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Evaluation of a Web-based Virtual Nursing Epilepsy Self-Management Intervention

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ClinicalTrials.gov Identifier: NCT03212183
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Savoy Foundation
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
The purpose of this pilot randomized controlled trial is to evaluate a web-based virtual nursing intervention (ÉPI-TAVIE) in terms of 1) acceptability and feasibility, and; 2) preliminary efficacy.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: EPI-TAVIE Other: Websites Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Web-based Virtual Nursing Intervention to Support Self-Management Among Adults With Epilepsy: A Preliminary Study
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: EPI-TAVIE
Patients assigned to this arm will be invited to complete a web-based nursing intervention called EPI-TAVIE.
Behavioral: EPI-TAVIE
ÉPI-TAVIE is a web-based intervention focusing on epilepsy self-management. This interactive session (25 minutes) is facilitated by a virtual nurse.

Websites
Patients assigned to this arm will be invited to consult a validated list of predetermined conventional websites.
Other: Websites
The conventional websites offers reliable information about epilepsy. Their content were validated by experts.




Primary Outcome Measures :
  1. Self-management [ Time Frame: 3 months ]
    Self-management will be measured with the Epilepsy Self-Management Scale (Dilorio et al., 1994). The scale is composed of 38 items that assess the degree to which people perform tasks to manage their epilepsy. It is composed of five subscales: medication management, information management, seizure management, safety management and lifestyle management.


Secondary Outcome Measures :
  1. Acceptability of the intervention [ Time Frame: 1 month ]
    Acceptability will be evaluated through a self-administered questionnaire composed of items regarding satisfaction with the approach, convenience of use, ease of understanding, relevance, dosage and overall appreciation (Côté et al., 2012).

  2. Feasibility of the intervention [ Time Frame: 1 month ]
    Feasibility will be assessed by an evaluation of exposition to intervention: for each participants, the number of page viewed will be recorded. Fidelity to the intervention structure will be obtained by comparing the projected number of pages view to the number of viewed pages, thus addressing its feasibility.



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

Inclusion Criteria:

  • to be a patient of the Clinique d'épilepsie du Centre Hospitalier de l'Université de Montréal
  • to be able to read and understand French
  • to have access to the Internet

Exclusion Criteria:

  • having an uncontrolled psychiatric or cognitive condition

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): NCT03212183


Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Savoy Foundation
Investigators
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Principal Investigator: José Côté, PhD CRCHUM, Université de Montréal
Study Chair: Dang Khoa Nguyen, PhD CHUM, Université de Montréal, CRCHUM
Study Chair: Line Beaudet, PhD CHUM, Université de Montréal, CRCHUM
Study Chair: Yann-Gaël Guéhéneuc, PhD Polytechnique Montréal
Study Chair: Vanessa Léger, BScN CHUM

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03212183     History of Changes
Other Study ID Numbers: 17.136
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
web-based intervention
self-management
nursing
epilepsy
seizures

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases