NCT04311151

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

March 10, 2020

Last Update Submit

March 14, 2020

Conditions

EpilepsyEpilepsy; SeizureRisk BehaviorRisk-Taking

Keywords

epilepsy, Risk-Taking, risk behavior, seizure, visualization

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (3)

  • baseline quality of life

    During the hospital admission (pre visualization of self seizures)

  • baseline severity of depressive symptoms

    During the hospital admission (pre visualization of self seizures)

  • anxiety trait and state

    five minutes pre-visualization and five minutes post -visualization of self seizures

Study Arms (2)

self seizures visualization group

EXPERIMENTAL

Visualization of the own epileptic seizures occured during hospital admission.

Procedure: own seizures visualization

usual management

NO INTERVENTION

Usual way management

Interventions

own seizures visualizationPROCEDURE

At the hospital discharge, patients

self seizures visualization group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26783554RESULT

  • 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.

    PMID: 21157541RESULT

  • 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.

    PMID: 26842929RESULT

MeSH Terms

Conditions

EpilepsyRisk-TakingSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Isabel Flores

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 17, 2020

Study Start

January 12, 2017

Primary Completion

May 31, 2019

Study Completion

February 1, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Not considered, since the data processing will be done on an aggregate basis.