NCT02132364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

December 16, 2025

Status Verified

February 1, 2023

Enrollment Period

7.9 years

First QC Date

May 5, 2014

Last Update Submit

December 8, 2025

Conditions

Keywords

strokehypertensionsecondary preventioneducational program

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomised.

    12 months

Secondary Outcomes (1)

  • Outcome of stroke

    6 months 12 months 2 years.

Study Arms (2)

optimised follow-up

OTHER

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

Other: optimised follow-up

typical follow-up

NO INTERVENTION

no intervention

Interventions

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

optimised follow-up

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Chu Amiens Picardie

Amiens, France

Location

CHU

Besançon, 25000, France

Location

CHU

Bordeaux, 33076, France

Location

Chru Brest

Brest, France

Location

Hopital Pierre Wertheimer - Hcl

Bron, France

Location

CH

Calais, 62100, France

Location

Samsah Ghicl Capinghem

Capinghem, France

Location

Ch Intercommunal Compiègne-Noyon - Compiegne

Compiègne, France

Location

CHU

Dijon, 21000, France

Location

Chu de Grenoble Alpes - Grenoble 9

Grenoble, France

Location

CHRU

Lille, 59037, France

Location

C H U Dupuytren Limoges

Limoges, France

Location

Ch Sambre Avesnois Maubeuge

Maubeuge, France

Location

Ch Saint Joseph

Paris, 75674, France

Location

Chu La Miletrie - Poitiers

Poitiers, France

Location

CHU

Rouen, 76031, France

Location

Chru Nancy - Hopitaux de Braboi

Vandœuvre-lès-Nancy, France

Location

Related Publications (2)

  • 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.

    PMID: 29471839BACKGROUND
  • 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.

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • REGIS BORDET, MD phD

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

January 30, 2014

Primary Completion

December 16, 2021

Study Completion

December 16, 2021

Last Updated

December 16, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations