Clinical trial NCT04413851: Feasibility of Passive Data Collection in Dementia Subjects With Agitation
Official title: A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Alzheimer Disease
Vascular Dementia
Frontotemporal Dementia
Lewy Body Dementia
Mixed Dementia
Lead sponsor: HealthMode Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible individuals who have a diagnosis of dementia and a recent history of agitation will sign an informed consent, with a legally authorized representative (LAR) when necessary, to enroll in the study.

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of passive and continuous data collection
timeFrame: 28 days
Secondary outcomes:
measure: Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.
timeFrame: 28 days
Other outcomes:
measure: Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.
timeFrame: 28 days
Locations:
city: Tucson
country: United States
facility: Tucson Neuroscience Research, LLC
state: Arizona
city: New York
country: United States
facility: Virtual Research Site
state: New York
Study officials:
References: