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Feasibility of Passive Data Collection in Dementia Subjects With Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413851
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
HealthMode Inc.

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.


Condition or disease
Dementia Alzheimer Disease Vascular Dementia Frontotemporal Dementia Lewy Body Dementia Mixed Dementia

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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.



Primary Outcome Measures :
  1. Feasibility of passive and continuous data collection [ Time Frame: 28 days ]
    Total time and percentage of continuous data collection for each stream of data aiming for >50% coverage.


Secondary Outcome Measures :
  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. [ Time Frame: 28 days ]
    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.


Other Outcome Measures:
  1. Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data. [ Time Frame: 28 days ]

    Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment:

    1. Cleaned single channel data compared to assessments
    2. Cleaned multichannel data compared to assessments
    3. Analyzed multichannel data compared to assessments
    4. Subject/Caregiver assessment data compared to agitation scale ratings
    5. Agitation scale ratings compared to cleaned single and multichannel data and analyzed multichannel data.
    6. Merged subject/caregiver assessment and multichannel data compared to agitation scale ratings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413851


Locations
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United States, Arizona
Tucson Neuroscience Research, LLC Recruiting
Tucson, Arizona, United States, 85710
Contact: Diana Benenati, MD    520-881-8400    hm060401@healthmode.com   
Principal Investigator: Diana Benenati, MD         
Sponsors and Collaborators
HealthMode Inc.
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Responsible Party: HealthMode Inc.
ClinicalTrials.gov Identifier: NCT04413851    
Other Study ID Numbers: HM060401
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Dementia, Vascular
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Neurobehavioral Manifestations
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases