Controlled Education Of Patients After Stroke (CEOPS)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: REGIS BORDET, MD phD
- Phone Number: +33 (0)3 20 44 54 49
- Email: regis.bordet@univ-lille2.fr
Study Locations
-
-
-
Amiens, France
- CHU Amiens Picardie
-
Besançon, France, 25000
- CHU
-
Bordeaux, France, 33076
- CHU
-
Brest, France
- CHRU Brest
-
Bron, France
- Hopital Pierre Wertheimer - HCL
-
Calais, France, 62100
- CH
-
Capinghem, France
- Samsah Ghicl Capinghem
-
Compiègne, France
- Ch Intercommunal Compiègne-Noyon - Compiegne
-
Dijon, France, 21000
- CHU
-
Grenoble, France
- Chu de Grenoble Alpes - Grenoble 9
-
Lille, France, 59037
- CHRU
-
Limoges, France
- C H U Dupuytren Limoges
-
Maubeuge, France
- Ch Sambre Avesnois Maubeuge
-
Paris, France, 75674
- Ch Saint Joseph
-
Poitiers, France
- Chu La Miletrie - Poitiers
-
Rouen, France, 76031
- CHU
-
Vandœuvre-lès-Nancy, France
- Chru Nancy - Hopitaux de Braboi
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: optimised follow-up
optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome of stroke
Time Frame: 6 months 12 months 2 years.
|
functional handicap (Rankin scale) cognitive state (MoCA scale)
|
6 months 12 months 2 years.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: REGIS BORDET, MD phD, University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2011_34
- 2012-A00473-40 (Other Identifier: ID-RCB number, ANSM)
- PHRIP 2012 - N°12-019-0306 (Other Identifier: DGOS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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