Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-10-30
2025-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Patients receiving anticoagulation therapy
Adult patients on anticoagulation therapy who perform INR self-testing at home.
No interventions assigned to this group
Hemophilia A
Patients over 12 years old with congenital hemophilia A receiving prophylactic therapy.
No interventions assigned to this group
Healthcare professionals
Hematologists, hemophilia nurses, pharmacists or other healthcare providers currently involved in the care for patients with hemophilia.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
Exclusion Criteria
* No diagnosis of congenital hemophilia A
* Unwilling to consent with the study or with audio recording
12 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Facility Contacts
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Other Identifiers
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HEMSTOL85
Identifier Type: -
Identifier Source: org_study_id
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