Epilepsy
Conditions
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: * 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).
Interventions
BEHAVIORALHealthy 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.
OTHERPatient Survey
Patients 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.
OTHERProvider Survey
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
Sponsors
Anny Reyes
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Part 1a - Patient Survey: * Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician * Age 55 years or older * Proficiency in English (self-assessed) * Part 1b - Provider Survey: * Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy (including Epilepsy Foundation organizational leaders) * Part 3: * Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician * Age 55 years or older (up to 90) * Proficiency in English (self-assessed)
Exclusion criteria
* Part 1a: * Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded) * Age 90 years or older * Part 3: * Evidence of Dementia (based on phone cognitive screener; those with suspected mild cognitive impairment will not be excluded) * Age 90 years or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dementia Knowledge | Baseline (Week 0) and post-intervention (Month 3) | 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). |
| Acceptability of Study Program | Post-intervention (Month 3) | Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program) |
| Program Satisfaction | Post-intervention (Month 3) | As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction) |
| Epilepsy Self-Management | Baseline (Week 0) and post-intervention (Month 3) | 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). |
| Attitudes about Aging | Baseline (Week 0) and post-intervention (Month 3) | As measured by the Attitudes about Aging questionnaire (3 subscales with Min-Max 8-40; for two subscales, higher score mean more positive attitude; and for the third subscale, higher score means more negative attitude) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health literacy | Baseline (Week 0) and post-intervention (Month 3) | 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) |
| Participant's Quality of life | Baseline (Week 0) and post-intervention (Month 3) | 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"). |
| Participant's confidence in managing different aspects of health | Baseline (Week 0) and post-intervention (Month 3) | 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) |
| Participant's Mood | Baseline (Week 0) and post-intervention (Month 3) | 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) |
| Cognitive Function | Baseline (Week 0) and post-intervention (Month 3) | As measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (raw scores are converted to scaled scores to adjust for age, higher scores indicate better performance), the Trail Making Test (measured by total time of completion with higher scores indicating poorer performance), the Test of Practical Judgment (raw scores converted to z-scores based on normative sample, lower z-scores indicating loss of everyday judgment abilities), the Everyday Cognition (scored by on four-point scale, higher total score indicates greater subjective decline in cognitive function), and the Functional Assessment Questionnaire (Min-Max 0-30, higher scores indicate greater impairment in activities of daily living) |
| Sleep quality | Baseline (Week 0) and post-intervention (Month 3) | Measured with the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures the quality and patterns of sleep in older adults. A global score is generated ranging from 0 to 21, with total score higher than 5 indicating "poor" sleeper. |
| Health-promoting behaviors | Baseline (Week 0) and post-intervention (Month 3) | Health promoting behaviors will be measured with the Health-Promoting Lifestyle Profile II (HPLP-II). The HPLP-II is a 52-item behavior rating scale employs a 4-point response format to measure the frequency of self-reported health-promoting behaviors in the domains of health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management. A total score is generating by averaging across all 52 items with higher scores indicating higher number of health-promoting behaviors. Six subscales are also generated by averaging across the items for each subscale. |
| Cognitive screening | Baseline | The Telephone Montreal Cognitive Assessment (T-MoCA) will be used as screening tool of cognition; the T-MoCA is a modified version of the MoCA-30 that can be administered by phone and measures global cognitive functioning. Raw scores range from 0 to 22 with higher scores indicating better performance. |
| Alcohol and smoking history | Baseline (Week 0) and post-intervention (Month 3) | Information on alcohol use including frequency and types of alcohol consumed and smoking status, amount of smoking, and age at smoking cessation will also be collected. |
Countries
United States
Contacts
CONTACTAnny Reyes, PhD
PRINCIPAL_INVESTIGATORAnny Reyes, PhD
The Cleveland Clinic
Outcome results
None listed