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Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment in Greece
This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in Greece and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.
Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies. Primary Objective: \- To assess the level of adherence of subjects receiving SAIZEN® via Easypod™ Secondary Objectives: * To identify adherence subject profiling * To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™ * To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges) * To assess/describe the impact of the Greek Scientific Service (Patient Support Program)
Age
2 - 18 years
Sex
ALL
Healthy Volunteers
No
For Recruiting Locations in Greece,
Please Contact the Merck KGaA Communication Center, Greece
Start Date
April 30, 2013
Primary Completion Date
December 31, 2015
Completion Date
December 31, 2015
Last Updated
December 26, 2017
180
ACTUAL participants
Easypod™
DEVICE
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
NCT06662045
NCT05382637
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02413138