Epilepsy Nervous System Diseases Epilepsy
Conditions
Interventions
This is a cross-sectional validation study in PwE, with a comparator group of volunteers not affected by epilepsy. The study will be conducted in a staggered design with two phases:
Phase 1. 75 PwE a
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 15 years and above 2. Signed informed consent 3. Able to understand and respond to questionnaires 4. For PwE: definite clinical diagnosis of epilepsy established by treating physician 5. For volunteers: in case of the presence of a chronic condition such as asthma or hypertension, adequate treatment is actively used with complete control of the condition 6. Willing to perform a retest assessment if randomly selected
Exclusion criteria
Exclusion criteria: 1. Presence of a condition leading to the inability to write or speak 2. Subject currently enrolled in a clinical trial involving the use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period following recent trial involvement 3. For volunteers: the presence of any acute infectious disease or the sequelae thereof 4. For volunteers: the presence of any chronic condition resulting in current disability or presence of a neoplastic disorder 5. For volunteers: the presence of any previous trauma resulting in a current disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures will be recorded at a single timepoint (i.e. at baseline) for all subjects and at 10 days after baseline in a randomized retest sample: Construct validity: 1. Model parameters measured by factor loading range, and the Average Variance Extracted, the latter with a cut-off >0.5 2. Confirmatory fit analyses analyzed with Chi-square fit (?2 and p-value; p0.95) 3. Criterion validity analyzed by Pearson’s correlation; coefficients between item and its domain and among all domains (no cut-off) 4. Discriminatory validity measured by comparing patients with epilepsy to volunteers and by comparing high/low seizure frequency at baseline, presence of depression 5. External validity performed through comparison between scales Reliability: 1. Internal consistency measured by Cronbach’s alpha (>0.7), and Composite Reliability (>0.7) 2. Temporal stability measured by intra-class correlation (ICC) between the scores at two timepoints separated by 10 days (0,8 [good]; 0,9 [exceptional]) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SSE factor model will be analyzed using model parameters and confirmatory fit analyses on a single timepoint measurement (i.e. at baseline) 2. Ceiling effects will be measured by analysis of variance (ANOVA) on a single timepoint measurement (i.e. at baseline) 3. The possible relationship between epilepsy, its resulting disability, depression, stigma, and self-esteem using the psychosocial model described by Trani, applied to PwE and healthy volunteers, will be based on a single timepoint measurement (i.e. at baseline) and analyzed using: 3.1. Propensity score matching to correct for differences between subjects with and without disability 3.2. Structural equation models using the maximum likelihood procedure ?2 test as well as the comparative fit index (CFI significant for >0.95), the root mean square error of approximation (RMSEA significant at 0.95) | — |
Countries
Rwanda, Saint Helena
Outcome results
None listed