Clinical trial NCT03360019: Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:
Official title: Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Vascular
Alzheimer Dementia
Lewy Body Dementia With Behavioral Disturbance
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Aster Labs, Inc
First posted: 2017-12-02
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Activity Survey
timeFrame: week 2
Secondary outcomes:
measure: Zarit Caregiver Burden Scale
timeFrame: Up to 6 months
measure: AD Quality of Life Scale
timeFrame: up to 6 months
Other outcomes:
measure: Device Accuracy
timeFrame: First month of overall study period
Locations:
city: Gainesville
country: United States
facility: Oak Hammock Senior Living Center
state: Florida
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Glenn Smith, PhD, ABPP-cn
role: PRINCIPAL_INVESTIGATOR
References: