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Development and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency

CompletedNA

Sponsor: Azienda Ospedaliero-Universitaria di Modena

Conditions: Growth Hormone Deficiency

Interventions: Use of "MAGHD App/MAGHD Framework"

Countries: Italy

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. The overall goal of the study is 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. The target population consists of 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not. In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD Framework. 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). The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Having a documented diagnosis of AGHD, according to the latest Endocrine Society clinical practice guidelines
2. Being at least 18 years old
3. Having a good Italian understanding
4. Owing smartphones with either an Android or iPhone operating system
5. Patients with other pituitary deficits will be enrolled only if the other hormonal deficiencies are well controlled by replacement treatments since six months in order to avoid the overlap of effects due to different therapies.

Exclusion Criteria:

1\) Patients who do not plan to continue follow-up at the Endocrinology Unit of Modena 2) Patients with a diagnosis of biochemical GHD outside the appropriate clinical context of pituitary disease 3) Patients with major psychiatric diseases, chronic highly invalidating diseases (these patients will be considered not eligible for being enrolled in the study due to the impact of the underlying disease on well-being and daily activities).

Locations (1)

Modena, Modena, Italy