Actively Recruiting
Qualitative Study on Home Monitoring of Hemostasis in Anticoagulant Treatment and Hemophilia A
Led by Radboud University Medical Center · Updated on 2024-11-25
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the potential effects of home monitoring of blood clotting factors in patients with hemophilia A and those on anticoagulant therapy. This observational, cross-sectional study aims to gather insights into the unmet needs of these patients and how home monitoring could impact their care and independence. The study also involves healthcare providers to understand their expectations of home monitoring in hemophilia care. The study includes semi-structured interviews and focus groups involving about 10 patients on vitamin K antagonists who self-monitor coagulation at home, approximately 20 patients with hemophilia A receiving prophylactic treatment, and healthcare professionals experienced in hemophilia care. Participants will share their experiences with current treatment and self-monitoring, and discuss key features for a home monitoring platform. The study does not involve any investigational treatments or interventions. Participants will engage in interviews and focus groups at enrollment to discuss their experiences and expectations regarding home monitoring. Researchers will assess themes related to burdens, unmet needs, and consequences of home self-monitoring. The study aims to identify how home monitoring might improve patient autonomy and care quality. There are minimal risks associated with participation, and minor patients require consent from both themselves and their caregivers. The study is expected to conclude by November 2025.
CONDITIONS
Brief Title
Home Monitoring in Hemophilia a
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 16 years using vitamin K antagonists for any reason
- Patients self-testing INR at home for more than 3 months
- Patients with congenital hemophilia A, with or without inhibitors, receiving prophylactic treatment
- Patients aged 12 years or older or caregivers of patients younger than 12 years
- Healthcare providers such as hematologists, hemophilia nurses, or pharmacists involved in hemophilia care with over 3 years of experience
- Signed informed consent form
- Ability to speak and understand Dutch or English without a translator
You will not qualify if you...
- Unwillingness to consent to the study or to audio recording
- No diagnosis of congenital hemophilia A for hemophilia patient group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - At enrollment
Participants complete semi-structured interviews and focus groups to share their experiences and expectations regarding home monitoring in hemophilia A and anticoagulation treatment.
1 visit (in-person or remote) for interviews and focus groups
Duration - Ongoing during study participation until completion
Participants who perform home monitoring of hemostasis are observed to identify themes related to home monitoring impact and unmet needs.
No additional visits required; observations based on participant home monitoring activities
Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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