Back to resultsAccurate WiFi-Based Localization of Dementia Patients For Caregiver Support:
Primary Purpose
Dementia, Vascular, Alzheimer Dementia, Lewy Body Dementia With Behavioral Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activlink insole
Activlink Phone Application
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia, Vascular
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
Sites / Locations
- Oak Hammock Senior Living Center
- Unversity of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Residents in memory care or skilled nursing Facility
Resident in independent living setting
Care Partners
Arm Description
Outcomes
Primary Outcome Measures
Caregiver Activity Survey
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 Outcome Measures
Zarit Caregiver Burden Scale
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.
AD Quality of Life Scale
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.
Full Information
NCT ID
NCT03360019
First Posted
November 27, 2017
Last Updated
May 15, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Aster Labs, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03360019
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Aster Labs, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Vascular, Alzheimer Dementia, Lewy Body Dementia With Behavioral Disturbance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Residents in memory care or skilled nursing Facility
Arm Type
Active Comparator
Arm Title
Resident in independent living setting
Arm Type
Active Comparator
Arm Title
Care Partners
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Activlink insole
Other Intervention Name(s)
Location Monitoring Technology
Intervention Description
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
Other
Intervention Name(s)
Activlink Phone Application
Other Intervention Name(s)
Location Monitoring Technology
Intervention Description
Smartphone tool used for monitoring location
Primary Outcome Measure Information:
Title
Caregiver Activity Survey
Description
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.
Time Frame
week 2
Secondary Outcome Measure Information:
Title
Zarit Caregiver Burden Scale
Description
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.
Time Frame
Up to 6 months
Title
AD Quality of Life Scale
Description
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.
Time Frame
up to 6 months
Other Pre-specified Outcome Measures:
Title
Device Accuracy
Description
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.
Time Frame
First month of overall study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Smith, PhD, ABPP-cn
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oak Hammock Senior Living Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Unversity of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
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Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:
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