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

Overview

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.

Full Title of Study: “Evaluation of a Web-based Virtual Nursing Intervention to Support Self-Management Among Adults With Epilepsy: A Preliminary Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 13, 2018

Interventions

  • 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.
  • Other: Websites
    • The conventional websites offers reliable information about epilepsy. Their content were validated by experts.

Arms, Groups and Cohorts

  • Experimental: EPI-TAVIE
    • Patients assigned to this arm will be invited to complete a web-based nursing intervention called EPI-TAVIE.
  • Other: Websites
    • Patients assigned to this arm will be invited to consult a validated list of predetermined conventional websites.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Collaborator
    • Savoy Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • José Côté, PhD, Principal Investigator, CRCHUM, Université de Montréal
    • Dang Khoa Nguyen, PhD, Study Chair, CHUM, Université de Montréal, CRCHUM
    • Line Beaudet, PhD, Study Chair, CHUM, Université de Montréal, CRCHUM
    • Yann-Gaël Guéhéneuc, PhD, Study Chair, Polytechnique Montréal
    • Vanessa Léger, BScN, Study Chair, CHUM

Citations Reporting on Results

Cote J, Beaudet L, Auger P, Rouleau G, Chicoine G, Leger V, Keezer M, Reid MA, Nguyen DK. Evaluation of a web-based virtual nursing intervention to support self-management among adults with epilepsy: A mixed-methods study. Epilepsy Behav. 2021 Jan;114(Pt A):107581. doi: 10.1016/j.yebeh.2020.107581. Epub 2020 Nov 25.

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