EpilepsyNCT03212183
Evaluation of a Web-based Virtual Nursing Epilepsy Self-Management Intervention
A study testing EPI-TAVIE and Websites in people with Epilepsy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- EPI-TAVIE and Websites
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2018to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- having an uncontrolled psychiatric or cognitive condition
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official title: 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.
- Conditions
- Epilepsy
- Being tested
- EPI-TAVIE, Websites
- Keywords
- web-based intervention, self-management, nursing, epilepsy, seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-TAVIEBehavioural
ÉPI-TAVIE is a web-based intervention focusing on epilepsy self-management. This interactive session (25 minutes) is facilitated by a virtual nurse.
WebsitesOther
The conventional websites offers reliable information about epilepsy. Their content were validated by experts.
| Study group | Role | What they receive |
|---|---|---|
| EPI-TAVIE | Experimental | Patients assigned to this arm will be invited to complete a web-based nursing intervention called EPI-TAVIE. Receives: Behavioral: EPI-TAVIE |
| Websites | Other | Patients assigned to this arm will be invited to consult a validated list of predetermined conventional websites. Receives: Other: Websites |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start22 Jan 2018
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Savoy Foundation
- Responsible party
- Sponsor
- Investigators
- José Côté, PhD, Principal investigator, CRCHUM, Université de MontréalDang Khoa Nguyen, PhD, Study chair, CHUM, Université de Montréal, CRCHUMLine Beaudet, PhD, Study chair, CHUM, Université de Montréal, CRCHUMYann-Gaël Guéhéneuc, PhD, Study chair, Polytechnique MontréalVanessa Léger, BScN, Study chair, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212183
- Sponsor's protocol ID
- 17.136
- Status last verified
- Jan 2018
- First submitted
- 5 Jul 2017
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33246896
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web-based Virtual Nursing Intervention to Support Self-Management Among Adults With Epilepsy: A Preliminary Study
- ClinicalTrials.gov ID
- NCT03212183
- Acronym / sponsor ID
- 17.136
- Conditions
- Epilepsy
- Keywords
- web-based intervention, self-management, nursing, epilepsy, seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Savoy Foundation
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPI-TAVIE | Experimental | Behavioral: EPI-TAVIEPatients assigned to this arm will be invited to complete a web-based nursing intervention called EPI-TAVIE. |
| Websites | Other | Other: WebsitesPatients assigned to this arm will be invited to consult a validated list of predetermined conventional websites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- having an uncontrolled psychiatric or cognitive condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-TAVIEÉPI-TAVIE is a web-based intervention focusing on epilepsy self-management. This interactive session (25 minutes) is facilitated by a virtual nurse. | Behavioural | EPI-TAVIE |
| WebsitesThe conventional websites offers reliable information about epilepsy. Their content were validated by experts. | Other | Websites |
Primary outcome
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.
2 secondary outcomes
Acceptability of the intervention
Time frame: 1 month
Feasibility of the intervention
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Results publication: PubMed 33246896Cote 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPI-TAVIE and Websites in people with Epilepsy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.