Hemophilia A and B
Conditions
Keywords
hemophilia
Brief summary
This pilot study will have patients use a smart sharps disposal container at home for disposal of needles used to administer their hemophilia drugs. The study aims to find out if the smart sharps container proved acceptable to use by patients and medical providers and can be adhered to.
Detailed description
Preventative factor or non-factor product IV administration has been shown to improve outcomes in patients with hemophilia. The need for patients to log their doses or complete questionnaires can be burdensome. This study seeks to use novel technology, a smart sharps container that records disposal of the needle used to administer preventive products. We will perform a prospective study of adult patients with hemophilia A/B who are on factor or non-factor products. They will all be given the device to take home and use there.
Interventions
OTHERThe smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.
The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.
Sponsors
University of Pennsylvania
Sharpscue
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Everyone gets a Sharps needle disposal device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Male or female, ≥18 years of age * Moderate or Severe Hemophilia A or B, with or without an inhibitor * Prescribed prophylaxis with either a factor product or emicizumab that is scheduled to be given at least once every 14 days Exclusion: * Stated inability to use the SharpsCue container * Treatment with another investigational drug or other intervention during the study period * Patients on prophylactic dosing less than once every 14 days * Patients who are infused by a home nurse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Days 1-180 | % from baseline to active phase that patient adheres to using needle disposal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and provider satisfaction survey | Day 181 +/- 7 days | Patient and provider satisfaction survey |
Countries
United States
Contacts
CONTACTAllyson Pishko, MD
CONTACTKaren Panckeri, MBE
PRINCIPAL_INVESTIGATORAllyson Pishko, MD
University of Pennsylvania
Outcome results
None listed