Home monitoring for patients with hemophilia A
Qualitative Study on Home Monitoring of Hemostasis in Anticoagulant Treatment and Hemophilia a
This study is trying to see if a new home device that checks blood factors can help people with hemophilia A manage their condition better by understanding their needs and experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06702579 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the potential benefits of a novel point-of-care device that measures factor VIII activity and thrombin generation for patients with hemophilia A. By conducting semi-structured interviews and focus groups, the study will assess the unmet needs of hemophilia patients and the implications of home monitoring on their care. The study will involve approximately 30 participants, including patients treated with vitamin K antagonists and those with hemophilia A, to gather qualitative insights on their experiences and expectations regarding home monitoring.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 years and older diagnosed with congenital hemophilia A who are receiving prophylactic treatment.
Not a fit: Patients without a diagnosis of congenital hemophilia A or those unwilling to consent to the study may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance patient autonomy and improve the management of hemophilia A through effective home monitoring.
How similar studies have performed: While this approach is innovative, similar studies exploring home monitoring in other conditions have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients treated with vitamin K antagonists Inclusion criteria * Aged \> 16 years * Patient using vitamin K antagonist for any indication * Registered at the "Trombosezorg dichterbij" * Self-testing INR at home for \> 3 months * A history of monitoring INR at a care facility (not self-testing) * Signed informed consent form * Able to speak and understand Dutch or English without a translator Exclusion criteria • Unwilling to consent with the study or with audio recording Hemophilia A patients Inclusion criteria * Diagnosis of congenital hemophilia A, with or without inhibitors * Receiving prophylactic treatment * Patients aged ≥ 12 years or caregivers of patients aged \< 12 years old * Signed informed consent form * Able to speak and understand Dutch or English without a translator Exclusion criteria * No diagnosis of congenital hemophilia A * Unwilling to consent with the study or with audio recording Hemophilia healthcare professionals Inclusion criteria * Hematologist, hemophilia nurse, pharmacist or healthcare provider currently involved in the care for patients with hemophilia * At least \> 3 years clinical experience in hemophilia care * Signed informed consent form * Able to speak and understand Dutch or English without a translator
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.