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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
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring epilepsy, Risk-Taking, risk behavior, seizure, visualization

Eligibility Criteria

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

Inclusion Criteria:

  1. 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.
  2. 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

    First Posted
    March 10, 2020
    Last Updated
    March 14, 2020
    Sponsor
    Parc de Salut Mar
    Collaborators
    Germans Trias i Pujol Hospital
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    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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