Clinical trial NCT06830525: Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
Official title: Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Hormone Deficiency (GHD)
Keywords: Growth Hormone Disorder
Digital health
pediatric endocrinology
Personalized Growth Hormone Treatment Profile
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Miguel Servet
First posted: 2025-02-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Develop a Personalized Growth Hormone Treatment Profile (PGTP)
timeFrame: From enrollment to the end of the study at Month 12
Secondary outcomes:
measure: Adherence to Treatment Using Connected Injector Devices
timeFrame: From enrollment to the end of the study at Month 12
measure: Physiological Monitoring via Wearable Devices - Sleep Quality
timeFrame: From enrollment to the end of the study at Month 12
measure: Physiological Monitoring via Wearable Devices - Heart Rate
timeFrame: From enrollment to the end of the study at Month 12
measure: Physiological Monitoring via Wearable Devices - Physical Activity Metrics
timeFrame: From enrollment to the end of the study at Month 12
measure: Physiological Monitoring via Wearable Devices - Blood Oxygen Levels
timeFrame: From enrollment to the end of the study at Month 12
measure: Evaluating Usability of Connected Devices
timeFrame: From enrollment to the end of the study at Month 12
measure: Mobile Application Engagement
timeFrame: From enrollment to the end of the study at Month 12
measure: Distress Assessment 2
timeFrame: From enrollment to the end of the study at Month 12
measure: Distress Assessment 2
timeFrame: From enrollment to the end of the study at Month 12
measure: Self-Efficacy Assessment
timeFrame: From enrollment to the end of the study at Month 12
measure: Mood Assessment
timeFrame: From enrollment to the end of the study at Month 12
measure: Mental Health and Well-Being Assessment
timeFrame: From enrollment to the end of the study at Month 12
measure: Health-Related Quality of Life (HRQoL)
timeFrame: From enrollment to the end of the study at Month 12
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragon
Study officials:
References: