Recruiting

Continuous Monitoring

Sponsor:

National Institute on Aging (NIA)

Code:

NCT04871698

Conditions

Dementia

Dementia Alzheimers

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Dementia

Dementia Alzheimers

Study ID

NCT04871698

Start date

Sep 14, 2020

Status verified date

Apr, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melissa SoRelle

254-742-6030melissa.sorelle@birkelandcurrent.com

Sarah Fitch, MA

254-742-6034sarah.fitch@birkelandcurrent.com

Locations

Birkeland Current

Recruiting

Waco, Texas, United States, 76704

Contacts

Melissa SoRelle

254-742-6030melissa.sorelle@birkelandcurrent.com

Sarah Fitch

254-742-6034sarah.fitch@birkelandcurrent.com

More Information

Sponsor

National Institute on Aging (NIA)

Last update posted

May 4, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Aging (NIA) on 2021-05-04.