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

NCT03360019 | Completed Results FDA Device

• 3 other identifiers: IRB201702352 -N -AOCR174485R44AG046944-03
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Zarit Caregiver Burden Scale

  Up to 6 months

• AD Quality of Life Scale

  up to 6 months

Other Outcomes (1)

• Device Accuracy

  First month of overall study period

Study Arms (3)

Residents in memory care or skilled nursing Facility

ACTIVE COMPARATOR

Device: Activlink insole

Resident in independent living setting

ACTIVE COMPARATOR

Device: Activlink insole

Care Partners

OTHER

Other: Activlink Phone Application

Interventions

Activlink insole DEVICE

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.

Also known as: Location Monitoring Technology

Resident in independent living setting; Residents in memory care or skilled nursing Facility

Activlink Phone Application OTHER

Smartphone tool used for monitoring location

Also known as: Location Monitoring Technology

Care Partners

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• Aster Labs, Inc: collaborator

Study Sites (2)

Oak Hammock Senior Living Center

Gainesville, Florida, 32608, United States

Location

Unversity of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Dementia, Vascular; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Limitations and Caveats

Participants from study 2A discontinued before the end of the intervention period, and caregiving nurse practitioners failed to respond to the surveys biweekly. Only 4 surveys were collected by the end of study 2A. Largely because of the Corona Virus 19 pandemic all contacted participants from study 2B declined or withdrew consent of baseline data collection and treatment implementation. Therefore, no data were collected for this phase of the study.

Results Point of Contact

• Title: Glenn Smith
• Organization: University of Florida

glennsmith@ufl.edu

352-273-6556

Study Officials

• Glenn Smith, PhD, ABPP-cn

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Counterbalanced within-subject design. Specifically, each target patient will randomly be assigned to either have the technology or not have the technology applied for a period of three months, followed by three months of the opposite condition. Caregivers will provide caregiver ratings twice monthly during these two epochs.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: January 27, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-05

Locations

US (2)