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

Dementia, Vascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360019
• Other study ID #: IRB201702352 -N -A
• Secondary ID: OCR174485R44AG04
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia
• Dementia, Vascular
• Lewy Body Dementia With Behavioral Disturbance
• Lewy Body Disease
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Oak Hammock Senior Living Center	Gainesville	Florida
United States	Unversity of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Aster Labs, Inc, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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