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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
Sponsor:
Information provided by (Responsible Party):
Anny Reyes, University of California, San Diego

Study Description
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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:

  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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Healthy Aging in People with Epilepsy Program Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Dementia
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
University of California, San Diego
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases