An interventional study of Activlink insole and Activlink Phone Application in Dementia, Vascular, Alzheimer Dementia and Lewy Body Dementia With Behavioral Disturbance, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by University of Florida · Not applicable, Interventional, and Supportive care
Among 65 studies in Dementia, Vascular with a site in United States — 16 open to participants now, 20 under way, none of them phase 3. Dementia, Vascular · United States.
Among the 65 studies in Dementia, Vascular with a site in United States, this one is the 43rd largest by enrollment of the 47 interventional ones that give a count, is one of 8 that started in 2021, is one of 33 with no phase, and was the 20th registered.
183 studies on the registry are indexed under Dementia, Vascular; 44 are open to participants now.
Browse Dementia, Vascular studies →16 of the 65 studies in Dementia, Vascular with a site in United States are open now. Recruiting first, the newest first:
Hopeful Aging · Sites in United States
Ages 18–103 · Healthy volunteers
Hopeful Aging · Sites in United States
Ages 65+
Herrick Medical LLC · Sites in United States
Ages 50–100
Center for Clinical Studies, Texas · Sites in United States
Ages 18+ · Healthy volunteers
Jasmohan Bajaj · Sites in United States
Ages 65+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Dementia, Vascular studies recruiting now, 26 (72%) set no upper age limit and 2 (6%) stop at 75 or younger; 4 take children under 18; 14 take healthy volunteers.
This study: 21 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 5 · Phase 3 5 · Phase 4 2
First in 1995; this study’s year is marked. 8 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 123 across 116 interventional studies indexed under Dementia, Vascular.
Median enrollment 100 across the 47 interventional studies, 375 across the 17 observational. Of the 41 that completed or were terminated, 20 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 65 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,288 studies on the registry; 200 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 1 study filed under Dementia, Vascular — fewer than ten, so there is no comparison to draw.
10 of the studies in Dementia, Vascular with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06298474Hopeful AgingThe BRAIN App (Phase 2 SBIR) | 2026-11-30 |
| NCT06034509Walter Reed National Military Medical CenterCognitive and Vascular Functioning Following TBI | 2027-01 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT05704309Marinella TemprosaThe Diabetes Prevention Program Outcomes Study AD/ADRD Project | 2027-01-31 |
| NCT06079216Hopeful AgingMaking Connections Thru Music | 2027-04-29 |
Add all 10 to your calendar (.ics) → With an account.
Among the 65 studies in Dementia, Vascular with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Persons With Dementia Resides in memory care or skilled nursing
Persons With Dementia Resides in independent living setting in community.
Care Partners
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Activlink insole
Device: Activlink insole
Other: Activlink Phone Application
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.
Also known as: Location Monitoring Technology
Smartphone tool used for monitoring location
Also known as: Location Monitoring Technology
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.
Time frame: week 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.
Time frame: 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.
Time frame: up to 6 months
Device Accuracy
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
| Milestone | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners |
|---|---|---|---|
| Started | 10 | 0 | 3 |
| Completed | 2 | 0 | 3 |
| Not completed | 8 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Pandemic caused suspension of study activities | 6 | 0 | 0 |
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.
| minutes | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners |
|---|---|---|---|
| Caregiver Activity Survey | — | — | 305.7 ± 177.5 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| percentage of observations | Nurse Assistants Recorded Data From Residents in Memory Care or Skilled Nursing Facility | Partner Reported Data on Resident in Independent Living Setting | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting |
|---|---|---|---|---|
| Device Accuracy | 87.83 | — | — | — |
Collected over Full study period of 6 months for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Residents in Memory Care or Skilled Nursing Facility | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Resident in Independent Living Setting | — | — | — |
| Care Partners | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners |
|---|---|---|---|
| Accurate WiFi-Based Localization of Dementia Patients For Caregiver SupportProduct Issues | 1/10 | — | 0/3 |
Pandemic circumvented recruitment of independent living residents.
| Age, Categorical(Participants) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| <=18 years | 0 | — | 0 | 0 |
| Between 18 and 65 years | 1 | — | 3 | 4 |
| >=65 years | 9 | — | 0 | 9 |
| Sex: Female, Male(Participants) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| Female | 7 | — | 3 | 10 |
| Male | 3 | — | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 | 0 |
| Not Hispanic or Latino | 10 | — | 3 | 13 |
| Unknown or Not Reported | 0 | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 | 0 |
| Asian | 0 | — | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 | 0 |
| Black or African American | 0 | — | 0 | 0 |
| White | 10 | — | 3 | 13 |
| More than one race | 0 | — | 0 | 0 |
| Unknown or Not Reported | 0 | — | 0 | 0 |
| Region of Enrollment(participants) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| United States | 10 | — | 3 | 13 |
| MiniMental State Exam(units on a scale) | Residents in Memory Care or Skilled Nursing Facility | Resident in Independent Living Setting | Care Partners | Total |
|---|---|---|---|---|
| Mean | 18.8 ± 3.8 | — | — | 18.8 ± 3.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2021 to primary completion in May 2022, 16 months.
Results were first posted in May 2023, 11 months after primary completion.
Of 42 non-industry interventional studies with no phase under Dementia, Vascular, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 53. This study's 16 months is below that.
Counting every sponsor, half of 52 studies reached it within 35 months; a quarter within 25 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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