Status:
COMPLETED
Feasibility of Passive Data Collection in Dementia Subjects With Agitation
Lead Sponsor:
HealthMode Inc.
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, p...
Eligibility Criteria
Inclusion
- Male and female subjects 18 years and older.
- Subjects who have met DSM-5 criteria for Dementia (all cause)
- Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.
- Subjects resident in a group home, nursing home, or assisted living are eligible to participate.
- Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)
- Subjects who are 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.
- Subjects who, either alone or with a caregiver, are able to operate a smartphone and wrist or hand-worn activity tracker, alone or with the help of a caregiver.
- Subjects who are in good general health prior to study participation as determined by a detailed medical history, and in the opinion of the Principal Investigator.
- Subjects, who are able to ambulate without an assistive device, or with a single point cane.
Exclusion
- Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.
- Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04413851
Start Date
June 1 2020
End Date
December 6 2021
Last Update
December 17 2021
Active Locations (2)
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1
Tucson Neuroscience Research, LLC
Tucson, Arizona, United States, 85710
2
Virtual Research Site
New York, New York, United States, 10001