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On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

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ClinicalTrials.gov Identifier: NCT04871698
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
Texas A&M University
Baylor Research Institute
Georgia Institute of Technology
Information provided by (Responsible Party):
John Fitch, 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.

Condition or disease
Dementia Dementia Alzheimers

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 65 and older with mild to moderate dementia.
Criteria

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:

-


Information from the National Library of Medicine

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): NCT04871698


Contacts
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Contact: Melissa SoRelle 254-742-6030 melissa.sorelle@birkelandcurrent.com
Contact: Sarah Fitch, MA 254-742-6034 sarah.fitch@birkelandcurrent.com

Locations
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United States, Texas
Birkeland Current Recruiting
Waco, Texas, United States, 76704
Contact: Melissa SoRelle    254-742-6030    melissa.sorelle@birkelandcurrent.com   
Contact: Sarah Fitch    254-742-6034    sarah.fitch@birkelandcurrent.com   
Sponsors and Collaborators
National Institute on Aging (NIA)
Texas A&M University
Baylor Research Institute
Georgia Institute of Technology
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Responsible Party: John Fitch, Principal Investigator, National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT04871698    
Other Study ID Numbers: R44AG065118 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases