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Controlled Education Of Patients After Stroke (CEOPS)

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ClinicalTrials.gov Identifier: NCT02132364
Recruitment Status : Recruiting
First Posted : May 7, 2014
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

May 5, 2014
May 7, 2014
April 24, 2018
January 30, 2014
July 2021   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02132364 on ClinicalTrials.gov Archive Site
Outcome of stroke [ Time Frame: 6 months 12 months 2 years. ]
functional handicap (Rankin scale) cognitive state (MoCA scale)
Same as current
Not Provided
Not Provided
 
Controlled Education Of Patients After Stroke
Controlled Education Of Patients After Stroke
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Hypertension
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
    optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
    Intervention: Other: optimised follow-up
  • No Intervention: typical follow-up
    no intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
Same as current
July 2021
July 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 90 Years   (Adult, Older Adult)
No
Contact: Regis BORDET, MD phD +33 (0)3 20 44 54 49 regis.bordet@univ-lille2.fr
France
 
 
NCT02132364
2011_34
2012-A00473-40 ( Other Identifier: ID-RCB number, ANSM )
PHRIP 2012 - N°12-019-0306 ( Other Identifier: DGOS )
No
Not Provided
Plan to Share IPD: No
University Hospital, Lille
University Hospital, Lille
Ministry of Health, France
Principal Investigator: REGIS BORDET, MD phD University Hospital
University Hospital, Lille
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP