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Completed

NCT Number: NCT03360019

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

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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Key information

Conditions

Dementia, Vascular Alzheimer Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Dementia With Behavioral Disturbance Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oak Hammock Senior Living Center, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activlink insole

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.

Other names: Location Monitoring Technology

Activlink Phone Application

Other

Smartphone tool used for monitoring location

Other names: Location Monitoring Technology

Primary outcomes

  1. Caregiver Activity Survey

    Time frame: week 2

    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.

Secondary outcomes

  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. Total score was calculated. Scores ranged from 0-48 with a higher score indicating greater caregiver burden.

  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. Total score was calculated. Scores ranged from 13-52, with a higher score indicating better quality of life in caregivers.

Other outcomes

  1. Device Accuracy

    Time frame: First month of overall study period

    Percentage of physical checks where device displayed correct location of patient/resident. Only partners reported on the accuracy. No data were required from participants. Therefore, they were entered as 0s in the chart.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2017
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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