TerminatedNot Applicable

Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.

Stopped: In the absence of patients meeting the selection criteria, the study was prematurely terminated. The average number of patients on VKAs per EHPAD has fallen sharply because of the development of direct oral anticoagulants and the Covid crisis.

France45 participantsStarted 2022-11-18

Plain-language summary

This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The population corresponds to nursing homes patients treated with Vitamin K Antagonists for more than six months, because INRc cannot be used while anticoagulation treatment is being introduced. * The patient or his/her trusted-person/legal representative/tutor signed the consent form * The patient is an adult and lives in a nursing home * The patient has been on treatment with Vitamin K Antagonists for more than six months * The patient's target INR range is 2,5 \[2-3\] or 3 \[2,5-3,5\] * The patient is affiliated to a health insurance program Exclusion Criteria: * The patient is participating in a Type 1 interventional study involving human beings (Jardé law). * The patient is in an exclusion period determined by another study * The patient is under safeguard of justice. * It is not possible to give the patient (or his/her trusted-person/legal representative/tutor) informed information. * The patient has a short life expectancy (\< 1 month) * The Karnofky index is ≤ 20%

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy

Timeframe: Over 6 months

Trial details

NCT IDNCT05561244

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-13

Results submitted2026-01-23

View on ClinicalTrials.gov More Atrial Fibrillation trials