Personalized growth hormone treatment for children
Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
This study is testing a new way to personalize growth hormone treatment for children with growth hormone deficiency by using a special device that tracks their treatment and gathers their feedback.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Adhera Health, Inc. Industry-sponsored |
| Locations | 1 site (Zaragoza, Aragon) |
| Trial ID | NCT06830525 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the personalization of growth hormone treatment for pediatric patients with growth hormone deficiency. It will involve 40 families using a connected injector device that tracks treatment adherence, alongside surveys to gather patient experiences. The collected data will help develop a new tool to assist doctors in creating tailored treatment plans for each child, similar to existing tools in diabetes care. The study focuses on understanding how adherence and patient feedback can improve care.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients up to 18 years old diagnosed with growth hormone deficiency who are currently undergoing growth hormone therapy.
Not a fit: Patients already enrolled in other study protocols or those with significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and individualized growth hormone treatments for children.
How similar studies have performed: While this approach is innovative, similar studies in diabetes care have shown success in personalizing treatment based on patient data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zaragoza, Aragon
- Hospital Universitario Miguel Servet — Zaragoza, Aragon, Spain (Recruiting)
Study contacts
- Study coordinator: Luis Fernadez-Luque, Dr
- Email: luis@adherahealth.com
- Phone: +34 656930901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.