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NCT Number: NCT06830525

Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology

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.

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Key information

Conditions

Growth Hormone Deficiency (GHD) Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients (up to 18 years old) diagnosed with growth hormone deficiency or disorders requiring growth hormone treatment.
  • Patients are currently undergoing growth hormone therapy. Includes both naive patients (those newly starting weekly treatment) and those already on treatment.
  • Families willing to use connected injector devices and participate in mobile-based psychometrics for the study duration.
  • Families are able and willing to regularly provide patient-reported outcomes (PROs) and adherence data through the Adhera®️ Caring Digital Program.
  • Participants willing to sign the informed consent form, confirming their understanding of the essential aspects of the study, including the potential risks, benefits and rights as participants.

Exclusion criteria

  • Families/patients already enrolled in other study protocols, including the use of connected injector devices and participation in mobile-based psychometrics.
  • Patients with other significant medical conditions that could interfere with growth hormone treatment or the study's data collection processes.
  • Inability to understand or communicate in the language used for data collection and study participation, unless appropriate translation services are available and can be consistently utilized.

Treatment and study plan

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.

Primary outcomes

  1. Develop a Personalized Growth Hormone Treatment Profile (PGTP)

    Time frame: From enrollment to the end of the study at Month 12

    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.

Secondary outcomes

  1. Adherence to Treatment Using Connected Injector Devices

    Time frame: From enrollment to the end of the study at Month 12

    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.

  2. Physiological Monitoring via Wearable Devices - Sleep Quality

    Time frame: From enrollment to the end of the study at Month 12

    Unit of Measure:

    • Total sleep duration (hours per night). Description: Sleep parameters will be tracked using wearable devices.

  3. Physiological Monitoring via Wearable Devices - Heart Rate

    Time frame: From enrollment to the end of the study at Month 12

    Unit of Measure: Average daily heart rate (beats per minute, bpm). Description: Daily average heart rate recorded through wearable devices.

  4. Physiological Monitoring via Wearable Devices - Physical Activity Metrics

    Time frame: From enrollment to the end of the study at Month 12

    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.

  5. Physiological Monitoring via Wearable Devices - Blood Oxygen Levels

    Time frame: From enrollment to the end of the study at Month 12

    Unit of Measure: Daily oxygen saturation percentage (%). Description: Measured through wearable device sensors.

  6. Evaluating Usability of Connected Devices

    Time frame: From enrollment to the end of the study at Month 12

    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.

  7. Mobile Application Engagement

    Time frame: From enrollment to the end of the study at Month 12

    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).

  8. Distress Assessment 2

    Time frame: From enrollment to the end of the study at Month 12

    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.

  9. Distress Assessment 2

    Time frame: From enrollment to the end of the study at Month 12

    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.

  10. Self-Efficacy Assessment

    Time frame: From enrollment to the end of the study at Month 12

    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.

  11. Mood Assessment

    Time frame: From enrollment to the end of the study at Month 12

    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.

  12. Mental Health and Well-Being Assessment

    Time frame: From enrollment to the end of the study at Month 12

    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.

  13. Health-Related Quality of Life (HRQoL)

    Time frame: From enrollment to the end of the study at Month 12

    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.

Sponsors and collaborators

Lead sponsor

Luis Fernandez Luque

Industry

Collaborators

  • Hospital Miguel Servet

Registry information

Acronym: PGTP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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