Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Anny Reyes
- Enrollment
- 380
- Locations
- 2
- Primary Endpoint
- Health literacy
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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
- •Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
- •Age 90 years or older
- •Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
- •Age 90 years or older
Arms & Interventions
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.
Intervention: Patient Survey (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.
Intervention: Provider Survey (Other)
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.
Intervention: Healthy Aging in People with Epilepsy Program (Behavioral)
Part 3: Control
Participants randomized to this group will receive standard care during their participation
Outcomes
Primary Outcomes
Health literacy
Time Frame: Pre and Post intervention (3 months)
Short Assessment of Health Literacy-English is an 18-item scale assessing adult's ability to read and understand common medical terms.
Health Related Quality of life
Time Frame: Pre and Post intervention (3 months)
Quality of life in Epilepsy-31 is a self-report questionnaire assessing quality of life in individuals with epilepsy. It measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, physical function, pain, role limitations due to physical problems, health perception, and perceived problems with attention/concentration, language, memory.
Dementia Knowledge
Time Frame: Pre and Post intervention (3 months)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anny Reyes
Associate Staff, Principal Investigator
The Cleveland Clinic