On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

April 29, 2021 updated by: John Fitch, National Institute on Aging (NIA)

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults 65 and older with mild to moderate dementia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

Texas A&M University
Baylor Research Institute
Georgia Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44AG065118 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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