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

Luis Fernandez Luque

Status: Completed

Conditions: Growth Hormone Deficiency (GHD)

Treatments: Combination Product: ACDP® and growth hormone treatment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06830525

PGTP

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Families with children undergoing growth hormone treatment

Description:

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%.

Treatment:

Combination Product: ACDP® and growth hormone treatment