NCT03212183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

August 6, 2021

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

July 5, 2017

Last Update Submit

August 2, 2021

Conditions

Keywords

web-based interventionself-managementnursingepilepsyseizures

Outcome Measures

Primary Outcomes (1)

  • Self-management

    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 Outcomes (2)

  • Acceptability of the intervention

    1 month

  • Feasibility of the intervention

    1 month

Study Arms (2)

EPI-TAVIE

EXPERIMENTAL

Patients assigned to this arm will be invited to complete a web-based nursing intervention called EPI-TAVIE.

Behavioral: EPI-TAVIE

Websites

OTHER

Patients assigned to this arm will be invited to consult a validated list of predetermined conventional websites.

Other: Websites

Interventions

EPI-TAVIEBEHAVIORAL

ÉPI-TAVIE is a web-based intervention focusing on epilepsy self-management. This interactive session (25 minutes) is facilitated by a virtual nurse.

EPI-TAVIE

The conventional websites offers reliable information about epilepsy. Their content were validated by experts.

Websites

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • having an uncontrolled psychiatric or cognitive condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José Côté, PhD

    CRCHUM, Université de Montréal

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 11, 2017

Study Start

January 22, 2018

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

August 6, 2021

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations