Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior

Epilepsy Clinical Trial

— VICE  

Official title:

Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311151
• Other study ID #: CEIm-PSMAR 2016/6859/I
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: February 2020

Study information

• Verified date: March 2020
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy; Seizure
• Risk Behavior
• Risk-Taking
• Seizures

Intervention

Procedure:
• own seizures visualization
At the hospital discharge, patients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Germans Trias i Pujol Hospital

References & Publications (3)

Bradley PM, Lindsay B, Fleeman N. Care delivery and self management strategies for adults with epilepsy. Cochrane Database Syst Rev. 2016 Feb 4;2:CD006244. doi: 10.1002/14651858.CD006244.pub3. Review. — View 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. — View Citation

Serrano-Castro PJ, Mauri-Llerda JA, Hernández-Ramos FJ, Sánchez-Alvarez JC, Parejo-Carbonell B, Quiroga-Subirana P, Vázquez-Gutierrez F, Santos-Lasaosa S, Mendez-Lucena C, Redondo-Verge L, Tejero-Juste C, Morandeira-Rivas C, Sancho-Rieger J, Matías-Guiu J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.
Primary	change from patient's habits/risk behavior	conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits	five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later
Secondary	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.	During the hospital admission (pre visualization of self seizures)
Secondary	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.	During the hospital admission (pre visualization of self seizures)
Secondary	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.	five minutes pre-visualization and five minutes post -visualization of self seizures