NCT03360019

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-27
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2017-12-02
• Last updated: 2023-05-17
• Results posted: 2023-05-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study