To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico (ECOS MEX)
This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
|Study Design:||Observational Model: Cohort|
|Official Title:||Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Mexico|
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 4 years ] [ Designated as safety issue: No ]
- Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [ Time Frame: At least 6 months and up to 4 years ] [ Designated as safety issue: No ]Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS)) after each year of SAIZEN® treatment with easypod™
- Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 4 years ] [ Designated as safety issue: Yes ]
- Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) [ Time Frame: At least 6 months and up to 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatotropin
Subjects will be enrolled in a multicenter longitudinal observational study. Parents and patients will provide their Informed Consent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program "AUMENTA" 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.
-To assess the level of adherence of subjects receiving SAIZEN® via easypod™
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
- To identify adherence subject profiling
- To asses the impact of adherence on IGF1 (i.e. above, below or within normal ranges)
- To assess/describe the impact of Mexico patient support program "AUMENTA"
|Contact: Merck KGaA Communication Centeremail@example.com|
|For Recruiting Locations in Mexico||Recruiting|
|please contact the Merck KGaA Communication Center, Mexico|
|Contact: Merck KGaA Communication Center +49-6151-72-5200 firstname.lastname@example.org|
|Study Director:||Medical Director||Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt,|