- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07709481
Epilepsy Enhanced Care
Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
Background: Epilepsy is a common brain condition that causes repeated seizures. People with epilepsy often need a lot of information to manage their health, but many do not receive enough education about their condition. Having good health literacy (the ability to find, understand, and use health information) is important for managing epilepsy well.
Objective: This study aims to test whether a special educational program led by a trained epilepsy nurse, called "Epilepsy Enhanced Care," helps adults with epilepsy better understand and manage their health.
Study design: This is a prospective, non-randomized, controlled study involving adults (aged 18 years or older) with epilepsy. Participants will be divided into three groups:
- Intervention group: Patients with newly diagnosed epilepsy who will receive the "Epilepsy Enhanced Care" educational program in addition to their usual care.
- Control group 1: Patients with newly diagnosed epilepsy who will receive only their usual care.
- Control group 2: Patients who have had epilepsy for at least one year and will receive only their usual care.
Intervention: The "Epilepsy Enhanced Care" program is a structured, one-on-one educational session delivered by a specialized epilepsy nurse within 2 months of diagnosis. The session covers topics such as epilepsy types, medications, safety planning, and lifestyle management. Patients and their caregivers may attend together. After the session, participants can contact the nurse by phone or email with further questions.
Outcomes: The main outcome is the change in health literacy from the start of the study to 3 months after the intervention. Secondary outcomes include changes in epilepsy-specific knowledge, self-management skills, quality of life, anxiety, depression symptoms, and how often patients use healthcare services.
Study duration: Participants in the intervention group and control group 1 will be followed for 12 months. Participants in control group 2 will be assessed at a single time point. The entire study is expected to take 24 months.
Risks and benefits: The intervention involves only education and counseling, with no medications or medical devices. The risks are minimal, and participation is voluntary.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age ≥18 years;
- Confirmed epilepsy diagnosis (ILAE criteria);
- Ability to provide informed consent (or legal representative);
- Sufficient Italian proficiency.
Exclusion Criteria:
- Previous participation in a structured epilepsy education program;
- Severe untreated comorbidities precluding attendance.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Index group (newly diagnosed epilepsy + intervention)
Epilepsy Enhanced Care
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A structured, nurse-led educational program delivered by a specialized epilepsy nurse.
Includes a comprehensive consultation (within 2 months after diagnosis) covering epilepsy types, anti-seizure medications, safety planning, lifestyle management.
Caregivers encouraged to attend.
Follow-up access via telephone/email.
|
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Ingen indgriben: Control group 1 (newly diagnosed epilepsy, standard care only)
|
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Ingen indgriben: Control group 2 (established epilepsy, standard care only, cross-sectional)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement in health literacy
Tidsramme: From baseline to 3 months after enrollment
|
Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).
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From baseline to 3 months after enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in scores on other seven domains of the HLQ
Tidsramme: From baseline to 3 and 12 months after enrollment
|
For each endpoint, the change in score from baseline to follow-up will be measured in the intervention groups, and scores will be compared between the intervention and control groups at follow-up
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From baseline to 3 and 12 months after enrollment
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Change in Epilepsy-specific knowledge score
Tidsramme: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
|
|
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Change in Epilepsy Self-Management score
Tidsramme: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Change in Generalized Anxiety Disorder 7 score
Tidsramme: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Change in Neurological Disorders Depression Inventory for Epilepsy score
Tidsramme: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
|
|
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Healthcare utilization
Tidsramme: From baseline to 3 and 12 months after enrollment
|
Frequency of epilepsy-related emergency department visits, epilepsy-related hospitalizations, and unscheduled neurology consultations, collected through patient self-report and, where available, verified through electronic medical records.
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From baseline to 3 and 12 months after enrollment
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient satisfaction score
Tidsramme: At 3 months after enrollment
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At 3 months after enrollment
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CE5171
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Epilepsi
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Boston Children's HospitalRekrutteringEpilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdomForenede Stater
Kliniske forsøg med Epilepsy Enhanced Care
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Kafkas UniversityAkdeniz UniversityAfsluttetEpilepsi | Mobilapplikationer | Holdning | Viden | Selvkontrol | Intellektuelle handicap | LæreruddannelseKalkun
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Hennepin Healthcare Research InstituteAfsluttetTraumatisk hjerneskadeForenede Stater
-
University of Alabama at BirminghamAfsluttetHIV-infektioner | Opioid-relaterede lidelser | Præ-eksponeringsprofylakse (PrEP)Forenede Stater
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The Second Hospital of Shandong UniversityRekrutteringLungekræft | Kirurgi | ERASKina
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Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeVaskulær forkalkning | MammografiForenede Stater
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University Hospital of FerraraAfsluttetKolorektal kirurgi | Genoprettelse af funktion
-
David Grant U.S. Air Force Medical CenterTrukket tilbageKardiovaskulær sygdom | LungesygdomForenede Stater
-
Chi-Ming ChuDr. Chiang, Shang-lin; Dr. Liang-Cheng ChenRekrutteringHjerteoutput | Enhanced External Counterpulsation (EECP) | HjertekraftindeksTaiwan
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University of Texas Southwestern Medical CenterAfsluttet