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

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ClinicalTrials.gov Identifier: NCT03360019
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : February 3, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Aster Labs, Inc
Information provided by (Responsible Party):
University of Florida

Study Description
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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
Dementia, Vascular Alzheimer Dementia Lewy Body Dementia With Behavioral Disturbance Device: Activlink insole Other: Activlink Phone Application Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 27, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arms and Interventions
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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 Name: 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 Name: Location Monitoring Technology
Care Partners Other: Activlink Phone Application
Smartphone tool used for monitoring location
Other Name: Location Monitoring Technology


Outcome Measures
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Primary Outcome Measures :
  1. Caregiver Activity Survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360019


Locations
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United States, Florida
Oak Hammock Senior Living Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Leah Rae Watkins    352-318-2797    (lwatkins@oakhammock.org   
Principal Investigator: Glenn Smith         
Unversity of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Glenn Smith    352-273-6556    glennsmith@phhp.ufl.edu   
Principal Investigator: Glenn Smith         
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Aster Labs, Inc
Investigators
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Principal Investigator: Glenn Smith, PhD, ABPP-cn University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03360019    
Other Study ID Numbers: IRB201702352 -N -A
2R44AG046944-02 ( U.S. NIH Grant/Contract )
OCR17448 ( Other Identifier: OnCore )
5R44AG046944-03 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Lewy Body Disease
Dementia, Vascular
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Parkinsonian Disorders
 Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms