Healthy Aging in People With Epilepsy Program
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-90
SponsorAnny Reyes
About 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:
* Be randomized to an intervention group or a control group. * Complete a 12-week group educational program (intervention group). * Complete pre- and post-program evaluation (intervention and control groups).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
Age 55 years or older
Proficiency in English (self-assessed)
Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy (including Epilepsy Foundation organizational leaders)
Disqualifiers
Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
Age 90 years or older
Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded)
Age 90 years or older
Trial design
Design model
Sequential
Treatments tested in this trial
Healthy Aging in People with Epilepsy Program
BehavioralThis a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.
Patient Survey
Other interventionPatients with receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. Additionally, they will be surveyed on unmet needs in their care, availability of healthcare information and resources related to aging and dementia, and elements of the program most important to them.
Provider Survey
Other interventionProviders will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Treatment groups
380 Participants
are divided into 4 treatment groupsGroup A: Part 1a: Patient SurveyOther 1 intervention
Group B: Part 1b: Provider SurveyOther 1 intervention
Group C: Part 3: InterventionExperimental treatment 1 intervention
Group D: Part 3: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 (higher score indicates greater dementia knowledge).
Time frame
Baseline (Week 0) and post-intervention (Month 3)2
Acceptability of Study Program
Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program)
Time frame
Post-intervention (Month 3)3
Program Satisfaction
As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
Time frame
Post-intervention (Month 3)4
Epilepsy Self-Management
Use of epilepsy self-management practices will be assessed with the Epilepsy Self-Management Scale (Min-Max 38-190, higher score means more frequent use of self-management strategies).
Time frame
Baseline (Week 0) and post-intervention (Month 3)Secondary outcomes
1
Health literacy
Assessment of participants' health literacy will be done by the Short Assessment of Health Literacy-English (Min-Max 0-18, lower number indicates lower health literacy)
Time frame
Baseline (Week 0) and post-intervention (Month 3)2
Participant's Quality of life
As assessed by Quality of life in Epilepsy-31 (raw scores are converted to T-scores and higher T-scores indicate better quality of life) and the Quality of Life in Neurological Disorders (Likert scale format ranging from "Never" to "Always").
Time frame
Baseline (Week 0) and post-intervention (Month 3)3
Participant's confidence in managing different aspects of health
As measured by the Chronic Disease Self-Efficacy Scale (contains 10 subscales where the score for each scale is the mean of the items, higher numbers indicate higher self-efficacy)
Time frame
Baseline (Week 0) and post-intervention (Month 3)4
Participant's Mood
As measured by Geriatric Anxiety Inventory (Min-Max 0-20, higher scores indicate greater number of reported anxiety symptoms) and Geriatric Depression Scale (Min-Max 0-15, higher score indicates more depression symptoms)
Time frame
Baseline (Week 0) and post-intervention (Month 3)Other outcomes
1
Participant clinical and demographic characteristics
Participant age, gender, race, ethnicity, marital status, education level, primary language, and working status/profession will be collected of all participants. Epilepsy clinical history including age of onset, medications, seizure frequency, history and type of surgery, injury related to and seizures. Other medical and psychiatric history including hypertension, diabetes, hyperlipidemia, mood disorders (depression, anxiety), and family history of dementia.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anny Reyes
Lead sponsor
The Cleveland Clinic
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov