CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
Use of "MAGHD App/MAGHD Framework"other
Likely dose
Not stated in record
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Search/NCT03525587
NCT03525587N/ACompleted

Development and Validation of a Novel Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency (MAGHD App): a Single-Centre Model. GrASS (Growth Hormone Deficiency in Adults Self-assessment System)

Azienda Ospedaliero-Universitaria di Modena·interventional·Posted May 15, 2018·Updated Mar 14, 2025

In Brief

A clinical study evaluating Use of "MAGHD App/MAGHD Framework" for Growth Hormone Deficiency. Completed, enrolled 83 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsPfizer

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartJan 17, 2018
Primary CompletionJun 30, 2020
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.1 years ago

Interventions

Use of "MAGHD App/MAGHD Framework"other

Patients daily related outcomes will be recorded thanks to the development, implementation and validation of a Smartphone app (MAGHD App) integrated with a software framework able to merge patient's daily activities data on well-being status, QoL, physical activities and sexual function with clinical data collected in their record chart (extrapolated from already available Institutional Databases).