Healthy Aging in People With Epilepsy Program (HAP-E)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06052605 |
Recruitment Status :
Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy | Behavioral: Healthy Aging in People with Epilepsy Program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care |
Estimated Study Start Date : | August 1, 2024 |
Estimated Primary Completion Date : | July 1, 2027 |
Estimated Study Completion Date : | June 1, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: HAP-E Epilepsy Participants |
Behavioral: Healthy Aging in People with Epilepsy Program
This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors. |
- 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.
- 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.
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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
- Proficiency in English
Exclusion Criteria:
- Dementia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052605
United States, California | |
University of Califonia, San Diego | |
San Diego, California, United States, 92093 | |
Contact: Anny Reyes, PhD 646-648-7154 anr086@health.ucsd.edu | |
Principal Investigator: Anny Reyes, PhD |
Responsible Party: | Anny Reyes, Postdoctoral Fellow, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT06052605 |
Other Study ID Numbers: |
HAPE2023 |
First Posted: | September 25, 2023 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |