EpilepsyVICENCT04311151
Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior
A study testing own seizures visualization in people with Epilepsy and Epilepsy; Seizure, run by Parc de Salut Mar.
Trial summary
In Spain, an estimated 690,000 persons have epilepsy, of whom 270,000 have active epilepsy (defined as those who have had a seizure in the last 5 years). It is estimated that 30% of patients diagnosed with epilepsy are drug-resistant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Epilepsy; Seizure, Risk Behavior
- What is being tested?
- own seizures visualization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2017to Feb 2020
- 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
- for the control group: patients aged 18 years or older admitted to the Epilepsy Unit of Hospital del Mar who voluntarily accept to participate in the study after prior psychological assessment.
- for the control group: patients admitted to the Epilepsy Unit of Hospital Germans Tries who voluntarily accept to participate in the study.
Who cannot join
- Patients with no risk behavior according to the ad hoc questionnaire administered on admission.
- Cognitive impairment preventing adequate comprehension of the study.
- Vision-impaired patients and those with language barriers.
About this study
Official title: Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)
In Spain, an estimated 690,000 persons have epilepsy, of whom 270,000 have active epilepsy (defined as those who have had a seizure in the last 5 years). It is estimated that 30% of patients diagnosed with epilepsy are drug-resistant. Patients with loss of consciousness or impaired awareness during seizures are at higher risk of injury due to accidents. To prevent such injuries, it is important that patients are sufficiently knowledgeable about their disease to allow them to avoid risk behavior.
In this project, we want to know if visualization of self seizures has an impact on the perception of the severity of the disease, as well as on the risky behavior habits.
Read the detailed description
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Main aims:
To determine whether self-visualization of seizures in patients with epilepsy modifies risk perception compared with patients not viewing their own seizures.
To determine whether viewing their seizures leads patients with epilepsy to plan changes in their risk behavior compared with patients not viewing their own seizures.
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Sample size: Accepting an alpha risk of 0.05 and a beta risk lower than 0.2 on bilateral comparison, 50 participants will be needed in the intervention group and 25 in the control group to detect statistically significant differences between the proportion of patients showing behavioral change. It is expected that behavioral change will occur in 40% of the intervention group and 10% of the control group and that losses to follow-up will be 10%.
Variables: Sociodemographic, risk perception, intention to change behavior, perception of disease severity, quality of life, mood/depression, personality traits, anxiety.
Data collection: pre and post visualization of self seizures, and three months after discharge.
A descriptive analysis will be performed, with percentages and frequencies for qualitative variables and mean ± standard deviation (or median [range] depending on the normality of the distribution) for quantitative variables. Inferential analysis will be conducted with the chi-square test or nonparametric tests depending on the behavior of the variables obtained.
This project has been approved by the Clinical Research Ethics Committee of the hospital performing the study.
- Conditions
- Epilepsy, Epilepsy; Seizure, Risk Behavior, Risk-Taking
- Being tested
- own seizures visualization
- Keywords
- epilepsy, Risk-Taking, risk behavior, seizure, visualization
- Medical subject headings
- Epilepsy, Risk-Taking, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
own seizures visualizationProcedure or surgery
At the hospital discharge, patients
| Study group | Role | What they receive |
|---|---|---|
| self seizures visualization group | Experimental | Visualization of the own epileptic seizures occured during hospital admission. Receives: Procedure: own seizures visualization |
| usual management | No intervention | Usual way management |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline patient's perception of the severity of his or her own disease
self reported perceived severity of the disease through a visual analog scale (VAS).
Measured: five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.
change from patient's habits/risk behavior
conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits
Measured: five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later
Secondary outcomes (3)
baseline quality of life
measure of the quality of life specifically in patients with epilepsy, through the Quality of Life in Epilepsy Inventory-10(QUOLIE-10), validated spanish version. This inventory ranges from 10 to 50. The higher the score, the worse quality of life.
Measured: During the hospital admission (pre visualization of self seizures)
baseline severity of depressive symptoms
self reported severity of depressive symptoms through the Beck Depression Inventory Second Edition (BDI-II), validated spanish version. This inventory ranges from 0 to 63. The higher the score, the highest severity of depressive symptoms.
Measured: During the hospital admission (pre visualization of self seizures)
anxiety trait and state
self reported anxiety trait and state through the State-Trait Anxiety Inventory-STAI, validated spanish version. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
This is a two part questionnaire. The state part will be reported five minutes pre and post visualization of self seizures, while the trait part will be reported only five minutes pre visualization.
Measured: five minutes pre-visualization and five minutes post -visualization of self seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start12 Jan 2017
- Primary completion31 May 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Principal investigator, Isabel Flores, Parc de Salut Mar
- Investigators
- Isabel Flores, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311151
- Sponsor's protocol ID
- CEIm-PSMAR 2016/6859/I
- Acronym
- VICE
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not considered, since the data processing will be done on an aggregate basis.
Publications
Serrano-Castro PJ, Mauri-Llerda JA, Hernandez-Ramos FJ, Sanchez-Alvarez JC, Parejo-Carbonell B, Quiroga-Subirana P, Vazquez-Gutierrez F, Santos-Lasaosa S, Mendez-Lucena C, Redondo-Verge L, Tejero-Juste C, Morandeira-Rivas C, Sancho-Rieger J, Matias-Guiu J. Adult Prevalence of Epilepsy in Spain: EPIBERIA, a Population-Based Study. ScientificWorldJournal. 2015;2015:602710. doi: 10.1155/2015/602710. Epub 2015 Dec 10.
PubMed 26783554Herman S. Intractable epilepsy: relapsing, remitting, or progressive? Epilepsy Curr. 2010 Nov;10(6):146-8. doi: 10.1111/j.1535-7511.2010.01383.x. No abstract available.
