Development of Memesto, a Wearable Repetitive Message and Music Therapy Device That Senses and Reduces Agitation in Persons With AD/ADRD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Average score on the Neuropsychiatric Inventory (NPI) agitation domain
研究概览
简要总结
This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care facility. It is hypothesized that Memesto use will result in a reduction in agitation.
详细描述
After informed consent is obtained and preliminary eligibility established, participants will be trained and issued the Memesto device for use over a 2-week screening/training phase. Participants successfully completing this phase will proceed into a 10-week open label treatment phase (via telephone and/or in-person data collection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Given that people living with ADRD can be of any adult age, people meeting criteria for ADRD diagnosis will be regardless of age. Younger-onset people living with ADRD, which may be smaller, will be considered for participation along with adults older than age 65 that make up the largest portion of persons living with ADRD. The family and professional caregivers can be any age greater than eighteen. We anticipate that 5% of the People living with ADRD will be less than age 65 with 70% being greater than age 75 and 25% being between ages 65 and
- •For family caregivers, we envision most will be spouses with the same age distributions as the parents with a skew to a slightly younger age group for caregivers who are children of the person living with ADRD and/or the spouses of children. For professional caregivers, we anticipate they will be between the residential care workforce ages of 20 and 65 with a skew toward persons over age
排除标准
- •Eligible participants will be adults with a dementia diagnosis who have clinically significant agitation, defined as a state of poorly organized and purposeless psychomotor activity characterized by at least one of the following: aggressive verbal (screaming, cursing), aggressive physical (destroying objects, grabbing, fighting), or non-aggressive physical (restlessness, pacing) behaviors. The behavioral symptoms must be severe enough to warrant pharmacological treatment. A family caregiver must be willing to participate along with a professional caregiver from the resident living facility.
结局指标
主要结局
Average score on the Neuropsychiatric Inventory (NPI) agitation domain
时间窗: 10 weeks
The scores on the NPI agitation domain at baseline will be the comparator. A score of zero indicates no agitation is observed. If agitation is mentioned, caregivers will rate the agitation symptom frequency from 1 to 4 (less than once a week, about one time a week, several times a week, or more than once per day). Severity for each symptom is rated from 1 to 3 (mild, moderate, or marked). The NPI's composite (frequency x severity) score ranges from 1 to 12 for each positively endorsed domain.13 The average of the family and professional caregiver rating will be utilized
次要结局
未报告次要终点
研究者
Jeffery T. Banker
President
Edgewater Safety Systems, Inc.