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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.

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. regis.bordet@univ-lille2.fr.

Abstract

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.

KEYWORDS:

Family caregiver; Multimodal intervention; Nurse; Secondary prevention; Stroke

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