Vitamine K Antagonist (VKA) TreatmentINRADOMNCT04117048
INR at Home Measurement by the LabPad® Point-of-care in Patients on Vitamin K Antagonist Drugs (VKA)
A study testing LabPad® point-of-care in people with Vitamine K Antagonist (VKA) Treatment and International Normalized Ratio (INR) Measure at Home, run by Medicalps at 1 site in France.
Trial summary
This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamine K Antagonist (VKA) Treatment, International Normalized Ratio (INR) Measure at Home, Thromboembolic Pathology
- What is being tested?
- LabPad® point-of-care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2019to 3 Apr 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Patient treated with VKA and without any heparin - VKA relay
- Patient able to read and understand the procedure, and able to express consent for the study
Who cannot join
- Patient treated with heparin
- Patient treated with direct oral anticoagulants (DAOs)
- Patient with antiphospholipid antibody syndrome (APA)
- Patient not available or wishing to change region within one year of inclusion
- Patient currently participating or having participated in the month preceding the inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- Persons referred to in Articles L.1121-5 to L.1121-8 of the French Public Health Law (corresponds to all protected persons: pregnant woman (verified by the dosage of β- human chorionic gonadotropin for any woman wishing to participate in the protocol and of childbearing age < 60 years), parturient, nursing woman, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Using LabPad® Point-of-care to Measure International Normalized Ratio (INR) at Home on the Patient's Follow up on VKA
This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.
Read the detailed description
The impact of the LabPad® point-of-care use by the nurse will be evaluated in the patients on vitamine K antagonist (VKA) treatment by measuring the time elapsed between the reading of the International Normalized Ratio (INR) by the LabPad® at patient's home and the validation of the biological measure, The time that the patient spends in his therapeutic range will be measured. The adverse events related to VKA will also be collected. At the end of the study, the patient will complete satisfaction and usage questionnaires about the LabPad®.
This study will be performed for 6 months.
- Conditions
- Vitamine K Antagonist (VKA) Treatment, International Normalized Ratio (INR) Measure at Home, Thromboembolic Pathology
- Being tested
- LabPad® point-of-care
- Keywords
- INR, Labpad®, VKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabPad® point-of-careDevice
All at home INR measurements will be performed by the nurse using the LabPad® point-of-care
| Study group | Role | What they receive |
|---|---|---|
| At home INR measurement with LabPad® | Experimental | All at home INR measurements will be performed with the LabPad® point-of-care Receives: Device: LabPad® point-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient follow up time, regardless of the value of the INR
Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, regardless of the value of the INR
Measured: During 6 months of use
Secondary outcomes (5)
Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)
Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, in case of INR outside the safety interval (≤1,8 or ≥5)
Measured: During 6 months of use
Time in Therapeutic Range
Measure of the time in hour that patient spends in his therapeutic range
Measured: During 6 months of use
Number of adverse events related to VKA
Collection of adverse events during patient follow-up
Measured: During 6 months of use
Patient's satisfaction about the LabPad®: Satisfaction Questionnaire
The patient will complete a Satisfaction Questionnaire at the end of the study. This is a questionnaire made by ourselves of 9 questions with 7 submissions and the total score will be into a value ranging from the worst satisfaction 7 to the best satisfaction 63.
Measured: After 6 months of use
LabPad® patient's use
The patient will complete a Questionnaire on the LabPad® use at the end of the study.
This is a scale from 0 (no use desire) to 10 (best use desire) and demographic questions to characterise the patients.
Measured: After 6 months of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start3 Oct 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamine K Antagonist (VKA) TreatmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients included benefit from at home INR measure
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicalps
- Sponsor type
- University, hospital or other
- Collaborators
- AG2R La Mondiale, AVALUN, Icadom, ORIADE NOVIALE, SIL-LAB INNOVATIONS, TASDA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117048
- Sponsor's protocol ID
- RCB 2019-A01357-50
- Acronym
- INRADOM
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2019
- Last updated
- 6 Apr 2020
- 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 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Using LabPad® Point-of-care to Measure International Normalized Ratio (INR) at Home on the Patient's Follow up on VKA
- ClinicalTrials.gov ID
- NCT04117048
- Acronym / sponsor ID
- INRADOM / RCB 2019-A01357-50
- Conditions
- Vitamine K Antagonist (VKA) Treatment, International Normalized Ratio (INR) Measure at Home, Thromboembolic Pathology
- Keywords
- INR, Labpad®, VKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- MedicalpsUniversity, hospital or other
- Collaborators
- AG2R La Mondiale, AVALUN, Icadom, ORIADE NOVIALE, SIL-LAB INNOVATIONS, TASDA
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 7 Oct 2019 (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.
This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.
Detailed description
The impact of the LabPad® point-of-care use by the nurse will be evaluated in the patients on vitamine K antagonist (VKA) treatment by measuring the time elapsed between the reading of the International Normalized Ratio (INR) by the LabPad® at patient's home and the validation of the biological measure, The time that the patient spends in his therapeutic range will be measured. The adverse events related to VKA will also be collected. At the end of the study, the patient will complete satisfaction and usage questionnaires about the LabPad®.
This study will be performed for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients included benefit from at home INR measure
| Arm | Type | Receives |
|---|---|---|
| At home INR measurement with LabPad® | Experimental | Device: LabPad® point-of-careAll at home INR measurements will be performed with the LabPad® point-of-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 18 years of age
- Patient treated with VKA and without any heparin - VKA relay
- Patient able to read and understand the procedure, and able to express consent for the study
Key exclusion criteria (6 listed)
- Patient treated with heparin
- Patient treated with direct oral anticoagulants (DAOs)
- Patient with antiphospholipid antibody syndrome (APA)
- Patient not available or wishing to change region within one year of inclusion
- Patient currently participating or having participated in the month preceding the inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabPad® point-of-careAll at home INR measurements will be performed by the nurse using the LabPad® point-of-care | Device | At home INR measurement with LabPad® |
Primary outcome
Patient follow up time, regardless of the value of the INR
Time frame: During 6 months of use
Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, regardless of the value of the INR
5 secondary outcomes
Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)
Time frame: During 6 months of use
Time in Therapeutic Range
Time frame: During 6 months of use
Number of adverse events related to VKA
Time frame: During 6 months of use
Patient's satisfaction about the LabPad®: Satisfaction Questionnaire
Time frame: After 6 months of use
LabPad® patient's use
Time frame: After 6 months of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Vitamine K Antagonist (VKA) Treatment
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Point of Care Testing INR in Antiphospholipid Syndrome
Antiphospholipid Syndrome, Vitamine K Antagonist (VKA) Treatment
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?
A study testing LabPad® point-of-care in people with Vitamine K Antagonist (VKA) Treatment and International Normalized Ratio (INR) Measure at Home, run by Medicalps at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 Apr 2020. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient follow up time, regardless of the value of the INR (time frame: During 6 months of use). 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 6 Apr 2020.