Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training

Study Overview
=================
Brief Summary
-----------------
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

Detailed Description
-----------------
This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.

Official Title
-----------------
A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials

Conditions
-----------------
Immune Thrombocytopenic Purpura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, (2) has received HAT pack training, (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, (4) patient provides informed consent. Exclusion Criteria: -No exclusion criteria for this observational study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single arm<br>single arm study | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful self administration of romiplostim | to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack. | First Standard of Care visit post Home Administration Training (range 2-8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful reconstitution of romiplostim | A yes/no indicator of whether the subject or caregiver reconstitutes romiplostim correctly. | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | 
| Accuracy in administering the prescribed dose of romiplostim | The difference between the prescribed and administered dose of romiplostim, expressed as a %. | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | 
| Injects romiplostim | A yes/no indicator of whether the subject or caregiver injects romiplostim successfully. | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | 
| Administers romiplostim | A yes/no indicator of whether the subject or caregiver administers romiplostim correctly. | Follow up visits (up to 16 weeks post enrolment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nplate,, romiplostim,, immune thrombocytopenic purpura