Actively Recruiting
Home Monitoring in Hemophilia a
Led by Radboud University Medical Center · Updated on 2024-11-25
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: A novel point-of-care device capable of measuring factor VIII (FVIII) activity and thrombin generation (TG) is currently under development. Utilization of this device in a home situation could potentially transform hemophilia care and improve patients' autonomy. Objective: To explore the potential consequences of home monitoring of hemostatic parameters in patients with hemophilia A Study design: Cross-sectional observational study consisting of semi-structured interviews and focus groups Study population: Approximately 10 patients treated with vitamin K antagonists engaging in self-monitoring of coagulation at home and approximately 20 patients with hemophilia A. Main study parameters/endpoints: The main outcome of this study is to assess series of interrelated themes related to the unmet needs of hemophilia patients and the envisioned potential consequences of home monitoring on these unmet needs. Secondary outcomes include: identifying key features of a home monitoring platform to be used in hemophilia care, describing the experienced consequences of implementing home self-monitoring in anticoagulation treatment, assessing the current experiences of patients with self-monitoring, and providing an overview of the burdens and unmet needs experienced by patients with hemophilia with current hemophilia care. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk associated with participation in this study is negligible. Minor patients will be included in this study only if informed consent is given by both the patient and his/her caregiver (in patients between 12-16 years old). Gathering the insights of caregivers of minor patients on the current care for hemophilia and potential consequences of home self-monitoring is vital, as their experiences and needs might differ significantly from older patients. Participating in this study does not entail direct benefits. However, patients who participate can contribute to the development of future monitoring systems, which have the potential to alleviate the current burden of their disease and treatment.
CONDITIONS
Official Title
Home Monitoring in Hemophilia a
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 12 years or older or caregiver of a patient younger than 12 years
- Diagnosis of congenital hemophilia A, with or without inhibitors
- Receiving prophylactic treatment for hemophilia A
- Able to speak and understand Dutch or English without a translator
- Signed informed consent form
- For patients treated with vitamin K antagonists: aged over 16 years
- Using vitamin K antagonist for any indication
- Registered at the "Trombosezorg dichterbij"
- Self-testing INR at home for more than 3 months
- History of INR monitoring at a care facility (not self-testing)
- Hemophilia healthcare professionals with at least 3 years clinical experience in hemophilia care
- Signed informed consent form
- Able to speak and understand Dutch or English without a translator
You will not qualify if you...
- Unwilling to consent to the study or to audio recording
- No diagnosis of congenital hemophilia A (for hemophilia A patients)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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