Feasibility of Passive Data Collection in Dementia Subjects With Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia Alzheimer Disease Vascular Dementia Frontotemporal Dementia Lewy Body Dementia Mixed Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dementia

Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson Neuroscience Research, LLC

Tucson, Arizona, United States

Site Status

Virtual Research Site

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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HM060401

Identifier Type: -

Identifier Source: org_study_id