Healthy Aging Program for Epilepsy

(HAP-E Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Dementia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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: * Complete a 12-week group educational program. * Complete pre- and post-program evaluation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education rather than medication changes.

Is the Healthy Aging Program for Epilepsy safe for humans?

The safety of antiepileptic drugs (AEDs) in elderly patients has been studied, showing that both older and newer AEDs can be used safely with careful selection to minimize adverse events (unwanted side effects). Special considerations are needed for elderly patients due to changes in drug absorption and the risk of drug interactions. ^{1 2 3 4 5}

How does the Healthy Aging Program for Epilepsy treatment differ from other treatments for epilepsy?

The Healthy Aging Program for Epilepsy is unique because it focuses on promoting cognitive and brain health in older adults with epilepsy, addressing risk factors for abnormal aging that are often overlooked in standard epilepsy treatments. This approach is particularly novel as it aims to protect brain health in aging individuals with chronic epilepsy, which is not typically the focus of conventional epilepsy therapies. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for older adults with epilepsy who can understand English. They should have been diagnosed by a neurologist, epileptologist, or primary care physician. People already diagnosed with dementia cannot participate.

Inclusion Criteria

Proficiency in English

I have been diagnosed with epilepsy by a specialist.

Exclusion Criteria

You have a condition that affects your memory and thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Program

Participants complete a 12-week group educational program about dementia and healthy aging

12 weeks

Weekly group sessions

Follow-up

Participants are monitored for changes in dementia knowledge, health literacy, and quality of life

4 weeks

Treatment Details

Interventions

• Healthy Aging in People with Epilepsy Program

Trial Overview The study is testing an educational program designed to teach participants about healthy aging and managing chronic diseases, focusing on dementia and lifestyle factors that could affect their quality of life.

Participant Groups

Group I: HAP-E Epilepsy Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

In a study of 309 epilepsy patients in Poland, 73.8% reported at least one adverse event (AE) while on antiepileptic drugs (AEDs), with cognitive disturbances, psychological issues, and sedation being the most common AEs.

Treatment modifications occurred in 22.3% of patients, primarily due to lack of efficacy (10.7%) and adverse events (5.2%), highlighting the need for careful monitoring of AED effectiveness and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland. Chmielewska, B., Lis, K., Rejdak, K., et al.[2022]

The study involved 52 young adults with epilepsy and mild cognitive impairment, who spent about 3 years in a residential unit aimed at improving their independence and seizure control.

At discharge, participants showed a decline in seizure frequency, and those who moved to supported housing experienced significant improvements in health-related quality of life and daily living activities, indicating that the residential program can have positive effects beyond just reducing seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A time-limited residential unit for young adults with epilepsy and mild cognitive impairment: results of a prospective pre-post-study. Endermann, M.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Epilepsy in the elderly. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Special considerations in treating the elderly patient with epilepsy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Long-term outcome after epilepsy surgery in older adults. [2018]

4. Poland pubmed.ncbi.nlm.nih.gov

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Risk factors for dementia development, frailty, and mortality in older adults with epilepsy - A population-based analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Growing old with epilepsy: the neglected issue of cognitive and brain health in aging and elder persons with chronic epilepsy. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

Comparison of new-onset and persistent epilepsy in the elderly. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Temporal lobe epilepsy in the elderly. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Epilepsy and aging. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A time-limited residential unit for young adults with epilepsy and mild cognitive impairment: results of a prospective pre-post-study. [2015]