International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly
- Conditions
- AgedNursing Homes
- Registration Number
- NCT02614573
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Is the capillary INR concordant with the venous INR ? yes/no 6 months Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant
- Secondary Outcome Measures
Name Time Method Coefficient of variation for capillary INR measures per patient 6 months The number of thromboembolic or bleeding events per patient 6 months Time in therapeutique range (days) 6 months The number of thromboembolic events per patient 6 months The number of bleeding events per patient 6 months
Trial Locations
- Locations (1)
EHPAD de l'Hôpital de Pont Saint Esprit
🇫🇷Pont St Esprit, France
EHPAD de l'Hôpital de Pont Saint Esprit🇫🇷Pont St Esprit, France