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Healthy Aging in People With Epilepsy Program (HAP-E)

Primary Purpose

Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Aging in People with Epilepsy Program
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician Proficiency in English Exclusion Criteria: Dementia

Sites / Locations

  • University of Califonia, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAP-E Epilepsy Participants

Arm Description

Outcomes

Primary Outcome Measures

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.
Health literacy
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT06052605
Brief Title
Healthy Aging in People With Epilepsy Program
Acronym
HAP-E
Official Title
Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAP-E Epilepsy Participants
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Healthy Aging in People with Epilepsy Program
Intervention Description
This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
Primary Outcome Measure Information:
Title
Dementia Knowledge
Description
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.
Time Frame
Pre and Post intervention (3 months)
Title
Health literacy
Description
Short Assessment of Health Literacy-English is an 18-item scale assessing adult's ability to read and understand common medical terms.
Time Frame
Pre and Post intervention (3 months)
Title
Health Related Quality of life
Description
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.
Time Frame
Pre and Post intervention (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician Proficiency in English Exclusion Criteria: Dementia
Facility Information:
Facility Name
University of Califonia, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anny Reyes, PhD
Phone
646-648-7154
Email
anr086@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Anny Reyes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Healthy Aging in People With Epilepsy Program

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