Home Monitoring in Hemophilia a

November 21, 2024 updated by: Radboud University Medical Center

Qualitative Study on Home Monitoring of Hemostasis in Anticoagulant Treatment and Hemophilia a

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The exact sample size for this study is not predetermined. Instead, patients will be selected using purposeful sampling methodology until theoretical saturation is achieved. Maximum variation in age, severity of hemophilia and received treatment will be pursued.

Three cases are included in the study:

  1. Patients registered at the "Trombosezorg dichterbij", treated with a vitamin K antagonist for any indication, currently engaging in self-testing INR at home
  2. Patients and caregivers of patients with hemophilia A, who require prophylactic therapy with a factor VIII concentrate. Hemophilia patients will be sampled from the patients receiving care from the Hemophilia Treatment Center Nijmegen Eindhoven Maastricht. If insufficient patients can be included from this population to achieve data saturation, additional patients will be sampled via the patient society
  3. HCPs involved in the treatment of hemophilia patients and technical experts to provide additional context.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients receiving anticoagulation therapy
Adult patients on anticoagulation therapy who perform INR self-testing at home.
Hemophilia A
Patients over 12 years old with congenital hemophilia A receiving prophylactic therapy.
Healthcare professionals
Hematologists, hemophilia nurses, pharmacists or other healthcare providers currently involved in the care for patients with hemophilia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi structured interviews - identified themes on the potential impact of home monitoring in the care for patients with hemophilia A
Time Frame: 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))
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured interview - Themes describing the current experienced burdens and unmet needs for hemophilia A patients requiring prophylactic therapy
Time Frame: 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))
At enrollment
Semi-structured interviews - Identified themes on the current experiences of patients receiving anticoagulation with coagulation home monitoring
Time Frame: 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))
At enrollment
Focus groups - Identified themes on healthcare providers' expectations regarding home monitoring in hemophilia A
Time Frame: 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))
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMSTOL85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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