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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03360019
Collaborator
National Institute on Aging (NIA) (NIH), Aster Labs, Inc (Other)
187
Enrollment
2
Locations
3
Arms
16.1
Anticipated Duration (Months)
93.5
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Activlink insole
  • Other: Activlink Phone Application
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
187 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
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.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)
Primary Purpose:
Supportive Care
Official Title:
Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: Phase II
Actual Study Start Date :
Jan 27, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Residents in memory care or skilled nursing Facility

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 Names:
  • Location Monitoring Technology

    		•
    Active Comparator: Resident in independent living setting

    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 Names:
  • Location Monitoring Technology

    		•
    Other: Care Partners

    Other: Activlink Phone Application
    Smartphone tool used for monitoring location
    Other Names:
  • Location Monitoring Technology

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Caregiver Activity Survey [Up to 6 months]

      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.

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oak Hammock Senior Living Center Gainesville Florida United States 32608
    2 Unversity of Florida Gainesville Florida United States 32611

    Sponsors and Collaborators

    • University of Florida
    • National Institute on Aging (NIA)
    • Aster Labs, Inc

    Investigators

    • Principal Investigator: Glenn Smith, PhD, ABPP-cn, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03360019
    Other Study ID Numbers:
    • IRB201702352 -N -A
    • 2R44AG046944-02
    • OCR17448
    • 5R44AG046944-03
    First Posted:
    Dec 2, 2017
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Dementia
    Alzheimer Disease
    Lewy Body Disease
    Dementia, Vascular
    Problem Behavior

    Study Results

    No Results Posted as of Feb 3, 2022