Memesto Wearable Device for Persons With Dementia
- Conditions
- Alzheimer Disease
- Interventions
- Device: Memesto
- Registration Number
- NCT05153161
- Lead Sponsor
- Edgewater Safety Systems, Inc.
- Brief Summary
An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that diminishes their quality of life. The goal of this Small Business Innovation Research (SBIR) project is to develop a wearable therapy device that automatically senses rising agitation, and alerts caregivers while deploying calming voice and music therapy to help them avoid crisis level behavior. This device will improve health outcomes for AD/ADRD sufferers and reduce the substantial stress suffered by their caregivers.
- Detailed Description
Edgewater Safety Systems developed a smart wearable media player (Memesto) that family and other caregivers could use with a web app to record, schedule and deliver voice and music to an ADRD patient through this device. Caregivers were able to record greetings, reminders to take medication, drink water or eat lunch, and these messages could be played for the patient via the device at set dates and times. In a follow-up survey with caregivers who used the Memesto with patients at care facilities, 11 of 11 rated it 4.5 out of 5 for "usefulness in mitigating agitation." Edgewater proposes to develop a more innovative wearable device that senses rising agitation in the patient and automatically plays therapeutic messages and music shown to have had the greatest success reducing or eliminating agitation in the wearer's previous episodes. With this next generation Memesto, Edgewater aims to improve quality of life for a diverse population of ADRD persons; diminish the use of potentially harmful drugs as an intervention; and help reduce stress and burnout in caregivers. The new Memesto will have four key elements of innovation: 1) repetitive, programmable voice and music therapy in a wearable device, a first for AD/ADRD care; 2) web-based app that enables family and friends to deliver personal messages and music anytime; 3) agitation-sensing system that reads biometric data from non-invasive body-worn sensors to automatically deploy media therapy; and 4) sensor data taken at start and end of the played media to determine effectiveness of that media in reducing agitation and continually prioritize the most effective media.In the Phase I study, Edgewater will partner with Rush Alzheimer's Disease Center to: 1) carry out a 10-week clinical trial on 20 ADRD persons to gather quantitative evidence of the original audio player's effectiveness at reducing agitation; and 2) demonstrate feasibility of ADRD agitation detection and automated intervention. Phase II will focus on complete implementation of a fully automated, miniaturized, wearable Memesto device and a broad field trial testing efficacy of the new agitation sensing and automated intervention system.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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.13 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 residential living facility.
- Persons could screen fail if the device cannot be utilized by the person living with AD/ADRD, family caregiver, or professional caregiver.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Persons with ADRD living in a residential care facility Memesto Each consented participant will receive the current Memesto device and will be provided formal and informal training instructions. After consent and screening, a two-week training period with a Memesto device will be followed by ten weeks of data collection. An experienced research assistant will administer the baseline NPI in order to collect the agitation ratings by the family caregiver, and the professional caregiver will be collected by a trained research assistant and captured in an electronic case report form designed using REDCap.14,15 Then, participants will undergo evaluation of the NPI agitation domain at 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 10 weeks. Adverse events related to the device will be collected from the family and professional caregivers. Human centered system designers will work with the operations team to enhance participant engagement and maintain high quality data collection.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score 10 weeks The NPI agitation domain score is a composite score (symptom frequency x severity) ranging from 1 to 12; a higher score represents greater distress.
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 10 in average Clinical Global Impression - Severity (CGI-S) score 10 weeks The CGI-S is rated on a 7-point Likert scale with responses ranging from 1 to 7; a higher score represents greater severity of illness.
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States