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Patient Education Following a Stroke (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02834273
First Posted: July 15, 2016
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose

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


Condition Intervention
Stroke Behavioral: stroke education workshops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Patient Education Following a Stroke on Knowledge of Risk Factors, Stroke Warning Signs and What to do in Cases of Stroke

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Questionnaire EPIC score [ Time Frame: 3 months ]

    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



Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 12 months ]
  • LDL-C [ Time Frame: 12 months ]
  • Body Mass Index [ Time Frame: 12 months ]
  • Smoking intoxication [ Time Frame: 12 months ]
  • Recurrent stroke [ Time Frame: 12 months ]
  • Compliance to treatments [ Time Frame: 12 months ]

Enrollment: 199
Study Start Date: June 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Workshop
Therapeutic Workshop (patients following therapeutic education workshops during their hospitalization)
Behavioral: stroke education workshops
No Intervention: Usual care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with cognitive disorders, vigilance, aphasia.
  • Patients institutionalized.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834273


Locations
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Bertrand Lapergue, MD PhD Hopital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02834273     History of Changes
Other Study ID Numbers: 2013/18
First Submitted: June 20, 2016
First Posted: July 15, 2016
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases