Controlled Education Of Patients After Stroke (CEOPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Lille
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT02132364
First received: May 5, 2014
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
Stroke
Hypertension
Other: optimised follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Controlled Education Of Patients After Stroke

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomised.


Secondary Outcome Measures:
  • Outcome of stroke [ Time Frame: 6 months 12 months 2 years. ] [ Designated as safety issue: No ]
    functional handicap (Rankin scale) cognitive state (MoCA scale)


Estimated Enrollment: 800
Study Start Date: January 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet recruiting
Bordeaux, France, 33076
Contact: IGOR SIBON, MD phD    +33(0)5 79 55 20    igor.sibon@chu-bordeaux.fr   
CH Not yet 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 Not yet 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
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02132364     History of Changes
Other Study ID Numbers: 2012-A00473-40
Study First Received: May 5, 2014
Last Updated: May 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on September 22, 2014