TerminatedNot Applicable

Home Monitoring in Hemophilia A

Stopped: The study was discontinued due to a lack of available personnel to complete the study

Netherlands19 participantsStarted 2024-10-30

Plain-language summary

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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Semi structured interviews - identified themes on the potential impact of home monitoring in the care for patients with hemophilia A

Timeframe: At enrollment

Trial details

NCT IDNCT06702579

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-16

View on ClinicalTrials.gov More Hemophilia A trials