PubMed 21157541Bradley PM, Lindsay B, Fleeman N. Care delivery and self management strategies for adults with epilepsy. Cochrane Database Syst Rev. 2016 Feb 4;2(2):CD006244. doi: 10.1002/14651858.CD006244.pub3.
PubMed 26842929
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)
- ClinicalTrials.gov ID
- NCT04311151
- Acronym / sponsor ID
- VICE / CEIm-PSMAR 2016/6859/I
- Conditions
- Epilepsy, Epilepsy; Seizure, Risk Behavior, Risk-Taking
- Keywords
- epilepsy, Risk-Taking, risk behavior, seizure, visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 17 Mar 2020 (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.
In Spain, an estimated 690,000 persons have epilepsy, of whom 270,000 have active epilepsy (defined as those who have had a seizure in the last 5 years). It is estimated that 30% of patients diagnosed with epilepsy are drug-resistant. Patients with loss of consciousness or impaired awareness during seizures are at higher risk of injury due to accidents. To prevent such injuries, it is important that patients are sufficiently knowledgeable about their disease to allow them to avoid risk behavior.
In this project, we want to know if visualization of self seizures has an impact on the perception of the severity of the disease, as well as on the risky behavior habits.
Detailed description
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Main aims:
To determine whether self-visualization of seizures in patients with epilepsy modifies risk perception compared with patients not viewing their own seizures.
To determine whether viewing their seizures leads patients with epilepsy to plan changes in their risk behavior compared with patients not viewing their own seizures.
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Sample size: Accepting an alpha risk of 0.05 and a beta risk lower than 0.2 on bilateral comparison, 50 participants will be needed in the intervention group and 25 in the control group to detect statistically significant differences between the proportion of patients showing behavioral change. It is expected that behavioral change will occur in 40% of the intervention group and 10% of the control group and that losses to follow-up will be 10%.
Variables: Sociodemographic, risk perception, intention to change behavior, perception of disease severity, quality of life, mood/depression, personality traits, anxiety.
Data collection: pre and post visualization of self seizures, and three months after discharge.
A descriptive analysis will be performed, with percentages and frequencies for qualitative variables and mean ± standard deviation (or median [range] depending on the normality of the distribution) for quantitative variables. Inferential analysis will be conducted with the chi-square test or nonparametric tests depending on the behavior of the variables obtained.
This project has been approved by the Clinical Research Ethics Committee of the hospital performing the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self seizures visualization group | Experimental | Procedure: own seizures visualizationVisualization of the own epileptic seizures occured during hospital admission. |
| usual management | No intervention | –Usual way management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- for the control group: patients aged 18 years or older admitted to the Epilepsy Unit of Hospital del Mar who voluntarily accept to participate in the study after prior psychological assessment.
- for the control group: patients admitted to the Epilepsy Unit of Hospital Germans Tries who voluntarily accept to participate in the study.
Key exclusion criteria (3 listed)
- Patients with no risk behavior according to the ad hoc questionnaire administered on admission.
- Cognitive impairment preventing adequate comprehension of the study.
- Vision-impaired patients and those with language barriers.
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 |
|---|---|---|
| own seizures visualizationAt the hospital discharge, patients | Procedure or surgery | self seizures visualization group |
Primary outcome
change from baseline patient's perception of the severity of his or her own disease
Time frame: five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.
self reported perceived severity of the disease through a visual analog scale (VAS).
change from patient's habits/risk behavior
Time frame: five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later
conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits
3 secondary outcomes
baseline quality of life
Time frame: During the hospital admission (pre visualization of self seizures)
baseline severity of depressive symptoms
Time frame: During the hospital admission (pre visualization of self seizures)
anxiety trait and state
Time frame: five minutes pre-visualization and five minutes post -visualization of self seizures
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 17 Mar 2020.
- Results publication: PubMed 26783554Serrano-Castro PJ, Mauri-Llerda JA, Hernandez-Ramos FJ, Sanchez-Alvarez JC, Parejo-Carbonell B, Quiroga-Subirana P, Vazquez-Gutierrez F, Santos-Lasaosa S, Mendez-Lucena C, Redondo-Verge L, Tejero-Juste C, Morandeira-Rivas C, Sancho-Rieger J, Matias-Guiu J. Adult Prevalence of Epilepsy in Spain: EPIBERIA, a Population-Based Study. ScientificWorldJournal. 2015;2015:602710. doi: 10.1155/2015/602710. Epub 2015 Dec 10.
- Results publication: PubMed 21157541Herman S. Intractable epilepsy: relapsing, remitting, or progressive? Epilepsy Curr. 2010 Nov;10(6):146-8. doi: 10.1111/j.1535-7511.2010.01383.x. No abstract available.
- Results publication: PubMed 26842929Bradley PM, Lindsay B, Fleeman N. Care delivery and self management strategies for adults with epilepsy. Cochrane Database Syst Rev. 2016 Feb 4;2(2):CD006244. doi: 10.1002/14651858.CD006244.pub3.
- Individual participant dataSharing planned: No. Not considered, since the data processing will be done on an aggregate basis.
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Isabel Flores principal investigator
Parc de Salut Mar
Questions about this trial
What is this clinical trial studying?
A study testing own seizures visualization in people with Epilepsy and Epilepsy; Seizure, run by Parc de Salut Mar.
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 2 inclusion and 3 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
change from baseline patient's perception of the severity of his or her own disease (time frame: five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.). The study lists 2 primary outcomes in all. 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 NCT04311151, which also lists 3 linked publications.
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 17 Mar 2020.