On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System
1 other identifier
observational
140
1 country
1
Brief Summary
The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 4, 2021
April 1, 2021
1.5 years
April 29, 2021
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment
The ADCS-ADL/23 assessment will be utilized to measure changes in activities of daily living in the sample population while BC's system is also in place independently measuring the changes in activities of daily living.
18 months
Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes
AI techniques will search sensor data for subfactor and novel groupings for statistically significant improvements from what is measured by the ADCS/ADL-23 assessment of decline.
18 months
Secondary Outcomes (1)
Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research
18 months
Eligibility Criteria
Adults 65 and older with mild to moderate dementia.
You may qualify if:
- Fluent in English to understand and sign the consent or assent documents.
- Adult over 65 years of age with no children under 18 years old living in residence.
- Adult anticipates they will be living primarily at designated residence over next 18 months.
- Must receive caregiver interaction at least 6 hours/week.
- Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study.
- Must be willing to have home or facility equipped with sensors to obtain activity and location data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)lead
- Texas A&M Universitycollaborator
- Baylor Research Institutecollaborator
- Georgia Institute of Technologycollaborator
Study Sites (1)
Birkeland Current
Waco, Texas, 76704, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 4, 2021
Study Start
September 14, 2020
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
May 4, 2021
Record last verified: 2021-04