Development and Validation of a Novel Self-assessment System based on Mobile App to Manage Adult Growth Hormone Deficiency: a Single-Centre Model.

Background: Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients’ awareness of the disease, low perceived benefit of replacement therapy and poor compliance still remains.

 

Overall goal: to improve AGHD management through a Smartphone app (MAGHD App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to merge patients daily data on physical activity, quality of life (QoL), and well-being with clinical data collected in institutional databases. 

 

Target population: 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not.

 

Methods: In a prospective 24 months study, MAGHD App will be developed, connected to MAGHD Framework and validated on 100 AGHD patients. This system will allow to integrate: 1) Physical Activity Data collected by wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP Data registered in clinical databases and including medical history, biochemical and radiological examination. Data will converge in MAGHD Framework where they will be analyzed and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring dashboard). 

 

Assessment: The primary outcomes will be evaluated by determining the impact of MAGHD App/Framework on: 1) patients’ QoL, well-being, physical activity, 2) patient-clinician communication, 3) patients’ compliance to replacement therapy. The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.