Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocr… (NCT06830525) | Clinical Trial Compass
CompletedNot Applicable
Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
Spain40 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Develop a Personalized Growth Hormone Treatment Profile (PGTP)
Timeframe: From enrollment to the end of the study at Month 12