Alzheimer Dementia, Dementia, Vascular, Lewy Body Dementia With Behavioral Disturbance
Conditions
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.
Interventions
DEVICEActivlink 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.
OTHERActivlink Phone Application
Smartphone tool used for monitoring location
Sponsors
National Institute on Aging (NIA)
Aster Labs, Inc
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Activity Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Zarit Caregiver Burden Scale | 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. |
| AD Quality of Life Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Device Accuracy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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 |
| Care Partners Activlink Phone Application: Smartphone tool used for monitoring location | 3 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Pandemic caused suspension of study activities | 6 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Residents in Memory Care or Skilled Nursing Facility | Care Partners | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 0 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MiniMental State Exam | 18.8 units on a scale STANDARD_DEVIATION 3.8 | — | 18.8 units on a scale STANDARD_DEVIATION 3.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 3 Participants | 13 Participants |
| Region of Enrollment United States | 10 participants | 3 participants | 13 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 0 | 0 / 3 |
| other Total, other adverse events | 1 / 10 | 0 / 0 | 0 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 0 | 0 / 3 |
Outcome results
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 frame: week 2
Population: TIme reported by professional care giver spent in caring for monitored resident
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Partners | Caregiver Activity Survey | 305.7 minutes | Standard Deviation 177.5 |
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.
Time frame: up to 6 months
Population: No data were collected for this measure because nurse practitioners failed to complete the biweekly survey.
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.
Time frame: Up to 6 months
Population: No data were collected for this measure because the nurse practitioners failed to respond to the surveys biweekly.
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.
Time frame: First month of overall study period
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Residents in Memory Care or Skilled Nursing Facility | Device Accuracy | 87.83 percentage of observations |