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Epilepsy Enhanced Care

12. juli 2026 opdateret af: Payam Tabaee Damavandi, Ente Ospedaliero Cantonale, Bellinzona

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

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

166

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: Index group (newly diagnosed epilepsy + intervention)
Epilepsy Enhanced Care
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.
Ingen indgriben: Control group 1 (newly diagnosed epilepsy, standard care only)
Ingen indgriben: Control group 2 (established epilepsy, standard care only, cross-sectional)

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).
From baseline to 3 months after enrollment

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
From baseline to 3 and 12 months after enrollment
Change in Epilepsy-specific knowledge score
Tidsramme: From baseline to 3 and 12 months after enrollment
From baseline to 3 and 12 months after enrollment
Change in Epilepsy Self-Management score
Tidsramme: From baseline to 3 and 12 months after enrollment
From baseline to 3 and 12 months after enrollment
Change in Generalized Anxiety Disorder 7 score
Tidsramme: From baseline to 3 and 12 months after enrollment
From baseline to 3 and 12 months after enrollment
Change in Neurological Disorders Depression Inventory for Epilepsy score
Tidsramme: From baseline to 3 and 12 months after enrollment
From baseline to 3 and 12 months after enrollment
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.
From baseline to 3 and 12 months after enrollment

Andre resultatmål

Resultatmål
Tidsramme
Patient satisfaction score
Tidsramme: At 3 months after enrollment
At 3 months after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

12. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CE5171

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Epilepsi

  • Boston Children's Hospital
    Rekruttering
    Epilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdom
    Forenede Stater

Kliniske forsøg med Epilepsy Enhanced Care

Abonner