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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NS138682-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: Patient Survey | Other | 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. |
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| Part 1b: Provider Survey | Other | Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. |
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| Part 3: Intervention | Experimental | Participants randomized to this group will receive a 12-week group educational program (either virtual or in-person based on patient preference) providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors. |
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| Part 3: Control | No Intervention | Participants randomized to this group will receive standard care during their participation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Aging in People with Epilepsy Program | Behavioral | This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Week 0) and post-intervention (Month 3) |
| Acceptability of Study Program | Defined by participation rate of 80% or greater in intervention (higher number indicates greater acceptability of the program) | Post-intervention (Month 3) |
| Program Satisfaction | As assessed by Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction) | Post-intervention (Month 3) |
| 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). | Baseline (Week 0) and post-intervention (Month 3) |
| Attitudes about Aging | 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) | Baseline (Week 0) and post-intervention (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (Week 0) and post-intervention (Month 3) |
| Participant's Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anny Reyes, PhD | Contact | 216-390-4266 | REYESA14@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Anny Reyes, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
De-identified individual participant data to be shared will include clinical and demographic information, quantitative survey responses, self-report and cognitive assessment data, and summaries of focus group discussions with stakeholder recommendations, along with associated documentation such as codebooks and analytic materials to support interpretation and reuse.
Beginning within the first year after study completion (August 2030) with no end date.
IPD and supporting information will be accessible to the general public, who will be able to obtain de-identified participant data and relevant documentation through open, unrestricted access on a public data-sharing platform.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Patient Survey | Other | 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. |
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| Provider Survey | Other | Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging. |
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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"). |
| Baseline (Week 0) and post-intervention (Month 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) | Baseline (Week 0) and post-intervention (Month 3) |
| 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) | Baseline (Week 0) and post-intervention (Month 3) |
| Cognitive Function | 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) | Baseline (Week 0) and post-intervention (Month 3) |
| Sleep quality | 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. | Baseline (Week 0) and post-intervention (Month 3) |
| Health-promoting behaviors | 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. | Baseline (Week 0) and post-intervention (Month 3) |
| Cognitive screening | 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. | Baseline |
| Alcohol and smoking history | 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. | Baseline (Week 0) and post-intervention (Month 3) |
| Baseline |