On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

• Conditions: Dementia; Dementia Alzheimers

• Registration Number: NCT04871698
• Lead Sponsor: National Institute on Aging (NIA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Status Verified: 2021-04
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment	18 months	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.
Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research	18 months	Database structures and meta-data will be established for anonymous data sets.

Trial Locations

Locations (1)

Birkeland Current; 🇺🇸 Waco, Texas, United States