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

Anne-Marie Mendyk, , Alain Duhamel, Yannick Bejot, Didier Leys, Laurent Derex, Olivier Dereeper, Olivier Detante, Pierre-Yves Garcia, Olivier Godefroy, Francisco Macian Montoro, Jean-Philippe Neau, Sébastien Richard, Thierry Rosolacci, Igor Sibon, Denis Sablot, Serge Timsit, Mathieu Zuber, Charlotte Cordonnier, Régis Bordet
Trials. 2018-02-22; 19(1):
DOI: 10.1186/S13063-018-2483-0

PubMed
Lire sur PubMed



1. Trials. 2018 Feb 22;19(1):137. doi: 10.1186/s13063-018-2483-0.

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.

Mendyk AM(1), Duhamel A(2), Bejot Y(3), Leys D(1), Derex L(4), Dereeper O(5),
Detante O(6), Garcia PY(7), Godefroy O(8), Montoro FM(9), Neau JP(10), Richard
S(11), Rosolacci T(12), Sibon I(13), Sablot D(14), Timsit S(15), Zuber M(16),
Cordonnier C(1), Bordet R(17); on the behalf of Strokavenir network.

Collaborators: Canaple S, Arnoux A, Barbey M, Lamy C, Blin S, Lilan L, Heyvang N,
Leroux F, Gouvenec N, Couadou F, Lemaire B, Manier E, Perez C, Seghezzi JC, Soret
H, Giroud M, Mielle N, Bodenant M, Deplanque D, Dequatre N, Hénon H, Lebeau F,
Peré C, Pommet B, Teypaz J, Desfarges N, Setnikar A, Deporter O, Monvoisin S,
Godaux S, Chatelain A, Touati B, Bonnetain A, Gimenez E, Joule J, Karl M,
Mesnildrey S, Lahanque A.

Author information:
(1)University Lille, Inserm, CHU, U1171 ‘Degenerative and vascular cognitive
disorders’, F-59000, Lille, France.
(2)University Lille, CHU, EA2694, F-59000, Lille, France.
(3)University Hospital and Medical School of Dijon, University of Burgundy,
Digon, France.
(4)Department of Stroke Medicine, Université Lyon 1, Lyon, France.
(5)Stroke Unit, Neurology Department, Calais Hospital, Calais, France.
(6)Université Grenoble Alpes, Grenoble Institut des Neurosciences, GIN, Grenoble,
France.
(7)Stroke Unit, Neurology Department, Compiègne Hospital, Compiègne, France.
(8)Department of Neurology and Functional Neuroscience Laboratory EA 4559, Amiens
University Medical Center, Amiens, France.
(9)Stroke Unit, University Hospital of Limoges, Limoges, France.
(10)Department of Neurology, CHU of Poitiers, University of Poitiers, Poitiers,
France.
(11)Stroke unit, Department of Neurology, CHU of Nancy, Lorraine University,
Nancy, France.
(12)Stroke Unit, Neurology Department, Maubeuge Hospital, Maubeuge, France.
(13)Department of Neurology, Bordeaux University Hospital, University of
Bordeaux, Bordeaux, France.
(14)Stroke Unit, Neurology Department, Perpignan Hospital, Perpignan, France.
(15)CHRU Brest, Department of Neurology and Stroke Unit, Université de Bretagne
Occidentale, Brest, France.
(16)Department of Neurology, Saint-Joseph Hospital Center, AP – HP, Université
Paris-Descartes, INSERM UMR S 919, Paris, France.
(17)University Lille, Inserm, CHU, U1171 ‘Degenerative and vascular cognitive
disorders’, F-59000, Lille, France. .

BACKGROUND: Setting up a follow-up secondary prevention program after stroke is
difficult due to motor and cognitive impairment, but necessary to prevent
recurrence and improve patients’ quality of life. To involve a referent nurse and
a caregiver from the patient’s social circle in nurse-led multimodal and
long-term management of risk factors after stroke could be an advantage due to
their easier access to the patient and family. The aim of this study is to
compare the benefit of optimized follow up by nursing personnel from the vascular
neurology department including therapeutic follow up, and an interventional
program directed to the patient and a caregiving member of their social circle,
as compared with typical follow up in order to develop a specific follow-up
program of secondary prevention of stroke.
METHODS/DESIGN: The design is a randomized, controlled, clinical trial conducted
in the French Stroke Unit of the Strokavenir network. In total, 410 patients will
be recruited and randomized in optimized follow up or usual follow up for 2
years. In both group, patients will be seen by a neurologist at 6, 12 and 24
months. The optimized follow up will include follow up by a nurse from the
vascular neurology department, including therapeutic follow up, and a training
program on secondary prevention directed to the patient and a caregiving member
of their social circle. After discharge, a monthly telephone interview, in the
first year and every 3 months in the second year, will be performed by the nurse.
At 6, 12 and 24 month, the nurse will give the patient and caregiver another
training session. Usual follow up is only done by the patient’s general
practitioner, after classical information on secondary prevention of risk factors
during hospitalization. The primary outcome measure is blood pressure measured
after the first year of follow up. Blood pressure will be measured by nursing
personnel who do not know the group into which the patient has been randomized.
Secondary endpoints are associated mortality, morbidity, recurrence, drug
side-effects and medico-economic analysis.
DISCUSSION: The result of this trial is expected to provide the benefit of a
nurse-led optimized multimodal and long-term interventional program for
management of risk factors after stroke, personalizing the role of the nurse and
including the patient’s caregiver.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT 02132364. Registered on 7 May 2014.
EUDRACT, A 00473-40.

DOI: 10.1186/s13063-018-2483-0
PMCID: PMC5824577
PMID: 29471839 [Indexed for MEDLINE]

Auteurs Bordeaux Neurocampus