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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2022-05-31

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.

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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.

Conditions

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Dementia, Vascular Alzheimer Dementia Lewy Body Dementia With Behavioral Disturbance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Residents in memory care or skilled nursing Facility

Group Type ACTIVE_COMPARATOR

Activlink insole

Intervention Type DEVICE

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.

Resident in independent living setting

Group Type ACTIVE_COMPARATOR

Activlink insole

Intervention Type DEVICE

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.

Care Partners

Group Type OTHER

Activlink Phone Application

Intervention Type OTHER

Smartphone tool used for monitoring location

Interventions

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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.

Intervention Type DEVICE

Activlink Phone Application

Smartphone tool used for monitoring location

Intervention Type OTHER

Other Intervention Names

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Location Monitoring Technology Location Monitoring Technology

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes