Post CVA Persistent Hypertension Caring (Hippocrate)

This study is currently recruiting participants.
Verified November 2013 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01109251
First received: March 16, 2010
Last updated: November 12, 2013
Last verified: November 2013

March 16, 2010
November 12, 2013
July 2011
January 2015   (final data collection date for primary outcome measure)
tensional auto-measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109251 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post CVA Persistent Hypertension Caring
Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures

The study HIPPOCRATE is a prospective open comparative study with a control group.

The objective of this study is to show that an optimization of the caring of non controlled hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at the follow-up visit, an education of the patient with a decision support tree for the generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better tensional control copared to the usual caring.

This study compares the usual follow up of patients seen at a visit three months following the CVA, with a optimised follow up including the tensional auto-measure, the education of the patient and the information of the generalist and the appeal to the AHT multidisciplinary visit for resistant patients, in compliance with the guidelines.

All the hypertended patients able to realise a course of tensional automeasures will be invited to realise a course of tensional auto-measures during three days preceding the visit in the neurology department.

The tensional measures will be performed according the methodology recommended by HAS.

This strategy of caring is conform to the HAS and ESH recommendations regarding the follow up of the hypertended patients.

The hospitalised patients in neurology for CVA are in all cases convocated to the follow up visit three months after the hospitalisation. The patients will be trained in the use of the TAM by the nurse of the neurology depratment before his dropout from the neurology department at the end of hospitalisation.

The systematic use of TAM will allow to identify patients presenting a AHT "white blouse", but too patients presenting masked AHT.

The visit in the neurology department will be performed by the investigators of the neurology department. At the end of this visit, two groups of patients will be identified : patients with a controlled AHT (NI), and patients with a masked or non controlled AHT (MASC + NC).

Patients presenting a controlled AHT or a "white blouse" AHT (NI) will not be randomised. But it will be proposed to them to sign a consent to acquire their agreement to realise a exploitation of their data. This will allow to caracterise better this population of patients.

Patients presenting a masked or non controlled AHT will be invited to participate to the study after signing a consent.

The collection of the consent will be done by the investigators of the neurology department.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Post CVA Hypertension
Procedure: Auto-measure of the tension by an autotensiometer

All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department.

The auto-measures will be performed according the methodology recommended by HAS.

  • Intervention group
    Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0.
    Intervention: Procedure: Auto-measure of the tension by an autotensiometer
  • Control group
    Patients presenting a non controlled AHT(persistent AHT, AHT necessiting an adaptation of the treatment by the generalist) with information of the generalist on the necessity of obtaining the tensional control according the HAS recommendations
    Intervention: Procedure: Auto-measure of the tension by an autotensiometer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patient male or female from 20 to 80 years old included.

  • ischemic or haemorragic CVA or TIA necessiting an hospitalisation or a consultation in the neurolgy department, from more than 2 months.
  • Pression ≥140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥135/85 ou 125/75 (diabetic) = non controlled AHT OR Pression < 140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥ 135/85 ou 125/75 (diabetic) = masked AHT
  • Patient agreed to participate to the study and having signed the informed consent from

Exclusion Criteria:

  • malignant AHT necessiting the urgent and specialised caring
  • Persistance of a carotids bilateral stenosis from more than 70%
  • Severe Renal Insufficiency (Creatinin Clearance estimated by the formula MDRD < 30 ml/mn)
  • CVA with major sequelae which according the judgement of the investigator will not allow to realise TAM :

    • Major Cognitive Troubles
    • Severe motor Troubles
  • Severe concomitant Pathology
  • Patient not speaking and not understanding french.
  • Contre-indications to the realisation of TAM :

    • Cardiac Arythmy
    • Obese Patients for which the circumference of the arm is > 33 cm
  • Patient refusing to go to the 3 months after hospitalisation follow up consultation.
  • Patient with no identified generalist
  • Patient refusing to sign the informed consent form.
  • Absence of affiliation to a Social system.
Both
20 Years to 80 Years
No
Not Provided
France
 
NCT01109251
Hippocrate
No
Central Hospital, Nancy, France
Central Hospital, Nancy, France
Not Provided
Not Provided
Central Hospital, Nancy, France
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP