International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly (INR-Cap pilote)

International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study

The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).

Study Overview

• Status: Completed
• Conditions: Aged; Nursing Homes
• Intervention / Treatment: Device: CoagucheckXSR Capillary INR measures

Detailed Description

The secondary objectives of this study are to:

A. Estimate the intra-patient variability of capillary INR measures.

B. Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.

C. Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pont St Esprit, France, 30130
    • EHPAD de l'Hôpital de Pont Saint Esprit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
• The patient must be insured or beneficiary of a health insurance plan
• The patient treated with vitamin K antagonist for over six months
• The patient must have given his/her informed and signed consent
• For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent

Exclusion Criteria:

• The patient is under judicial protection
• The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
• It is impossible to correctly inform the patient, or his/her legal guardian
• The patient, or his/her legal guardian, refuses to sign the consent
• The patient is participating in another interventional study, or has participated in another interventional study within the past three months
• The patient is in an exclusion period determined by a previous study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The study population; The clinical phases of this study will be held in the nursing home (EHPAD; principal building + 2 annexes) of Pont-Saint-Esprit, located in France. Patients are elderly dependents treated by anti-vitamin K for more than 6 months.

Device: CoagucheckXSR Capillary INR measures; We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events. If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol. If capillary INR is > 4, then verification by venous measure and refer to general practitioner.; Other Names: CoagucheckXSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is the capillary INR concordant with the venous INR ? yes/no	Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of thromboembolic events per patient	6 months
The number of bleeding events per patient	6 months
The number of thromboembolic or bleeding events per patient	6 months
Coefficient of variation for capillary INR measures per patient	6 months
Time in therapeutique range (days)	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Chloé Sikirdji, Interne, Centre Hospitalier Universitaire de Nîmes; Principal Investigator: Jean-François Clape, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Aged; Aged, 80 and over; Dependent
• Other Study ID Numbers: LOCAL/2015/CS-01; 2015-A01056-43 (Other Identifier: RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO