On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT04871698

Collaborator

Texas A&M University (Other), Baylor Research Institute (Other), Georgia Institute of Technology (Other)

140

Enrollment

Location

18.5

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Dementia Alzheimers

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

140 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System

Actual Study Start Date :

Sep 14, 2020

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birkeland Current	Waco	Texas	United States	76704

Sponsors and Collaborators

National Institute on Aging (NIA)
Texas A&M University
Baylor Research Institute
Georgia Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Fitch, Principal Investigator, National Institute on Aging (NIA)

ClinicalTrials.gov Identifier:

NCT04871698

Other Study ID Numbers:

R44AG065118

First Posted:

May 4, 2021

Last Update Posted:

May 4, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Alzheimer Disease

Study Results

No Results Posted as of May 4, 2021