Home Monitoring in Hemophilia a

Recruiting

• Conditions: Hemophilia a; Anticoagulant Therapy; Monitoring; Point of Care Testing; Qualitative Research

• Registration Number: NCT06702579
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semi structured interviews - identified themes on the potential impact of home monitoring in the care for patients with hemophilia A	At enrollment	Interrelated themes describing the current experiences and envisioned impact of home monitoring in hemophilia A, derived from analysis of semi-structured qualitative interviews (thematic analysis as described by Braun and Clarke (2006))

Secondary Outcome Measures

Name	Time	Method
Semi-structured interview - Themes describing the current experienced burdens and unmet needs for hemophilia A patients requiring prophylactic therapy	At enrollment	Interrelated themes describing current experienced burdens and unmet needs for hemophilia A patients requiring prophylactic therapy, derived from analysis of semi-structured qualitative interviews (thematic analysis as described by Braun and Clarke (2006))
Semi-structured interviews - Identified themes on the current experiences of patients receiving anticoagulation with coagulation home monitoring	At enrollment	Interrelated themes describing the experiences of patients receiving anticoagulation with coagulation home monitoring, derived from analysis of semi-structured qualitative interviews (thematic analysis as described by Braun and Clarke (2006))
Focus groups - Identified themes on healthcare providers' expectations regarding home monitoring in hemophilia A	At enrollment	Interrelated themes describing the expectations of healthcare providers on the impact of home monitoring in hemophilia A, derived from analysis of semi-structured qualitative interviews (thematic analysis as described by Braun and Clarke (2006))

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands