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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02132364
Other study ID # 2011_34
Secondary ID 2012-A00473-40PH
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2014
Est. completion date July 2021

Study information

Verified date August 2020
Source University Hospital, Lille
Contact Regis BORDET, MD phD
Phone +33 (0)3 20 44 54 49
Email regis.bordet@univ-lille2.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Chu Amiens Picardie Amiens
France CHU Besancon
France CHU Bordeaux
France Chru Brest Brest
France Hopital Pierre Wertheimer - Hcl Bron
France CH Calais
France Samsah Ghicl Capinghem Capinghem
France Ch Intercommunal Compiègne-Noyon - Compiegne Compiègne
France CHU Dijon
France Chu de Grenoble Alpes - Grenoble 9 Grenoble
France CHRU Lille
France C H U Dupuytren Limoges Limoges
France Ch Sambre Avesnois Maubeuge Maubeuge
France Ch Saint Joseph Paris
France Chu La Miletrie - Poitiers Poitiers
France CHU Rouen
France Chru Nancy - Hopitaux de Braboi VandÅ“uvre-lès-Nancy

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Outcome of stroke functional handicap (Rankin scale) cognitive state (MoCA scale) 6 months 12 months 2 years.
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