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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

EPI-TAVIE

Websites

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring web-based intervention, self-management, nursing, epilepsy, seizures

Eligibility Criteria

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

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

Sites / Locations

Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EPI-TAVIE

Websites

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability of the intervention

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

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.

Full Information

NCT ID

NCT03212183

First Posted

July 5, 2017

Last Updated

August 2, 2021

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Savoy Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03212183

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 22, 2018 (Actual)

Primary Completion Date

September 13, 2018 (Actual)

Study Completion Date

September 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Savoy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Epilepsy

Keywords

web-based intervention, self-management, nursing, epilepsy, seizures

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EPI-TAVIE

Arm Type

Experimental

Arm Description

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

Arm Title

Websites

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

EPI-TAVIE

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Websites

Intervention Description

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

Primary Outcome Measure Information:

Title

Self-management

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Acceptability of the intervention

Description

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).

Time Frame

1 month

Title

Feasibility of the intervention

Description

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.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: