Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Develop a Personalized Growth Hormone Treatment Profile (PGTP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Develop a Personalized Growth Hormone Treatment Profile (PGTP)
时间窗: From enrollment to the end of the study at Month 12
To develop a Personalized Growth Hormone Treatment Profile (PGTP) standard - analogous to the Ambulatory Glucose Profile (AGP) for diabetes care-, integrating diverse data sources to support personalized treatment strategies in pediatric endocrinology.
次要结局
- Adherence to Treatment Using Connected Injector Devices(From enrollment to the end of the study at Month 12)
- Physiological Monitoring via Wearable Devices - Sleep Quality(From enrollment to the end of the study at Month 12)
- Physiological Monitoring via Wearable Devices - Heart Rate(From enrollment to the end of the study at Month 12)
- Physiological Monitoring via Wearable Devices - Physical Activity Metrics(From enrollment to the end of the study at Month 12)
- Physiological Monitoring via Wearable Devices - Blood Oxygen Levels(From enrollment to the end of the study at Month 12)
- Evaluating Usability of Connected Devices(From enrollment to the end of the study at Month 12)
- Mobile Application Engagement(From enrollment to the end of the study at Month 12)
- Distress Assessment 2(From enrollment to the end of the study at Month 12)
- Self-Efficacy Assessment(From enrollment to the end of the study at Month 12)
- Mood Assessment(From enrollment to the end of the study at Month 12)
- Mental Health and Well-Being Assessment(From enrollment to the end of the study at Month 12)
- Health-Related Quality of Life (HRQoL)(From enrollment to the end of the study at Month 12)
研究者
Luis Fernandez Luque
Chief Scientific Officer
Adhera Health, Inc.