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NCT Number: NCT06052605

Healthy Aging in People With Epilepsy Program

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).

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Anny Reyes, PhD

CONTACT

[email protected]

216-390-4266

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Aging in People with Epilepsy Program

Behavioral

This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.

patient survey

Other

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.

Provider Survey

Other

Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.

Primary outcomes

  1. Dementia Knowledge

    Time frame: 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).

  2. Acceptability of Study Program

    Time frame: Post-intervention (Month 3)

    Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program)

  3. Program Satisfaction

    Time frame: Post-intervention (Month 3)

    As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)

  4. Epilepsy Self-Management

    Time frame: 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).

  5. Attitudes about Aging

    Time frame: 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)

Secondary outcomes

  1. Health literacy

    Time frame: 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)

  2. Participant's Quality of life

    Time frame: 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").

  3. Participant's confidence in managing different aspects of health

    Time frame: 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)

  4. Participant's Mood

    Time frame: 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)

  5. Cognitive Function

    Time frame: 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)

  6. Sleep quality

    Time frame: 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.

  7. Health-promoting behaviors

    Time frame: 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.

  8. Cognitive screening

    Time frame: 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.

  9. Alcohol and smoking history

    Time frame: 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.

Other outcomes

  1. Participant clinical and demographic characteristics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anny Reyes, PhD

CONTACT

[email protected]

216-390-4266

Sponsors and collaborators

Lead sponsor

Anny Reyes

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: HAP-E

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 25, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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