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Recruiting NCT06052605

Healthy Aging in People With Epilepsy Program

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Aging in People with Epilepsy Program, Patient Survey, Provider Survey.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care

Overview

The goal of this clinical trial is to develop and test an educational program about dementia in older adults living with epilepsy. The main questions it aims to answer are: 1. Can providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors improve dementia knowledge and health literacy among older adults with epilepsy? 2. Can aging related education and resources improve quality of life among older adults with epilepsy? Participants will: * Be randomized to an intervention group or a control group. * Complete a 12-week group educational program (intervention group). * Complete pre- and post-program evaluation (intervention and control groups).

Interventions

  • Behavioral Healthy Aging in People with Epilepsy Program
    This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
  • Other 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.
  • Other Provider Survey
    Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.

Primary outcome measures

  • Dementia Knowledge [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Acceptability of Study Program [Time frame: Post-intervention (Month 3)]
  • Program Satisfaction [Time frame: Post-intervention (Month 3)]
  • Epilepsy Self-Management [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Attitudes about Aging [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
Secondary outcome measures (9)
  • Health literacy [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Participant's Quality of life [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Participant's confidence in managing different aspects of health [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Participant's Mood [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Cognitive Function [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Sleep quality [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Health-promoting behaviors [Time frame: Baseline (Week 0) and post-intervention (Month 3)]
  • Cognitive screening [Time frame: Baseline]
  • Alcohol and smoking history [Time frame: Baseline (Week 0) and post-intervention (Month 3)]

Eligibility criteria

Inclusion criteria

  • Part 1a - Patient Survey:
  • Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
  • Age 55 years or older
  • Proficiency in English (self-assessed)
  • Part 1b - Provider Survey:
  • Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy (including Epilepsy Foundation organizational leaders)
  • Part 3:
  • Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
  • Age 55 years or older (up to 90)
  • Proficiency in English (self-assessed)

Exclusion criteria

  • Part 1a:
  • Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
  • Age 90 years or older
  • Part 3:
  • Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
  • Age 90 years or older

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06052605 · IRB 25-598 · 1K23NS138682-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