Feasibility of Passive Data Collection in Dementia Subjects With Agitation
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|ClinicalTrials.gov Identifier: NCT04413851|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : July 29, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction.
- 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.
- 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.
- 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:
- 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
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
|United States, Arizona|
|Tucson Neuroscience Research, LLC||Recruiting|
|Tucson, Arizona, United States, 85710|
|Contact: Diana Benenati, MD 520-881-8400 email@example.com|
|Principal Investigator: Diana Benenati, MD|