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

University of Florida

Status: Completed

Conditions: Alzheimer Dementia; Lewy Body Dementia With Behavioral Disturbance; Dementia, Vascular

Treatments: Other: Activlink Phone Application; Device: Activlink insole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03360019

5R44AG046944-03 (U.S. NIH Grant/Contract)

OCR17448 (Other Identifier)

IRB201702352 -N -A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Residents in memory care or skilled nursing Facility

Active Comparator group

Treatment:

Device: Activlink insole

Resident in independent living setting

Active Comparator group

Treatment:

Device: Activlink insole

Care Partners

Other group

Treatment:

Other: Activlink Phone Application