Feasibility of Passive Data Collection in Dementia Subjects With Agitation

A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Frontotemporal Dementia; Vascular Dementia; Lewy Body Dementia; Mixed Dementia

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research, LLC
  • New York
    • New York, New York, United States, 10001
      • Virtual Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability.	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.	Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment: Cleaned single channel data compared to assessments; Cleaned multichannel data compared to assessments; Analyzed multichannel data compared to assessments; Subject/Caregiver assessment data compared to agitation scale ratings; Agitation scale ratings compared to cleaned single and multichannel data and analyzed multichannel data.; Merged subject/caregiver assessment and multichannel data compared to agitation scale ratings	28 days

Collaborators and Investigators

• Sponsor: HealthMode Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): December 6, 2021
• Study Completion (ACTUAL): December 6, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Intracranial Arterial Diseases; Speech Disorders; Frontotemporal Lobar Degeneration; Intracranial Arteriosclerosis; Leukoencephalopathies; Aphasia; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular
• Other Study ID Numbers: HM060401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No