Feasibility of Passive Data Collection in Dementia Subjects With Agitation

STATUS

Recruiting
participants needed

30
sponsor

HealthMode Inc.

Updated on 19 February 2024

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dementia

agitation

functional activities

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, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).

The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.

Details

Condition	Lewy Body Disease, Frontotemporal dementia, Pick's Disease, Vascular dementia, Dementia, Dementia, Alzheimer's Disease, Alzheimer's Disease, lewy body dementia, Mixed Dementia
Age	18-100 years
Clinical Study Identifier	NCT04413851
Sponsor	HealthMode Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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

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Step 4 Get your study results

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Feasibility of Passive Data Collection in Dementia Subjects With Agitation