Feasibility of Passive Data Collection in Dementia Subjects With Agitation

NCT04413851 | Completed

• 1 other identifier: HM060401
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of passive and continuous data collection

  Total time and percentage of continuous data collection for each stream of data aiming for \>50% coverage.

  28 days

Secondary Outcomes (1)

• 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.

  28 days

Other Outcomes (1)

• Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.

  28 days

Study Arms (1)

Dementia

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthMode Inc.: lead

Study Sites (2)

Tucson Neuroscience Research, LLC

Tucson, Arizona, 85710, United States

Location

Virtual Research Site

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Frontotemporal Dementia; Lewy Body Disease; Mixed Dementias

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (2)