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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Activlink insole
* Other: Activlink Phone Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Residents in memory care or skilled nursing Facility<br> | Device: Activlink insole<br>* 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.<br>* Other names: Location Monitoring Technology;|
| Active Comparator: Resident in independent living setting<br> | Device: Activlink insole<br>* 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.<br>* Other names: Location Monitoring Technology;|
| Other: Care Partners<br> | Other: Activlink Phone Application<br>* Smartphone tool used for monitoring location<br>* Other names: Location Monitoring Technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |