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Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:

NCT03360019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-05-17

Study results available
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Summary

In this Phase II SBIR project we will enhance a wireless WiFi-based insole that was designed and successfully tested during a Phase I trial with elderly persons with dementia and their caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and quality of life in Phase II. Evaluation will use semi-structured interviews and participant observation data collected from professional and family caregivers of patients with moderate or mild dementia.

Conditions

  • Dementia, Vascular
  • Alzheimer Dementia
  • Lewy Body Dementia With Behavioral Disturbance

Interventions

DEVICE

Activlink insole

Dementia patients will wear the provided insole inserted into their own shoes. The insole will have a small electronic sensor that measures acceleration, foot force, and/or orientation.

OTHER

Activlink Phone Application

Smartphone tool used for monitoring location

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Aster Labs, Inc

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Glenn Smith, PhD, ABPP-cn · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360019 on ClinicalTrials.gov