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Mobile App to Monitor Dementia-Related Agitation

Recruiting

People with dementia can become increasingly agitated as the disease gets worse. Agitation can appear in different ways, such as pacing, sleeplessness, or aggression. This study will test the feasibility of using a monitoring application, or app, on a smartphone or wearable device, to track activities and some health measures, such as heart rate, of individuals with dementia-related agitation.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years N/A All No
June 2020
June 2021
30

  • Meet DSM-V diagnosis criteria for dementia
  • Recent history of agitation in the past six months, severe enough that it interferes with activities of daily living or social interaction
  • Living in a group home, nursing home, or assisted living facility
  • Able to read, understand, and provide written informed consent or have a legally acceptable representative
  • Willing and able to carry a smartphone and wear an activity tracker on their wrist or hand, alone or with the help of a caregiver
  • Able to operate a smartphone and wrist or hand-worn activity tracker, either alone or with the help of a caregiver
  • Good general health prior to study participation as determined by a detailed medical history, and in the opinion of the study contact
  • Able to walk and move about freely, without an assistive device, such as a cane

  • Subjects with serious or unstable medical illnesses. These include current liver, kidney, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic, or blood-related disease
  • Anyone considered by the study contact, for any reason, to be an unsuitable candidate

Participants will be required to carry a smartphone and wear an activity tracker on their wrist or hand. On the smartphone or device, the HealthMode Agitation application (app) will collect information, in real-time, about the participants' motion and location, sounds and physical health measurements, information about comfort, usability, and participants' responses to alerts and messages. The study will help researchers test and improve the HealthMode Agitation app to help monitor and support people who have dementia-related agitation.

Name City State Zip Status Primary Contact
Tucson Neuroscience Research, LLC
Tucson Arizona 85710 Recruiting Diana Benenati, MD
520-881-8400
hm060401@healthmode.com

HealthMode Inc.

NCT04413851

A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia