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

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

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.

Study Overview

• Status: Completed
• Conditions: Lewy Body Dementia With Behavioral Disturbance; Dementia, Vascular; Alzheimer Dementia
• Intervention / Treatment: Device: Activlink insole; Other: Activlink Phone Application

Detailed Description

The efficacy of the Activlink system offering localization information to improve caregiver will be evaluated in two studies. Study 2a will use the insole system with dementia patients residing in skilled or memory care. Data regarding caregiving activity will be collected from their paid professional care providers. Study 2b will use participant localization data collected on 80 independently dwelling mild dementia patients. In this case data will be collected from their unpaid family caregivers. Both studies will result in evaluating the efficacy of the WiFi-based insole to provide caregivers with augmented patient awareness, helping to improve their immediate quality of life by reducing their direct burden of continuous oversight of their person in care.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Unversity of Florida
    • Gainesville, Florida, United States, 32608
      • Oak Hammock Senior Living Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Persons With Dementia Resides in memory care or skilled nursing

• Moderate dementia (MMSE of 10-18)
• Ambulatory (without or with cane, walker or wheelchair assist)
• A legal proxy that can provide consent

Persons With Dementia Resides in independent living setting in community.

• Mild dementia (MMSE of 19-25)
• Ambulatory (without or with cane, walker or wheelchair assist).
• Has a legal proxy that can provide consent.

Care Partners

• Speaks English
• Be 21 years of age or over
• Has at least three times per week direct contact with person with dementia (PWD)
• Consents to participate in the study

Exclusion Criteria:

• Is not fluent in written or spoken English
• Indicate an unwillingness to use the Activlink
• History of Major Mental Illness for patient or caregiver

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Residents in memory care or skilled nursing Facility	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 Names: Location Monitoring Technology
Active Comparator: Resident in independent living setting	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 Names: Location Monitoring Technology
Other: Care Partners	Other: Activlink Phone Application; Smartphone tool used for monitoring location; Other Names: Location Monitoring Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Activity Survey	Validated scale requires caregivers to report on amount of time spent caregiving for a particular patient. It has high test-retest reliability. Caregivers will be asked to complete this instrument once every two weeks. The scale describes the total number of minutes spent daily on six different caregiving activities. Therefore the minimum value for each item is 0 and the maximum is 1,440 for each item. Higher scores on each item mean more time spent caregiving.	week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Caregiver Burden Scale	This is validated instrument designed to reflect what people sometimes feel when taking care of another person. Caregivers will be asked to complete this instrument once every two weeks. Total score was calculated. Scores ranged from 0-48 with a higher score indicating greater caregiver burden.	Up to 6 months
AD Quality of Life Scale	Assesses Caregiver quality of life with 13 questions rating from poor to excellent. Caregivers circle their responses. Caregivers will be asked to complete this instrument once every two weeks. Total score was calculated. Scores ranged from 13-52, with a higher score indicating better quality of life in caregivers.	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Accuracy	Percentage of physical checks where device displayed correct location of patient/resident. Only partners reported on the accuracy. No data were required from participants. Therefore, they were entered as 0s in the chart.	First month of overall study period

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA); Aster Labs, Inc
• Investigators: Principal Investigator: Glenn Smith, PhD, ABPP-cn, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Problem Behavior; Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular
• Other Study ID Numbers: IRB201702352 -N -A; OCR17448 (Other Identifier: OnCore); 5R44AG046944-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes