Feasibility of Passive Data Collection in Dementia Subjects With Agitation

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    HealthMode Inc.
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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 18years - 100years
Clinical Study IdentifierNCT04413851
SponsorHealthMode Inc.
Last Modified on19 February 2024

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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