Trial Outcomes & Findings for Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: (NCT NCT03360019)

Last Updated: 2023-05-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

week 2

Results posted on

2023-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Care Partners Activlink Phone Application: Smartphone tool used for monitoring location
Overall Study STARTED	10	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Care Partners Activlink Phone Application: Smartphone tool used for monitoring location
Overall Study Withdrawal by Subject	2	0	0
Overall Study Pandemic caused suspension of study activities	6	0	0

Baseline Characteristics

MMSE data collected on residents only not on staff

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Residents in Memory Care or Skilled Nursing Facility n=10 Participants 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.	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.	Care Partners n=3 Participants Activlink Phone Application: Smartphone tool used for monitoring location	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=10 Participants	—	3 Participants n=3 Participants	4 Participants n=13 Participants
Age, Categorical >=65 years	9 Participants n=10 Participants	—	0 Participants n=3 Participants	9 Participants n=13 Participants
Sex: Female, Male Female	7 Participants n=10 Participants	—	3 Participants n=3 Participants	10 Participants n=13 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	—	0 Participants n=3 Participants	3 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=10 Participants	—	3 Participants n=3 Participants	13 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) White	10 Participants n=10 Participants	—	3 Participants n=3 Participants	13 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	—	0 Participants n=3 Participants	0 Participants n=13 Participants
Region of Enrollment United States	10 participants n=10 Participants	—	3 participants n=3 Participants	13 participants n=13 Participants
MiniMental State Exam	18.8 units on a scale STANDARD_DEVIATION 3.8 • n=10 Participants • MMSE data collected on residents only not on staff	—	—	18.8 units on a scale STANDARD_DEVIATION 3.8 • n=10 Participants • MMSE data collected on residents only not on staff

PRIMARY outcome

Timeframe: week 2

Population: TIme reported by professional care giver spent in caring for monitored resident

Outcome measures

Outcome measures
Measure	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.	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.	Care Partners n=2 Participants Activlink Phone Application: Smartphone tool used for monitoring location	Resident in Independent Living Setting participants were not required to report on this outcome
Caregiver Activity Survey	—	—	305.7 minutes Standard Deviation 177.5	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: No data were collected for this measure because the nurse practitioners failed to respond to the surveys biweekly.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: No data were collected for this measure because nurse practitioners failed to complete the biweekly survey.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Residents in Memory Care or Skilled Nursing Facility n=9 observations 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.	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.	Care Partners Activlink Phone Application: Smartphone tool used for monitoring location	Resident in Independent Living Setting participants were not required to report on this outcome
Device Accuracy	87.83 percentage of observations	—	—	—

Adverse Events

Residents in Memory Care or Skilled Nursing Facility

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Resident in Independent Living Setting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Care Partners

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Residents in Memory Care or Skilled Nursing Facility n=10 participants at risk 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.	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.	Care Partners n=3 participants at risk Activlink Phone Application: Smartphone tool used for monitoring location
Product Issues Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support	10.0% 1/10 • Number of events 1 • 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.	— 0/0 • 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.	0.00% 0/3 • 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.

Additional Information

Glenn Smith

University of Florida

Phone: 352-273-6556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place