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Patient Education Following a Stroke (EPIC)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stroke education workshops
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Workshop

Usual care

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood pressure
LDL-C
Body Mass Index
Smoking intoxication
Recurrent stroke
Compliance to treatments

Full Information

First Posted
June 20, 2016
Last Updated
November 30, 2017
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02834273
Brief Title
Patient Education Following a Stroke
Acronym
EPIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Workshop
Arm Type
Experimental
Arm Description
Therapeutic Workshop (patients following therapeutic education workshops during their hospitalization)
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
stroke education workshops
Primary Outcome Measure Information:
Title
Questionnaire EPIC score
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
12 months
Title
LDL-C
Time Frame
12 months
Title
Body Mass Index
Time Frame
12 months
Title
Smoking intoxication
Time Frame
12 months
Title
Recurrent stroke
Time Frame
12 months
Title
Compliance to treatments
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Lapergue, MD PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34813082
Citation
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.
Results Reference
derived

Learn more about this trial

Patient Education Following a Stroke

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