The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are: * How can information about treatment adherence and patient experiences help improve care? * What insights can help doctors create treatment plans that are more tailored to each child? The study will include 40 families of children who are using a connected injector device for their growth hormone treatment. These devices track how often the treatment is taken, and families will also share their experiences through surveys. The information will be used to develop a new tool, similar to tools used in diabetes care, to help doctors create better, personalized treatment plans for children with growth hormone needs.
Study Type
OBSERVATIONAL
Enrollment
40
A cohort of 40 families of children undergoing growth hormone treatment using a connected injector devices that quantifies treatment adherence will be recruited via the ACDP®, to capture additional data that combine Patient Reported Outcomes and Adherence Data.
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Develop a Personalized Growth Hormone Treatment Profile (PGTP)
To develop a Personalized Growth Hormone Treatment Profile (PGTP) standard - analogous to the Ambulatory Glucose Profile (AGP) for diabetes care-, integrating diverse data sources to support personalized treatment strategies in pediatric endocrinology.
Time frame: From enrollment to the end of the study at Month 12
Adherence to Treatment Using Connected Injector Devices
Automated tracking of injection times and adherence. Adherence will be quantified through connected injector device data, capturing timestamps of each injection and calculating adherence rates.
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Sleep Quality
Unit of Measure: \- Total sleep duration (hours per night). Description: Sleep parameters will be tracked using wearable devices.
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Heart Rate
Unit of Measure: Average daily heart rate (beats per minute, bpm). Description: Daily average heart rate recorded through wearable devices.
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Physical Activity Metrics
Unit of Measure: * Total calories burned per day (kilocalories, kcal). * Total steps per day (steps). * Total activity time per day (minutes). Description: Data will be collected from wearable devices to assess daily physical activity.
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Blood Oxygen Levels
Unit of Measure: Daily oxygen saturation percentage (%). Description: Measured through wearable device sensors.
Time frame: From enrollment to the end of the study at Month 12
Evaluating Usability of Connected Devices
Outcome Measure: System Usability Scale (SUS) score. Unit of Measure: SUS score (0-100, higher scores indicate better usability). Description: The System Usability Scale (Bangor et al., 2008) is a 10-item scale based on a 5-point Likert scale assessing perceived usability.
Time frame: From enrollment to the end of the study at Month 12
Mobile Application Engagement
Outcome Measure: User engagement with the mobile application. Unit of Measure: Frequency of interactions (e.g., number of logins per day/week). Description: Engagement will be assessed using mobile user logs, including user profiling metrics based on Hors-Fraile et al. (2018).
Time frame: From enrollment to the end of the study at Month 12
Distress Assessment 2
Distress Thermometer Unit of Measure: Score on a 0-10 scale (higher scores indicate higher distress). Description: The Distress Thermometer is a single-item, self-report tool measuring psychological distress on a 0-10 scale.
Time frame: From enrollment to the end of the study at Month 12
Distress Assessment 2
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) Unit of Measure: Score range 0-63 (higher scores indicate greater distress). Description: The DASS-21 is a 21-item scale measuring general affective distress, including depression, anxiety, and stress, over the past week.
Time frame: From enrollment to the end of the study at Month 12
Self-Efficacy Assessment
General Self-Efficacy Scale (GSE) Unit of Measure: Score range 10-40 (higher scores indicate greater self-efficacy). Description: The GSE scale measures an individual's belief in their ability to cope with adversity.
Time frame: From enrollment to the end of the study at Month 12
Mood Assessment
Positive and Negative Affect Schedule (PANAS) Unit of Measure: * Positive Affect (PA) score range: 10-50 (higher scores indicate greater positive affect). * Negative Affect (NA) score range: 10-50 (higher scores indicate greater negative affect). Description: PANAS is a self-report questionnaire measuring two dimensions of mood: positive and negative affect.
Time frame: From enrollment to the end of the study at Month 12
Mental Health and Well-Being Assessment
Mental Health Continuum-Short Form (MHC-SF) Unit of Measure: Score range 0-70 (higher scores indicate better mental health). Description: The MHC-SF is a 14-item scale assessing emotional, social, and psychological well-being as indicators of positive mental health.
Time frame: From enrollment to the end of the study at Month 12
Health-Related Quality of Life (HRQoL)
KIDSCREEN-10 Unit of Measure: Score range 10-50 (higher scores indicate better health-related quality of life). Description: The KIDSCREEN-10 is a health-related quality of life measure for children and adolescents, assessing physical, psychological, and social well-being, autonomy, school environment, and peer and family support.
Time frame: From enrollment to the end of the study at Month 12
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