Clinical trial NCT04311151: Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior
Official title: Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Epilepsy; Seizure
Risk Behavior
Risk-Taking
Keywords: epilepsy, Risk-Taking, risk behavior, seizure, visualization
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2020-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline patient's perception of the severity of his or her own disease
timeFrame: five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.
measure: change from patient's habits/risk behavior
timeFrame: five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later
Secondary outcomes:
measure: baseline quality of life
timeFrame: During the hospital admission (pre visualization of self seizures)
measure: baseline severity of depressive symptoms
timeFrame: During the hospital admission (pre visualization of self seizures)
measure: anxiety trait and state
timeFrame: five minutes pre-visualization and five minutes post -visualization of self seizures
Other outcomes:
Locations:
Study officials:
affiliation: Parc de Salut Mar
name: Isabel Flores
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.