Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)
Primary Purpose
Epilepsy, Epilepsy; Seizure, Risk Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
own seizures visualization
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring epilepsy, Risk-Taking, risk behavior, seizure, visualization
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
self seizures visualization group
usual management
Arm Description
Visualization of the own epileptic seizures occured during hospital admission.
Usual way management
Outcomes
Primary Outcome Measures
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).
change from patient's habits/risk behavior
conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04311151
First Posted
March 10, 2020
Last Updated
March 14, 2020
Sponsor
Parc de Salut Mar
Collaborators
Germans Trias i Pujol Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04311151
Brief Title
Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior
Acronym
VICE
Official Title
Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Germans Trias i Pujol Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Epilepsy; Seizure, Risk Behavior, Risk-Taking
Keywords
epilepsy, Risk-Taking, risk behavior, seizure, visualization
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self seizures visualization group
Arm Type
Experimental
Arm Description
Visualization of the own epileptic seizures occured during hospital admission.
Arm Title
usual management
Arm Type
No Intervention
Arm Description
Usual way management
Intervention Type
Procedure
Intervention Name(s)
own seizures visualization
Intervention Description
At the hospital discharge, patients
Primary Outcome Measure Information:
Title
change from baseline patient's perception of the severity of his or her own disease
Description
self reported perceived severity of the disease through a visual analog scale (VAS).
Time Frame
five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.
Title
change from patient's habits/risk behavior
Description
conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits
Time Frame
five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later
Secondary Outcome Measure Information:
Title
baseline quality of life
Description
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.
Time Frame
During the hospital admission (pre visualization of self seizures)
Title
baseline severity of depressive symptoms
Description
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.
Time Frame
During the hospital admission (pre visualization of self seizures)
Title
anxiety trait and state
Description
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.
Time Frame
five minutes pre-visualization and five minutes post -visualization of self seizures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Flores
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not considered, since the data processing will be done on an aggregate basis.
Citations:
PubMed Identifier
26783554
Citation
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.
Results Reference
result
PubMed Identifier
21157541
Citation
Herman 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 Reference
result
PubMed Identifier
26842929
Citation
Bradley 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.
Results Reference
result
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Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior
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