Clinical trial NCT02614573: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly
Official title: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Nursing Homes
Keywords: Dependent
Aged, 80 and over
Aged
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Is the capillary INR concordant with the venous INR ? yes/no
timeFrame: 6 months
Secondary outcomes:
measure: The number of thromboembolic events per patient
timeFrame: 6 months
measure: The number of bleeding events per patient
timeFrame: 6 months
measure: The number of thromboembolic or bleeding events per patient
timeFrame: 6 months
measure: Coefficient of variation for capillary INR measures per patient
timeFrame: 6 months
measure: Time in therapeutique range (days)
timeFrame: 6 months
Other outcomes:
Locations:
city: Pont St Esprit
country: France
facility: EHPAD de l'Hôpital de Pont Saint Esprit
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Chloé Sikirdji, Interne
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-François Clape, MD
role: PRINCIPAL_INVESTIGATOR
References: