Dementia, VascularNCT03360019
Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:
A study testing Activlink insole and Activlink Phone Application in people with Dementia, Vascular and Alzheimer Dementia, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Vascular, Alzheimer Dementia, Lewy Body Dementia With Behavioral Disturbance
- What is being tested?
- Activlink insole and Activlink Phone Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Is not fluent in written or spoken English
- Indicate an unwillingness to use the Activlink
- History of Major Mental Illness for patient or caregiver
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oak Hammock Senior Living Center
Gainesville, Florida, 32608
Unversity of Florida
Gainesville, Florida, 32611
About this study
Official title: Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: Phase II
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.
Read the 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.
- Being tested
- Activlink insole, Activlink Phone Application
- Medical subject headings
- Dementia, Vascular, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activlink insoleDevice
Also called Location Monitoring Technology
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.
Activlink Phone ApplicationOther
Also called Location Monitoring Technology
Smartphone tool used for monitoring location
| Study group | Role | What they receive |
|---|---|---|
| Residents in memory care or skilled nursing Facility | Active comparator | Not described Receives: Device: Activlink insole |
| Resident in independent living setting | Active comparator | Not described Receives: Device: Activlink insole |
| Care Partners | Other | Not described Receives: Other: Activlink Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 2
Secondary outcomes (2)
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.
Measured: Up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start27 Jan 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia, VascularStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Aster Labs, Inc
- Responsible party
- Sponsor
- Investigators
- Glenn Smith, PhD, ABPP-cn, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360019
- Sponsor's protocol ID
- IRB201702352 -N -A
- Other IDs
- OCR17448, 5R44AG046944-03
- Status last verified
- May 2023
- First submitted
- 27 Nov 2017
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: Phase II
- ClinicalTrials.gov ID
- NCT03360019
- Acronym / sponsor ID
- IRB201702352 -N -A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Aster Labs, Inc
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Residents in memory care or skilled nursing Facility | Active comparator | Device: Activlink insole |
| Resident in independent living setting | Active comparator | Device: Activlink insole |
| Care Partners | Other | Other: Activlink Phone Application |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- Is not fluent in written or spoken English
- Indicate an unwillingness to use the Activlink
- History of Major Mental Illness for patient or caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activlink insoleAlso: Location Monitoring TechnologyDementia 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. | Device | Resident in independent living setting, Residents in memory care or skilled nursing Facility |
| Activlink Phone ApplicationAlso: Location Monitoring TechnologySmartphone tool used for monitoring location | Other | Care Partners |
Primary outcome
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.
2 secondary outcomes
Zarit Caregiver Burden Scale
Time frame: Up to 6 months
AD Quality of Life Scale
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dementia, Vascular
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Smith, PhD, ABPP-cn principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activlink insole and Activlink Phone Application in people with Dementia, Vascular and Alzheimer Dementia, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Activity Survey (time frame: week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.