire
时间窗: Baseline to 12 weeks
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.
次要结局
- User engagement measured by User Engagement Scale (UES)(Week 6 and Week 12)
- Change in perceived social support measured by Medical Outcomes Study Social Support Survey (MOS-SSS)(Baseline to 12 weeks)
- App usability and acceptability measured by Mobile App Rating Scale (MARS)(Week 6 and Week 12)
- Participant experiences and perceived impact assessed through semi-structured interviews(At 12 weeks (post-intervention))