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

Not Applicable

Completed

• Conditions: Lewy Body Dementia With Behavioral Disturbance; Dementia, Vascular; Alzheimer Dementia
• Interventions: Device: Activlink insole; Other: Activlink Phone Application

• Registration Number: NCT03360019
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Study Start: 2021-01-27
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Results First Submitted: 2023-02-08
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Residents in memory care or skilled nursing Facility	Activlink insole	-
Care Partners	Activlink Phone Application	-
Resident in independent living setting	Activlink insole	-

Primary Outcome Measures

Name	Time	Method
Caregiver Activity Survey	week 2	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.

Secondary Outcome Measures

Name	Time	Method
Zarit Caregiver Burden Scale	Up to 6 months	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.
AD Quality of Life Scale	up to 6 months	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.

Trial Locations

Locations (2)

Oak Hammock Senior Living Center; 🇺🇸 Gainesville, Florida, United States

Unversity of Florida; 🇺🇸 Gainesville, Florida, United States