Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
NCT ID: NCT06830525
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2025-05-19
2025-11-12
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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%.
ACDP® and growth hormone treatment
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.
Interventions
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ACDP® and growth hormone treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
Yes
Sponsors
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Hospital Miguel Servet
OTHER
Luis Fernandez Luque
INDUSTRY
Responsible Party
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Luis Fernandez Luque
Chief Scientific Officer
Locations
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Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Countries
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Other Identifiers
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PGTP
Identifier Type: -
Identifier Source: org_study_id
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