Healthy Aging in People With Epilepsy Program (HAP-E)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Healthy Aging in People with Epilepsy Program; Other: Patient Survey; Other: Provider Survey

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anny Reyes, PhD; Phone Number: 216-390-4266; Email: REYESA14@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Anny Reyes, PhD; Phone Number: 216-390-4266; Email: REYESA14@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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: Part 1b: Provider Survey; Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.	Other: Provider Survey; Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Experimental: 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.	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.
No Intervention: Part 3: Control; Participants randomized to this group will receive standard care during their participation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dementia Knowledge	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	Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program)	Post-intervention (Month 3)
Program Satisfaction	As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)	Post-intervention (Month 3)
Epilepsy Self-Management	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	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	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	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	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	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	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	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	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant clinical and demographic characteristics	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

Collaborators and Investigators

• Sponsor: Anny Reyes
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Anny Reyes, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: IRB 25-598; 1K23NS138682-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Beginning within the first year after study completion (August 2030) with no end date.
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No