Sund aldring hos mennesker med epilepsi-program (HAP-E)
10. juni 2026 opdateret af: Anny Reyes
Sund aldring hos mennesker med epilepsi-program (HAP-E): At lukke hullet i epilepsibehandling
Målet med dette kliniske forsøg er at udvikle og teste et uddannelsesprogram om demens hos ældre voksne, der lever med epilepsi. De vigtigste spørgsmål, den sigter mod at besvare er:
- Kan undervisning om sund aldring, kronisk sygdomshåndtering, demens og modificerbare livsstilsdemensrisikofaktorer forbedre demensviden og sundhedskompetence blandt ældre voksne med epilepsi?
- Kan aldringsrelateret uddannelse og ressourcer forbedre livskvaliteten blandt ældre voksne med epilepsi?
Deltagerne vil:
- Gennemfør et 12-ugers gruppeuddannelsesprogram.
- Fuldfør præ- og post-programevaluering.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
380
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Anny Reyes, PhD
- Telefonnummer: 216-390-4266
- E-mail: REYESA14@ccf.org
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic
-
Kontakt:
- Anny Reyes, PhD
- Telefonnummer: 216-390-4266
- E-mail: REYESA14@ccf.org
-
-
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
Ja
Beskrivelse
Inklusionskriterier:
- Nuværende diagnose af epilepsi stillet af en neurolog, epileptolog eller internist/familielæge
- Færdighed i engelsk
Ekskluderingskriterier:
- Demens
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Part 1a: Patient Survey
Patients with receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Additionally, they will be surveyed on unmet needs in their care, availability of healthcare information and resources related to aging and dementia, and elements of the program most important to them.
|
Patients with receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Additionally, they will be surveyed on unmet needs in their care, availability of healthcare information and resources related to aging and dementia, and elements of the program most important to them.
|
|
Andet: Part 1b: Provider Survey
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
|
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
|
|
Eksperimentel: Part 3: Intervention
Participants randomized to this group will receive a 12-week group educational program (either virtual or in-person based on patient preference) providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
|
Dette er et 12-ugers gruppeuddannelsesprogram, der giver undervisning i sund aldring, kronisk sygdomshåndtering, demens og modificerbare livsstilsdemensrisikofaktorer.
|
|
Ingen indgriben: Part 3: Control
Participants randomized to this group will receive standard care during their participation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dementia Knowledge
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Dementia Knowledge Assessment Tool was designed to measure change in knowledge of dementia including dementia and its progress, support, and care.
It contains 21 true/false items (higher score indicates greater dementia knowledge).
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Acceptability of Study Program
Tidsramme: Post-intervention (Month 3)
|
Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program)
|
Post-intervention (Month 3)
|
|
Program Satisfaction
Tidsramme: Post-intervention (Month 3)
|
As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
|
Post-intervention (Month 3)
|
|
Epilepsy Self-Management
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Use of epilepsy self-management practices will be assessed with the Epilepsy Self-Management Scale (Min-Max 38-190, higher score means more frequent use of self-management strategies).
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Attitudes about Aging
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
As measured by the Attitudes about Aging questionnaire (3 subscales with Min-Max 8-40; for two subscales, higher score mean more positive attitude; and for the third subscale, higher score means more negative attitude)
|
Baseline (Week 0) and post-intervention (Month 3)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health literacy
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Assessment of participants' health literacy will be done by the Short Assessment of Health Literacy-English (Min-Max 0-18, lower number indicates lower health literacy)
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Participant's Quality of life
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
As assessed by Quality of life in Epilepsy-31 (raw scores are converted to T-scores and higher T-scores indicate better quality of life) and the Quality of Life in Neurological Disorders (Likert scale format ranging from "Never" to "Always").
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Participant's confidence in managing different aspects of health
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
As measured by the Chronic Disease Self-Efficacy Scale (contains 10 subscales where the score for each scale is the mean of the items, higher numbers indicate higher self-efficacy)
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Participant's Mood
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
As measured by Geriatric Anxiety Inventory (Min-Max 0-20, higher scores indicate greater number of reported anxiety symptoms) and Geriatric Depression Scale (Min-Max 0-15, higher score indicates more depression symptoms)
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Cognitive Function
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
As measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (raw scores are converted to scaled scores to adjust for age, higher scores indicate better performance), the Trail Making Test (measured by total time of completion with higher scores indicating poorer performance), the Test of Practical Judgment (raw scores converted to z-scores based on normative sample, lower z-scores indicating loss of everyday judgment abilities), the Everyday Cognition (scored by on four-point scale, higher total score indicates greater subjective decline in cognitive function), and the Functional Assessment Questionnaire (Min-Max 0-30, higher scores indicate greater impairment in activities of daily living)
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Sleep quality
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Measured with the Pittsburgh Sleep Quality Index (PSQI).
The PSQI measures the quality and patterns of sleep in older adults.
A global score is generated ranging from 0 to 21, with total score higher than 5 indicating "poor" sleeper.
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Health-promoting behaviors
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Health promoting behaviors will be measured with the Health-Promoting Lifestyle Profile II (HPLP-II).
The HPLP-II is a 52-item behavior rating scale employs a 4-point response format to measure the frequency of self-reported health-promoting behaviors in the domains of health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management.
A total score is generating by averaging across all 52 items with higher scores indicating higher number of health-promoting behaviors.
Six subscales are also generated by averaging across the items for each subscale.
|
Baseline (Week 0) and post-intervention (Month 3)
|
|
Cognitive screening
Tidsramme: Baseline
|
The Telephone Montreal Cognitive Assessment (T-MoCA) will be used as screening tool of cognition; the T-MoCA is a modified version of the MoCA-30 that can be administered by phone and measures global cognitive functioning.
Raw scores range from 0 to 22 with higher scores indicating better performance.
|
Baseline
|
|
Alcohol and smoking history
Tidsramme: Baseline (Week 0) and post-intervention (Month 3)
|
Information on alcohol use including frequency and types of alcohol consumed and smoking status, amount of smoking, and age at smoking cessation will also be collected.
|
Baseline (Week 0) and post-intervention (Month 3)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant clinical and demographic characteristics
Tidsramme: Baseline
|
Participant age, gender, race, ethnicity, marital status, education level, primary language, and working status/profession will be collected of all participants.
Epilepsy clinical history including age of onset, medications, seizure frequency, history and type of surgery, injury related to and seizures.
Other medical and psychiatric history including hypertension, diabetes, hyperlipidemia, mood disorders (depression, anxiety), and family history of dementia.
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anny Reyes, PhD, The Cleveland Clinic
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 (Faktiske)
25. marts 2026
Primær færdiggørelse (Anslået)
31. juli 2030
Studieafslutning (Anslået)
1. august 2030
Datoer for studieregistrering
Først indsendt
18. september 2023
Først indsendt, der opfyldte QC-kriterier
18. september 2023
Først opslået (Faktiske)
25. september 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB 25-598
- 1K23NS138682-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data to be shared will include clinical and demographic information, quantitative survey responses, self-report and cognitive assessment data, and summaries of focus group discussions with stakeholder recommendations, along with associated documentation such as codebooks and analytic materials to support interpretation and reuse.
IPD-delingstidsramme
Beginning within the first year after study completion (August 2030) with no end date.
IPD-delingsadgangskriterier
IPD and supporting information will be accessible to the general public, who will be able to obtain de-identified participant data and relevant documentation through open, unrestricted access on a public data-sharing platform.
IPD-deling Understøttende informationstype
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .