NCT06702579Terminated
Home Monitoring in Hemophilia A
Qualitative Study on Home Monitoring of Hemostasis in Anticoagulant Treatment and Hemophilia A
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 19 (actual)
- First submitted
- 12 Nov 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Haemophilia
- NCT number
- NCT06702579
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of congenital hemophilia A, with or without inhibitors
- Receiving prophylactic treatment
Age
- Patients aged ≥ 12 years or caregivers of patients aged < 12 years old
- At least > 3 years clinical experience in hemophilia care
Other
- Unwilling to consent with the study or with audio recording
- Hemophilia A patients Inclusion criteria
- 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
- Signed informed consent form
- Able to speak and understand Dutch or English without a translator
Criteria the registry did not label
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.