Home Monitoring in Hemophilia a

Radboud University Medical Center

Status

Enrolling

Conditions

Qualitative Research

Point of Care Testing

Hemophilia a

Monitoring

Anticoagulant Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT06702579

HEMSTOL85

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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