Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
Phase: NA
Conditions: Dementia, Mild Cognitive Impairment, Alzheimer Disease
Sponsor: University of California, Berkeley

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers 
Phase IIB 
R44AG059458-03 
April 14, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pre-Screening Procedures:  
For Phase IIB, participants will be recruited through caregiver organizations, such as the 
Alzheimer’s Association. Recruitment efforts are aimed at the caregivers of individuals with 
neurodegenerative disease using three types of materials: (a) flyers, (b) a description of the study 
that was prepared originally for clinicaltrials.gov, and (c) a recruitment video. The video 
(approximately 2.5-minutes) describes this research study and introduces the in-home technology 
system. This video would be accessible in emails or online links provided by our research team 
to groups/organizations and caregivers who wish to learn more about the study. Caregiver 
groups/organizations may elect to embed the video link in newsletters, or show the video to 
interested caregivers who may qualify to participate. All recruitment materials describe the 
general nature and goals of the research and provide information about what participation 
involves and monetary compensation. The Berkeley research team is listed as the source for 
additional information and addressing questions in all materials. 
 
Initial Encounter: 
Potential participants will be caregivers of PWD and will recruited through online listservs of 
caregivers. Interested caregivers will be directed to an online website to learn more about the 
study, and complete a screening questionnaire to determine eligibility. Interested caregivers will 
also give their contact information for enrollment, as well as complete the consent to participate. 
Once a caregiver has enrolled through the website and been determined as eligible for the study, 
a member of the Berkeley Psychophysiology Laboratory team will assess the capacity of the 
PWD to give consent to be in the study. Once PWD consent is obtained either on their own, or 
through surrogate consent, participants will be sent a link to complete a set of questionnaires. 
Once patient consent is obtained, People Power will mail the Presence Caregiver system to the 
caregivers in the active condition for self-installation. People Power will be available to schedule 
virtual self-installation sessions if caregivers want by email or phone. Additional technical 
support for the system is available by email and phone during the course of the study.  
 
Caregivers who complete the IIB study in the control condition will be provided with an 
opportunity at the end of the 6-month study to receive a fully-functioning Presence Care system 
at no cost if they agree to complete questionnaires for an additional 6-month period(completing 
questionnaires at 9-months and 12-months). Participation is completely optional and caregivers 
who decline participation upon receipt of our group's email will not be penalized in any way. 
 
 
Consent:  
Participants will give consent online through the study website. Online consent requires 
participants to click on a box stating, "By clicking here, I indicate that I have read the above 
consent form and agree to take part in the research." Individuals receiving care (PWD) are asked 
to consent to participation as secondary subjects in order for information about them to be used 

for research purposes. In order to assess a patient's ability to consent to participation, a member 
of the research team will conduct a phone conversation with both caregiver and patient. The 
purpose of this conversation is to provide information about the study (e.g., participation 
responsibilities, compensation information, etc.) and to assess the PWDs cognitive capacity to 
consent for themselves using UCLA's "Decision-Making Capacity Assessment Tool.” More 
specifically, a member of the Berkeley research team will determine the PWDs ability to 1) 
understand relevant study information, 2) ability to appreciate the situation and consequences of 
the study, 3) ability to rationalize or reason information presented, and 4) ability to make their 
own decision to participate in the study. If the investigator’s evaluation is that the PWD can 
provide consent (i.e., the answer to questions 8 and 9 on the Assessment Tool are both “yes”) the 
PWD will be asked to complete their own consent form via Qualtrics. If the PWD is judged to 
have diminished capacity (i.e., the answer to questions 8 or 9 are “no”) then the caregiver will be 
asked to provide surrogate consent if the patient assents. Here, caregivers will be informed to the 
nature of their decision during the study including patient’s participation and decision to 
participate in certain procedures for the patient in order to ensure that the caregiver will be 
willing to undertake these on-going responsibilities. In addition, caregivers will be asked to 
identify a witness who will be willing to provide a bystander signature when they are completing 
the Self-Certification of Surrogate Decision Maker Form.  
 
Baseline Outcome Assessment:  
Once caregivers verbally understand and agree to these responsibilities they will be sent the 
surrogate consent form for the PWD, the self-certification of surrogate decision maker form, and 
their own consent form via a Qualtrics link. If the investigator’s evaluation is that the PWD can 
provide consent, the PWD will be asked to complete their own consent form via Qualtrics. Once 
all forms are completed, a link to the first questionnaire administration will be sent for the 
caregiver. Identical Qualtrics questionnaires will be sent via email to caregivers in both research 
conditions at baseline, 3 months, and 6 months. The three sets of questionnaires will be identical, 
except: (a) the baseline questionnaire will also include a contact information form and 
“Information about person receiving care”; and (b) the 3-month and 6-month questionnaires will 
also include questions regarding the usefulness of Presence Care in their homes.  
 
Randomization:  
300 caregivers will be randomly assigned to the "active in-home technology" condition of 
Presence Care and the remaining 100 caregivers will be assigned to the "waiting control" 
condition. Randomization of participants in each group will be determined by People Power 
employees after the consent process.  
 
Outcome Measures: 
All caregivers–regardless of randomized study condition–complete questionnaires on three 
separate occasions during this study: baseline, 3-months, 6-months. The four outcome measures 

are: (a) Zarit Burden Interview-Short Form, a questionnaire measuring caregiver burden (Zarit, 
Reever, & Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. 
Higher scores represent worse outcomes; (b) Center for Epidemiological Studies Depression 
Scale (CES-D), a questionnaire measuring depression (Radloff, 1977). 20 items are rated on a 0-
3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse 
outcomes. The clinical cut-off is usually set at a score of 16; (c) Beck Anxiety Inventory (BAI), a 
questionnaire measuring anxiety (Beck, Epstein, Brown, & Steer, 1988). 20 items are rated on a 
0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no 
subscales. A score greater than 36 is considered to be clinically significant; and (d) Satisfaction 
with Life Scale, a questionnaire measuring overall life satisfaction and well-being (Diener, 
Emmons, Larsen, & Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). 
Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores 
considered increasingly more satisfied and lower scores considered increasingly more 
dissatisfied.  
 
 
Contact initiated by study staff  
After completion of the first questionnaire and successful installation of the system, caregivers 
randomly assigned to the active condition will be mailed a check of $100. Qualtrics 
questionnaires will be sent via email to caregivers in both research conditions at baseline, 3 
months, and 6 months. Upon completion of the final questionnaire at 6 months, caregiver 
participants will be mailed a $50 check to compensate for their time completing questionnaires. 
A member of the research team will contact the caregivers to let them know they are welcome to 
uninstall and dispose of the system, or they may choose to keep any and all sensors, devices, or 
equipment in their home. For those who choose to keep equipment or devices, they will not be 
charged any cost and we will end our data collection of any related devices and will not ask that 
they complete any additional questionnaires regarding their usage of the system, sensors, or 
equipment (i.e., their participation in this study is complete). Caregivers randomly assigned to 
the waiting control condition will be mailed a check for $25 upon completion of the first 
questionnaire. After completion of the 3 and 6 month questionnaires, caregivers will be mailed a 
check for $50 and offered an opportunity to enroll in an additional 6-month study. If they enroll, 
they will be mailed the Presence Care system for them to self-install and have all sensors 
activated. They will also be asked to complete the questionnaires at 9-months and 12-months. 
Following the completion of this additional 6-month study, caregivers will be mailed a check for 
$125 for the 9 and 12 month questionnaires, as well as the installation to compensate for their 
time and effort.