NCT02834273

Brief Summary

The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of morbidity, disability and stroke associated mortality Under-education about stroke may prevent people from recognizing symptoms early enough to seek immediate care. The studies reported on stroke patients managed in stroke center have shown that 39-42% of patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke. The stroke patients are therefore a population at high risk for neurological events and cardiac vascular recurrence. However, no studies have evaluated the interest of the development of therapeutic workshops in stroke unit to educate patients about symptoms suggestive of stroke, risk factors and what to do in cases of stroke. Investigators assume that the setting up of a therapeutic education workshop in the stroke unit may allow a better understanding of the symptoms, risk factors and what to do following stroke. So there is a direct benefit to the patient represented by a better knowledge of stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced risk of recurrence. More generally, there is a real benefit to promote these messages to the public through the patient and his relatives

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

June 20, 2016

Last Update Submit

November 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire EPIC score

    The questionnaire score will concern knowledge of stroke risk factors, alert symptoms and what to do : 1 point by quoted risk factor, 2 points by quoted symptom and 3 by quoted conduct

    3 months

Secondary Outcomes (6)

  • Blood pressure

    12 months

  • LDL-C

    12 months

  • Body Mass Index

    12 months

  • Smoking intoxication

    12 months

  • Recurrent stroke

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Therapeutic Workshop

EXPERIMENTAL

Therapeutic Workshop (patients following therapeutic education workshops during their hospitalization)

Behavioral: stroke education workshops

Usual care

NO INTERVENTION

Interventions

Therapeutic Workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years.
  • Diagnosis of ischemic stroke;
  • Patients with back home or shorter rehabilitation;
  • Patients affiliated to a social security scheme;
  • Patients who consented to participate in writing.

You may not qualify if:

  • Patients with cognitive disorders, vigilance, aphasia.
  • Patients institutionalized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • 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

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bertrand Lapergue, MD PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 15, 2016

Study Start

June 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations