Hemophilia ANCT06702579
Home Monitoring in Hemophilia A
An observational study of Hemophilia A and Anticoagulant Therapy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A, Anticoagulant Therapy, Monitoring
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2024to 16 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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.
- Conditions
- Hemophilia A, Anticoagulant Therapy, Monitoring, Point of Care Testing, Qualitative Research
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Semi structured interviews - identified themes on the potential impact of home monitoring in the care for patients with hemophilia A
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))
Measured: At enrollment
Secondary outcomes (3)
Semi-structured interview - Themes describing the current experienced burdens and unmet needs for hemophilia A patients requiring prophylactic therapy
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))
Measured: At enrollment
Semi-structured interviews - Identified themes on the current experiences of patients receiving anticoagulation with coagulation home monitoring
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))
Measured: At enrollment
Focus groups - Identified themes on healthcare providers' expectations regarding home monitoring in hemophilia A
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))
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start30 Oct 2024
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Why it stopped: The study was discontinued due to a lack of available personnel to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702579
- Sponsor's protocol ID
- HEMSTOL85
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study on Home Monitoring of Hemostasis in Anticoagulant Treatment and Hemophilia A
- ClinicalTrials.gov ID
- NCT06702579
- Acronym / sponsor ID
- HEMSTOL85
- Conditions
- Hemophilia A, Anticoagulant Therapy, Monitoring, Point of Care Testing, Qualitative Research
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to a lack of available personnel to complete the study
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
3 secondary outcomes
Semi-structured interview - Themes describing the current experienced burdens and unmet needs for hemophilia A patients requiring prophylactic therapy
Time frame: At enrollment
Semi-structured interviews - Identified themes on the current experiences of patients receiving anticoagulation with coagulation home monitoring
Time frame: At enrollment
Focus groups - Identified themes on healthcare providers' expectations regarding home monitoring in hemophilia A
Time frame: At enrollment
Results and safety
The study was stopped early (reason given: The study was discontinued due to a lack of available personnel to complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Anticoagulant Therapy, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to a lack of available personnel to complete the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi structured interviews - identified themes on the potential impact of home monitoring in the care for patients with hemophilia A (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.