Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Anny Reyes
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Health literacy
研究概览
简要总结
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:
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
- •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)
排除标准
- •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
研究组 & 干预措施
Part 1a: Patient 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.
干预措施: Patient Survey (Other)
Part 1b: Provider Survey
Providers will receive an online survey to identify barriers in accessing geriatric care, target educational topics, and concerns about aging.
干预措施: Provider Survey (Other)
Part 3: Intervention
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.
干预措施: Healthy Aging in People with Epilepsy Program (Behavioral)
Part 3: Control
Participants randomized to this group will receive standard care during their participation
结局指标
主要结局
Health literacy
时间窗: 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
时间窗: 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.
Dementia Knowledge
时间窗: 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.
次要结局
未报告次要终点
研究者
Anny Reyes
Associate Staff, Principal Investigator
The Cleveland Clinic