EpilepsyHAP-ENCT06052605
Healthy Aging in People With Epilepsy Program
A study testing Healthy Aging in People with Epilepsy Program, Patient Survey and Provider Survey in people with Epilepsy, run by Anny Reyes at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Healthy Aging in People with Epilepsy Program, Patient Survey and Provider Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Anny Reyes, PhD, 216-390-4266, REYESA14@ccf.org
About this study
Official title: 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:
- 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?
- 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).
- Conditions
- Epilepsy
- Being tested
- Healthy Aging in People with Epilepsy Program, Patient Survey, Provider Survey
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Aging in People with Epilepsy ProgramBehavioural
This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
Patient SurveyOther
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 SurveyOther
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: 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. Receives: Other: Patient Survey |
| Part 1b: Provider Survey | Other | Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. Receives: Other: Provider Survey |
| Part 3: Intervention | Experimental | 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. Receives: Behavioral: Healthy Aging in People with Epilepsy Program |
| Part 3: Control | No intervention | Participants randomized to this group will receive standard care during their participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Post-intervention (Month 3)
Program Satisfaction
As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
Measured: 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).
Measured: 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)
Measured: Baseline (Week 0) and post-intervention (Month 3)
Secondary outcomes (9)
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)
Measured: 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").
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and post-intervention (Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start25 Mar 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anny Reyes
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Anny Reyes, The Cleveland Clinic
- Investigators
- Anny Reyes, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052605
- Sponsor's protocol ID
- IRB 25-598
- Other IDs
- 1K23NS138682-01A1
- Acronym
- HAP-E
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care
- ClinicalTrials.gov ID
- NCT06052605
- Acronym / sponsor ID
- HAP-E / IRB 25-598
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Anny ReyesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Patient Survey | Other | Other: Patient SurveyPatients 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. |
| Part 1b: Provider Survey | Other | Other: Provider SurveyProviders will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. |
| Part 3: Intervention | Experimental | Behavioral: Healthy Aging in People with Epilepsy ProgramParticipants 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. |
| Part 3: Control | No intervention | –Participants randomized to this group will receive standard care during their participation |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Aging in People with Epilepsy ProgramThis a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors. | Behavioural | Part 3: Intervention |
| Patient SurveyPatients 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 1a: Patient Survey |
| Provider SurveyProviders will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. | Other | Part 1b: Provider Survey |
Primary outcome
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).
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)
Program Satisfaction
Time frame: Post-intervention (Month 3)
As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
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).
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)
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anny Reyes, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Aging in People with Epilepsy Program, Patient Survey and Provider Survey in people with Epilepsy, run by Anny Reyes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anny Reyes, PhD (216-390-4266, REYESA14@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Knowledge (time frame: Baseline (Week 0) and post-intervention (Month 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.