Healthy Aging in People With Epilepsy Program
HAP-E
2 other identifiers
interventional
380
1 country
1
Brief 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:
- 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
March 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
June 12, 2026
June 1, 2026
4.4 years
September 18, 2023
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (9)
Health literacy
Baseline (Week 0) and post-intervention (Month 3)
Participant's Quality of life
Baseline (Week 0) and post-intervention (Month 3)
Participant's confidence in managing different aspects of health
Baseline (Week 0) and post-intervention (Month 3)
Participant's Mood
Baseline (Week 0) and post-intervention (Month 3)
Cognitive Function
Baseline (Week 0) and post-intervention (Month 3)
- +4 more secondary outcomes
Other Outcomes (1)
Participant clinical and demographic characteristics
Baseline
Study Arms (4)
Part 1a: Patient Survey
OTHERPatients 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
OTHERProviders will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Part 3: Intervention
EXPERIMENTALParticipants 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 INTERVENTIONParticipants randomized to this group will receive standard care during their participation
Interventions
This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
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.
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anny Reyes, PhD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Staff, Principal Investigator
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
March 25, 2026
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF, ANALYTIC CODE
- Time Frame
- Beginning within the first year after study completion (August 2030) with no end date.
- 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.
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.