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| Name | Class |
|---|---|
| Hospital Miguel Servet | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families with children undergoing growth hormone treatment | The study targets families of children with growth hormone deficiency (GHD) under growth hormone treatment, using a connected injector device that quantifies treatment adherence. We will recruit 40 families, divided into two groups: one group with adherence rates of <85%, and the other group with adherence rates of >85%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACDP® and growth hormone treatment | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the study at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the study at Month 12 |
| Physiological Monitoring via Wearable Devices - Sleep Quality |
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Inclusion Criteria:
Exclusion Criteria:
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The sample of the study (children and their caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants.
Families of children undergoing growth hormone therapy and are willing to join a combined intervention.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Miguel Servet | Zaragoza | Aragon | Spain |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C067723 | 2-amino-3-cyano-6-methyl-5-(3,4-dimethoxyphenyl)pyridine |
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Unit of Measure: - Total sleep duration (hours per night). Description: Sleep parameters will be tracked using wearable devices. |
| 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. | From enrollment to the end of the study at Month 12 |
| Physiological Monitoring via Wearable Devices - Physical Activity Metrics | Unit of Measure:
Description: Data will be collected from wearable devices to assess daily physical activity. | 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. | 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. | 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). | 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. | 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. | 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. | From enrollment to the end of the study at Month 12 |
| Mood Assessment | Positive and Negative Affect Schedule (PANAS) Unit of Measure:
Description: PANAS is a self-report questionnaire measuring two dimensions of mood: positive and negative affect. | 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. | 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. | From enrollment to the end of the study at Month 12 |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |