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

August 2, 2021 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Savoy Foundation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

September 13, 2018

Study Completion (Actual)

September 13, 2018

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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