Feasibility of Passive Data Collection in Dementia Subjects With Agitation

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413851
• Other study ID #: HM060401
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 6, 2021

Study information

• Verified date: December 2021
• Source: HealthMode Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Dementia
• Lewy Body Disease
• Mixed Dementia
• Pick Disease of the Brain
• Vascular Dementia

Locations

Country	Name	City	State
United States	Virtual Research Site	New York	New York
United States	Tucson Neuroscience Research, LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HealthMode Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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