Genotropin Study Assessing Use of Injection Pen

Study Overview
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Brief Summary
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Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.

Official Title
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Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen

Conditions
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Growth Hormone Deficiency, Idiopathic Short Stature

Intervention / Treatment
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* Device: New Genotropin Pen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 8-18 years Using genotropin pen for at least 3 months prior to study enrollment Compliance with genotropin treatment Exclusion Criteria: Medical conditions that can affect participation in study Insufficient command of English language to understand questionnaire Using other growth hormone device and not Genotropin pen

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotropin pen<br>All subjects will receive genotropin pen to use for 2 months. | Device: New Genotropin Pen<br>* Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® | Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® | Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference). | 2 months | 
| Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen® | Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference). | 2 months | 
| Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen® | Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference). | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotropin Medical device Patient reported outcome