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| ID | Type | Description | Link |
|---|---|---|---|
| OCR17448 | Other Identifier | OnCore | |
| 5R44AG046944-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Aster Labs, Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Residents in memory care or skilled nursing Facility | Active Comparator |
| |
| Resident in independent living setting | Active Comparator |
| |
| Care Partners | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First month of overall study period |
Inclusion Criteria:
Persons With Dementia Resides in memory care or skilled nursing
Persons With Dementia Resides in independent living setting in community.
Care Partners
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Smith, PhD, ABPP-cn | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oak Hammock Senior Living Center | Gainesville | Florida | 32608 | United States | ||
| Unversity of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Residents in Memory Care or Skilled Nursing Facility | 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. |
| FG001 | Resident in Independent Living Setting | 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. |
| FG002 | Care Partners | Activlink Phone Application: Smartphone tool used for monitoring location |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Pandemic circumvented recruitment of independent living residents.
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| ID | Title | Description |
|---|---|---|
| BG000 | Residents in Memory Care or Skilled Nursing Facility | 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. |
| BG001 | Resident in Independent Living Setting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 reported by professional care giver spent in caring for monitored resident | Posted | Mean | Standard Deviation | minutes | week 2 |
|
Full study period of 6 months for each participant.
Care partners engaged only in observation and survey reporting and were not considered at risk for adverse events of any type including all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Residents in Memory Care or Skilled Nursing Facility | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support | Product Issues | Non-systematic Assessment | Discomfort with fit of product |
Participants from study 2A discontinued before the end of the intervention period, and caregiving nurse practitioners failed to respond to the surveys biweekly. Only 4 surveys were collected by the end of study 2A. Largely because of the Corona Virus 19 pandemic all contacted participants from study 2B declined or withdrew consent of baseline data collection and treatment implementation. Therefore, no data were collected for this phase of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Smith | University of Florida | 352-273-6556 | glennsmith@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2017 | Dec 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2021 | Feb 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Activlink Phone Application | Other | Smartphone tool used for monitoring location |
|
|
| 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. |
| up to 6 months |
| Gainesville |
| Florida |
| 32611 |
| United States |
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. |
| BG002 | Care Partners | Activlink Phone Application: Smartphone tool used for monitoring location |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MiniMental State Exam | Total score was used. Scores ranged from 0-30. A higher score indicates better cognitive functioning. | MMSE data collected on residents only not on staff | Mean | Standard Deviation | units on a scale |
|
| OG001 | Resident in Independent Living Setting | 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. |
| OG002 | Care Partners | Activlink Phone Application: Smartphone tool used for monitoring location |
|
|
| Secondary | 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. | No data were collected for this measure because the nurse practitioners failed to respond to the surveys biweekly. | Posted | Up to 6 months |
|
|
| Secondary | 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. | No data were collected for this measure because nurse practitioners failed to complete the biweekly survey. | Posted | up to 6 months |
|
|
| Other Pre-specified | 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. | In validation phase of study, Nursing assistants were sent intermittent prompts to compare location of resident as indicated by the device to actual physical location of patient as determined by direct observation. | Posted | Number | percentage of observations | First month of overall study period | observations | observations |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Resident in Independent Living Setting | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Care Partners | Activlink Phone Application: Smartphone tool used for monitoring location | 0 | 3 | 0 | 3 | 0 | 3 |
|
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| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| >=65 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| observations |
|