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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03212183
Other study ID # 17.136
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2018
Est. completion date September 13, 2018

Study information

Verified date January 2018
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date September 13, 2018
Est. primary completion date September 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Centre Hospitalier de l'Université de Montréal Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM) Savoy Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Côté J, Beaudet L, Auger P, Rouleau G, Chicoine G, Léger 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). 1 month
Secondary 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. 1 month
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