NCT06052605

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:

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress37%
Aug 2024Jun 2029

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

September 18, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Pre and Post intervention (3 months)

  • Health literacy

    Short Assessment of Health Literacy-English is an 18-item scale assessing adult's ability to read and understand common medical terms.

    Pre and Post intervention (3 months)

  • Health Related Quality of life

    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.

    Pre and Post intervention (3 months)

Study Arms (1)

HAP-E Epilepsy Participants

EXPERIMENTAL
Behavioral: Healthy Aging in People with Epilepsy Program

Interventions

This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.

HAP-E Epilepsy Participants

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
  • Proficiency in English

You may not qualify if:

  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Califonia, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

August 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

June 1, 2029

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations