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Controlled Education Of Patients After Stroke (CEOPS)

Primary Purpose

Stroke, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
optimised follow-up
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, hypertension, secondary prevention, educational program

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Amiens PicardieRecruiting
  • CHU
  • CHURecruiting
  • Chru BrestRecruiting
  • Hopital Pierre Wertheimer - HclRecruiting
  • CHRecruiting
  • Samsah Ghicl CapinghemRecruiting
  • Ch Intercommunal Compiègne-Noyon - CompiegneRecruiting
  • CHURecruiting
  • Chu de Grenoble Alpes - Grenoble 9Recruiting
  • CHRURecruiting
  • C H U Dupuytren LimogesRecruiting
  • Ch Sambre Avesnois MaubeugeRecruiting
  • Ch Saint Joseph
  • Chu La Miletrie - PoitiersRecruiting
  • CHU
  • Chru Nancy - Hopitaux de BraboiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

optimised follow-up

typical follow-up

Arm Description

optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.

no intervention

Outcomes

Primary Outcome Measures

blood pressure
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
functional handicap (Rankin scale) cognitive state (MoCA scale)

Full Information

First Posted
May 5, 2014
Last Updated
September 8, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02132364
Brief Title
Controlled Education Of Patients After Stroke
Acronym
CEOPS
Official Title
Controlled Education Of Patients After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2014 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hypertension
Keywords
stroke, hypertension, secondary prevention, educational program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
optimised follow-up
Arm Type
Other
Arm Description
optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
Arm Title
typical follow-up
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
optimised follow-up
Intervention Description
optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
Primary Outcome Measure Information:
Title
blood pressure
Description
blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomised.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Outcome of stroke
Description
functional handicap (Rankin scale) cognitive state (MoCA scale)
Time Frame
6 months 12 months 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regis BORDET, MD phD
Phone
+33 (0)3 20 44 54 49
Email
regis.bordet@univ-lille2.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
REGIS BORDET, MD phD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Godefroy, MD
Facility Name
CHU
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
THIERRY MOULIN, MDphD
Phone
+33 (0)3 01 66 84 38
Email
thierry.moulin@univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
THIERRY MOULIN, MD phD
Facility Name
CHU
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGOR SIBON, MD phD
Phone
+33(0)5 79 55 20
Email
igor.sibon@chu-bordeaux.fr
Facility Name
Chru Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT, MD
Facility Name
Hopital Pierre Wertheimer - Hcl
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent DEREX, MD
Facility Name
CH
City
Calais
ZIP/Postal Code
62100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OLIVIER DEREEPER, MD
Phone
+33 (0)3 21 46 33 33
Email
o.dereeper@ch-calais.fr
First Name & Middle Initial & Last Name & Degree
OLIVIER DEREEPER, MD
Facility Name
Samsah Ghicl Capinghem
City
Capinghem
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick HAUTECOEUR, MD
Facility Name
Ch Intercommunal Compiègne-Noyon - Compiegne
City
Compiègne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis MAS, MD
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAURICE GIROUD, MD phD
Phone
+33 (0)3 03 80 29 37 53
Email
maurice.giroud@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
MAURICE GIROUD, MD phD
Facility Name
Chu de Grenoble Alpes - Grenoble 9
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier DETANTE, MD
Facility Name
CHRU
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REGIS BORDET, MD phD
Phone
+33 (0)3 20 44 54 49
Email
regis.bordet@univ-lille2.fr
First Name & Middle Initial & Last Name & Degree
REGIS BORDET, MDphD
First Name & Middle Initial & Last Name & Degree
DIDIER LEYS, MD phdD
Facility Name
C H U Dupuytren Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco MACIAN-MONTORO, MD
Facility Name
Ch Sambre Avesnois Maubeuge
City
Maubeuge
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Rosolacci, MD
Facility Name
Ch Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MATHIEU ZUBER, MD phd
Phone
+33 (0)1 44 12 34 09
Email
m.zuber@hpsj.fr
First Name & Middle Initial & Last Name & Degree
MATHIEU ZUBER, MD phD
Facility Name
Chu La Miletrie - Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe NEAU, MD
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EVELYNE MASSARDIER, MD
Phone
+33 (0)2 32 88 87 40
Email
evelyne.massadier@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
EVELYNE MASSARDIER, MD
First Name & Middle Initial & Last Name & Degree
AUDE TRIQUENOT, MD
Facility Name
Chru Nancy - Hopitaux de Braboi
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Richard, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
PubMed Identifier
29471839
Citation
Mendyk AM, Duhamel A, Bejot Y, Leys D, Derex L, Dereeper O, Detante O, Garcia PY, Godefroy O, Montoro FM, Neau JP, Richard S, Rosolacci T, Sibon I, Sablot D, Timsit S, Zuber M, Cordonnier C, Bordet R; on the behalf of Strokavenir network. Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial. Trials. 2018 Feb 22;19(1):137. doi: 10.1186/s13063-018-2483-0.
Results Reference
derived

Learn more about this trial

Controlled Education Of Patients After Stroke

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