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Controlled Education Of Patients After Stroke (CEOPS)

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ClinicalTrials.gov Identifier: NCT02132364
Recruitment Status : Recruiting
First Posted : May 7, 2014
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The main objective of the study is to compare the benefit of optimised follow-up by nursing personnel from the vascular neurology department, including therapeutic follow-up and an educational program directed to the patient and a caregiving member of his social circle, with that of a typical follow-up.

Condition or disease Intervention/treatment Phase
Stroke Hypertension Other: optimised follow-up Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Controlled Education Of Patients After Stroke
Actual Study Start Date : January 30, 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
optimised follow-up
optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
Other: optimised follow-up
optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
No Intervention: typical follow-up
no intervention



Primary Outcome Measures :
  1. blood pressure [ Time Frame: 12 months ]
    blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomised.


Secondary Outcome Measures :
  1. Outcome of stroke [ Time Frame: 6 months 12 months 2 years. ]
    functional handicap (Rankin scale) cognitive state (MoCA scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 60 years of age
  • Patients who have had a first stroke, transient or permanent, ischaemic or haemorrhagic, justifying hospitalisation
  • Patients with high blood pressure already treated or discovered at the time of the stroke and justifying the start of a treatment
  • Patients who have had a stroke with sequelae allowing immediate return home or justifying a stay of less than one month in rehabilitation
  • Patient having a member of his social circle who has agreed to provide follow-up for two years in association with the assigned nursing personnel in case of randomisation into the "optimised follow-up" group.

Exclusion criteria

  • Patients less than 60 years of age
  • Patients with a history of stroke
  • Patients who do not have high blood pressure discovered by a treatment prior to the stroke or by abnormal blood pressure figures during hospitalisation
  • Patients who have had a stroke causing serious sequelae, justifying an extended stay in a rehabilitation department
  • Patient who has no one in his social circle capable of working with the assigned nursing personnel, or patient living in an institution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132364


Contacts
Contact: Regis BORDET, MD phD +33 (0)3 20 44 54 49 regis.bordet@univ-lille2.fr

Locations
France
CHU Not yet recruiting
Besancon, France, 25000
Contact: THIERRY MOULIN, MDphD    +33 (0)3 01 66 84 38    thierry.moulin@univ-fcomte.fr   
Principal Investigator: THIERRY MOULIN, MD phD         
CHU Recruiting
Bordeaux, France, 33076
Contact: IGOR SIBON, MD phD    +33(0)5 79 55 20    igor.sibon@chu-bordeaux.fr   
CH Recruiting
Calais, France, 62100
Contact: OLIVIER DEREEPER, MD    +33 (0)3 21 46 33 33    o.dereeper@ch-calais.fr   
Principal Investigator: OLIVIER DEREEPER, MD         
CHU Recruiting
Dijon, France, 21000
Contact: MAURICE GIROUD, MD phD    +33 (0)3 03 80 29 37 53    maurice.giroud@chu-dijon.fr   
Principal Investigator: MAURICE GIROUD, MD phD         
CHRU Recruiting
Lille, France, 59037
Contact: REGIS BORDET, MD phD    +33 (0)3 20 44 54 49    regis.bordet@univ-lille2.fr   
Principal Investigator: REGIS BORDET, MDphD         
Sub-Investigator: DIDIER LEYS, MD phdD         
Ch Saint Joseph Not yet recruiting
Paris, France, 75674
Contact: MATHIEU ZUBER, MD phd    +33 (0)1 44 12 34 09    m.zuber@hpsj.fr   
Principal Investigator: MATHIEU ZUBER, MD phD         
CHU Not yet recruiting
Rouen, France, 76031
Contact: EVELYNE MASSARDIER, MD    +33 (0)2 32 88 87 40    evelyne.massadier@chu-rouen.fr   
Principal Investigator: EVELYNE MASSARDIER, MD         
Sub-Investigator: AUDE TRIQUENOT, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Principal Investigator: REGIS BORDET, MD phD University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02132364     History of Changes
Other Study ID Numbers: 2011_34
2012-A00473-40 ( Other Identifier: ID-RCB number, ANSM )
PHRIP 2012 - N°12-019-0306 ( Other Identifier: DGOS )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
stroke
hypertension
secondary prevention
educational program

Additional relevant MeSH terms:
Hypertension
Stroke
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases