Social Support Aid For People With Dementia
Phase: PHASE2
Conditions: Dementia, Memory Loss
Sponsor: University of Minnesota

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PROTOCOL COVER PAGE 
Protocol Title 
Social Support Aid for People with Dementia 
Principal 
Investigator/Faculty 
Advisor 
Name: Joseph E. Gaugler 
Department: Division of Health Policy and Management 
Telephone Number: 612-626-2485 
Email Address: gaug0015@umn.edu 
Student Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
Nationally-based, federal funding organizations 
Version 
Number/Date: 
Version 2.0, May 8th, 2017 (updated in final version format for 
ClinicalTrials.gov, 3/16/22) 
NCT: NCT03645694 
 
 
 
 
 

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Table of Contents 
1.0 
Objectives ......................................................................................................................................... 5 
2.0 
Background ....................................................................................................................................... 5 
3.0 
Study Endpoints/Events/Outcomes ............................................................................................. 5 
4.0 
Study Intervention(s)/Interaction(s) ............................................................................................ 5 
5.0 
Procedures Involved ........................................................................................................................ 6 
6.0 
Data Banking .................................................................................................................................... 7 
7.0 
Sharing of Results with Participants ............................................................................................ 7 
8.0 
Study Duration ................................................................................................................................. 7 
9.0 
Study Population ............................................................................................................................. 7 
10.0 
Vulnerable Populations .................................................................................................................. 7 
11.0 
Number of Participants ............................................................................................................... 10 
12.0 
Recruitment Methods .................................................................................................................. 10 
13.0 
Withdrawal of Participants ........................................................................................................ 10 
14.0 
Risks to Participants ..................................................................................................................... 10 
15.0 
Incomplete Disclosure or Deception .......................................................................................... 10 
16.0 
Potential Benefits to Participants .............................................................................................. 11 
17.0 
Statistical Considerations ............................................................................................................ 11 
18.0 
Health Information and Privacy Compliance ........................................................................... 12 
19.0 
Confidentiality ............................................................................................................................... 15 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ................................. 16 
21.0 
Compensation for Research-Related Injury ............................................................................. 17 
22.0 
Consent Process ............................................................................................................................ 17 
23.0 
Setting ............................................................................................................................................ 17 
24.0 
Multi-Site Research ...................................................................................................................... 17 
25.0 
Coordinating Center Research.................................................................................................... 17 
26.0 
Resources Available ..................................................................................................................... 17 
27.0 
References ..................................................................................................................................... 18 
 

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ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
● SSA: Social Support Aid 
● PWMC: Person with memory concerns 
● RCT: randomized controlled trial 
● RA: research assistant 
 
 

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1.0 
Objectives 
1.1 
Purpose: Evaluate whether the Social Support Aid (SSA) exerts positive benefits for 
people with memory concerns’ (PWMCs’) social connections, communication, and 
quality of life via an embedded experimental mixed methods design that combines 
the collection and analysis of qualitative data within a traditional randomized 
controlled trial (RCT) design. 
2.0 
Background 
2.1 
Significance of Research Question/Purpose: See 
https://aging.jmir.org/2019/1/e13378/ 
2.2 
Preliminary Data: See https://aging.jmir.org/2019/1/e13378/ 
2.3 
Existing Literature: See https://aging.jmir.org/2019/1/e13378/ 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
Change in Dementia Quality of Life [Time Frame: Baseline, 3-months, and 6-months] 
The 21-item modified Dementia Quality of Life instrument is a self-report survey 
that assesses various domains of quality of life in the person wtih dementia. 
Change in Cantril quality of life ladder [Time Frame: Baseline, 3-months, and 6-
months] 
The Cantril quality of life ladder is a single item survey that asks respondents to rate 
their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the 
ladder). 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s):  
Pleasant events and activities of person with memory concerns [ Time Frame: 3-
months and 6-months ] 
The Pleasant Events and Activities-AD Schedule Short Form is a 17-item self-report 
survey that measures the degree of enjoyment persons with dementia have 
engaging in a range of activities. 
Change in the frequency and quality of social interactions of persons with memory 
concerns [ Time Frame: Baseline, 3-months, and 6-months ] 
Series of weekly, self-report calendar measures on types and quality of social 
interactions, developed for this study. 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
The social support aid technology consists of a smartphone with a facial recognition 
software application and a smartwatch. Up to 1,000 individuals can be enrolled in 

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the facial recognition application. Enrollment includes typing individuals names and 
relationships of the person with memory concern into the application and taking 
pictures of PWMC's faces at multiple angles. Once enrolled and in view of the 
smartphone's camera, the SSA's application recognizes the individual's face and 
alerts the smartwatch. The watch then vibrates and displays the individuals' name 
and relationship to the PWMC. 
5.0 
Procedures Involved 
5.1 Study Design:  
A parallel randomized controlled pilot trial design. 
5.2 Study Procedures:  
“Following completion of the baseline survey, participants were randomly assigned 
to either receive the technology or to continue with usual care. Participants were 
randomized at a ratio of 1:1 using a random number generator. Neither the 
participants nor researchers were blinded to randomization group. Research 
assistants met with participants in the intervention group in-person to provide the 
mobile phone and smartwatch and demonstrate how to use the SSA technology. 
Participants were given the technology to use at their discretion, and there was no 
requirement for how many times they had to use the SSA. Throughout the study, 
research assistants and the SSA developer provided technical support and answered 
questions regarding the technology. Participants in the control group were given the 
technology free of charge after completing the study.” (see 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715400/) 
5.3 Follow-Up 
“Data were collected at three time points: baseline, 3 months, and 6 months. 
Caregivers completed all surveys on behalf of the person with memory loss. 
Participants were asked for their opinion of their relative with memory loss (eg 
“How often does your relative feel confident?”). At baseline, surveys for participants 
caring for a person with memory loss measured ADLs, memory impairment, memory 
and problem behaviors, social interaction, and quality of life as well as demographic 
questions asking about themselves and the person with memory loss. Participants 
with memory loss who did not have a caregiver completed surveys on their own 
behalf. They received a slightly different version of the survey with questions being 
asked in reference to themselves (eg, “How often do you feel confident?”). Their 
baseline survey measured ADLs, memory impairment, social interaction, and quality 
of life as well as demographic questions about themselves. Surveys administered at 
3 and 6 months were identical to the baseline surveys except that they did not 
include demographic questions. At 3 and 6 months, participants in the intervention 
group completed an additional feasibility and utility checklist. Participants were 
given the option to complete an online or paper version of the surveys.” (see 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715400/) 

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5.4 
Individually Identifiable Health Information 
Survey data per above were relied upon. 
6.0 
Data Banking 
n/a 
7.0 
Sharing of Results with Participants 
7.1 Upon publication of the peer-reviewed manuscript summarizing the findings (see 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715400/; note that the 
publication is open access), the manuscript was emailed to all participants.  
8.0 
Study Duration 
8.1 Individuals participated in the study for up to 6 months. Participants were enrolled 
over a roughly 12 month period.  All study procedures were completed in roughly 24 
months. 
9.0 
Study Population 
9.1 
Inclusion Criteria: PWMCs must be: diagnosed by a physician with early-stage 
Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory 
loss; able to complete surveys in English or Spanish; SLUMS score of 20 or above. Care 
partners of PWMCs must be: 21 years of age and over; self-identify as someone who 
provides assistance to the PWMC because of their memory loss (these individuals are 
called ''care partners,'' as these individuals may or may not provide the intensive hands-
on care typical of ''caregivers''); and indicate a willingness to use the SSA 
9.2 Exclusion Criteria: Those who were not willing to utilize SSA. 
9.3 Screening: A research assistant screened potential participants over the telephone 
or via an online form to determine eligibility. 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
 
Population / Group 
Identify whether any of the 
following populations will be 
primary focus of the research 
(targeted), included but not the 
focus of the research or excluded 
from participation in the study.  
Children 
Choose an item. 

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Pregnant women/fetuses/neonates 
Choose an item. 
Prisoners 
Choose an item. 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Primary focus of the research 
Non-English speakers 
Choose an item. 
Those unable to read (illiterate) 
Choose an item. 
Employees of the researcher 
Choose an item. 
Students of the researcher 
Choose an item. 
Undervalued or disenfranchised 
social group 
Choose an item. 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Choose an item. 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Choose an item. 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Choose an item. 

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Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Choose an item. 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Choose an item. 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Choose an item. 
 
10.2 
Additional Safeguards:  
The experience of the University of Minnesota research team will minimize the 
possibility of psychological risks. The unlikelihood of such problems is evident from 
the absence of any clinically significant problems during the past eight years that 
Dr. Gaugler has operated various protocols related to dementia caregiving 
research. The RA will be trained to interview in ways that are non-threatening, 
friendly, and respectful. We will emphasize to all participants that they do not 
have to complete any question they do not want to answer, and that the interview 
may be terminated at any time according to their wishes. We will stress to care 
partners or PWMCs that their decision to discontinue the study will in no way 
affect the services they are receiving from the University of Minnesota or other 
entities. 
 
In the event a care partners or PWMCs does become upset during the interview 
process, the RA will contact Dr. Gaugler who will be available for consultation. If a 
participant is in crisis because of their care situation or some other reason, research 
staff will be instructed to consult with Dr. Gaugler. With the participant’s 
permission, we will then contact the appropriate resource person in an external 
agency (e.g., the Alzheimer’s Association). Based on the research team’s experience 
working with caregiving families, we expect no or very few such instances to occur. 
If a member of the research team does identify neglect or other potentially 
inappropriate care practices, the state Ombudsman will be notified to protect the 
rights of persons with dementia and their families. 
 

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10.3 If research includes potential for direct benefit to participant, provide rationale for 
any exclusions indicated in the table above: 
We believed participation in the SSA evaluation would yield benefits for 
participants. We hypothesized that the SSA would provide PWMCs with greater 
opportunity for social engagement and thus enhanced quality of life. 
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented: 48 participants consented for this study 
12.0 Recruitment Methods 
12.1 
Individuals with dementia, memory loss, or memory concerns, as well as their 
caregivers, were recruited from the University of Minnesota Caregiver Registry (a registry 
of caregivers who gave permission to be contacted about opportunities to participate in 
research), the Minnesota State Fair, and through statewide newspaper advertisements 
from February to October 2017. 
12.2 Recruitment Materials: Email and telephone scripts as well as flyers were used to 
recruit potential participants. 
12.3 Payment: Participants were offered $100 upon completion of the 6-month follow-up 
surveys/interviews. 
13.0 Withdrawal of Participants 
Per https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715400/: “A total of 58 potential 
participants were assessed for eligibility; of these, all but one met the inclusion criteria. 
Six of the 58 potential participants were unwilling to provide informed consent and were 
not included in the study. None of the participants expressed unwillingness to be 
randomized. Of the 48 participants that were randomized, 44 finished the study (92% 
retention rate). Two participants with memory loss refused participation after undergoing 
randomization to the intervention group. Two participants who were caregivers were lost 
to follow-up, both in the intervention group.” 
14.0 Risks to Participants 
The study had several risks: since the study involved no invasive procedures, we did not 
anticipate any physical risks to the family member or clients.  It was possible, although did 
not occur, when participants could have become upset with questions or thinking about 
the person with memory loss or their situations.  The potential social or legal risks for 
participants only related to possible violations of confidentiality which again did not occur. 
Given our data security procedures, we believed such risks were highly unlikely (we would 
estimate the likelihood of these risks at 5% or under). 
15.0 Incomplete Disclosure or Deception 
Not applicable  

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16.0 Potential Benefits to Participants 
16.1 Potential Benefits: There were no direct benefits to participants that were 
anticipated. 
17.0 Statistical Considerations 
17.1 
Data Analysis Plan From: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715400/.  
“Recruitment, Randomization, and Retention 
Chi-square and t tests were used to determine if participant demographics in the 
intervention and control groups were significantly different (P<.05). Chi-square and t tests 
were also used to compare participants who were lost to follow-up with those who were 
not. 
Feasibility and Utility 
Participants in the intervention group were asked to complete an additional survey at 3 
and 6 months to assess their perceptions of feasibility and utility. This checklist included 
15 Likert scale items asking participants to rate their level of agreement with statements 
such as “the technology works well,” “SSA was easy to use,” and “my relative felt lost 
using SSA” (ɑ=.89). 
 
Assessment of Intervention Effect 
Descriptive statistics were calculated for measures of quality of social interaction and 
quality of life. Social interaction quality was measured by asking participants to rate their 
satisfaction with the following types of communication: visits, phone calls, mail 
correspondence, and computer correspondence. Quality of life was measured using the 
Pleasant Events Schedule-Alzheimer’s Disease (PES-AD; frequency ɑ=.84; enjoyment 
ɑ=.76) and Dementia Quality of Life (DQoL; ɑ=.92). The PES-AD asks with what frequency 
and level of enjoyment the person with memory loss experiences a list of pleasant 
activities (eg, being outside, listening to music, laughing). The DQoL asks participants to 
use a Likert scale to rate how often the person with memory loss feels a certain way (eg, 
satisfied, cheerful, angry, worried). 
 
We imputed missing data using a Markov chain Monte Carlo method to conduct a five-
fold multiple imputation. Analyses were conducted as intention to treat. Change scores 
were calculated to determine differences between outcomes at baseline and 6 months. 
To determine whether changes in satisfaction and quality of life in the intervention group 
were significantly different than changes in the control group, t tests were used. Statistical 
significance was assessed using two-tailed tests with a significance level of P=.05. 
 

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Qualitative Analysis 
Following completion of the 6-month survey, participants in the intervention group were 
asked to participate in a semistructured interview; 13 individuals agreed to participate. 
The interviews took place over the phone and lasted between 10 and 30 minutes each. 
Interviews were transcribed by a professional service and organized into NVivo. 
Qualitative data were coded using Braun and Clarke’s [18] six steps of thematic analysis. 
HM first read through all transcripts and then generated initial themes. HM and JG 
discussed and compiled codes into an initial coding framework. Next, HM coded all 
material and revised the coding framework as needed. The qualitative analysis was guided 
by the research question: How and why did the SSA work or not work for caregivers and 
persons with memory loss?” 
17.2 Power Analysis: n/a 
17.3 Statistical Analysis: Please see section 17.1 above  
17.4 Data Integrity: Data cleaning and review of frequencies and other univariate 
procedures are used to ensure that the final analytic data sets are accurate. 
18.0 Health Information and Privacy Compliance 
Individually Identifiable Health Information: for guidance regarding the use, collection, storage 
and sharing outside of the covered entity of identifiable health information please see: UMN 
Privacy Office Policies and/or Fairview Health Services Privacy Policies, and UMN HIPAA 
Agreement Templates. For research conducted at Gillette Children’s Specialty Healthcare refer to 
Gillette Research Administration for guidance. 
Under the HIPAA Privacy Rule, research studies at the University are permitted to use and 
disclose protected health information with the authorization of the research participants, or 
without individual authorization in limited circumstances.  
18.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
x I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: Explain how you will ensure that only records of 
patients who have agreed to have their information used for research will be 
reviewed. 

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☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 
 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
x I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
If the limited data set used will contain information from somewhere other than the 
University of Minnesota or MHealth, then you must enter into a Data Use Agreement with 
the data source. You may use the University’s standard Data Use Agreement or another 
form approved by the health information Privacy & Compliance Office. Please upload in 
ETHOS the Data Use Agreement you will use for this transfer of information. 
If you do not have a Data Use Agreement in place, you may submit your protocol for 
review however, you must complete a Data Use Agreement before you can receive the 
Limited Data Set. If you have questions about Limited Data Sets, please refer to 
http://www.healthprivacy.umn.edu/policies-procedures/creating-limited-data-set, or 
contact the privacy office at (612)-624-7447, or by e-mail at privacy@umn.edu. 
☐ Other.  Describe: Describe in detail the source of the information. 
18.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 
All information was collected from surveys and interviews directly with 
participants who consented. See above for more information about how data were 
managed and secured. 

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18.4 
Approximate number of records required for review: 
Please see above 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
 
x Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants.  
Communication took place in-person, over the phone, and via email. 
18.6 
Access to participants 
Not applicable; participants were volunteers as detailed earlier. 
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the University’s Box Secure Storage (box.umn.edu) 

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 ☐ Store 
☐ Analyze 
☐ Share 
x In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
S:\Public_Health_Center-on-Aging_Gaugler\OLD P Drive\Social Support Aid for 
Persons with Dementia 
 x Store x Analyze 
x Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
HIPCO requires and will confirm that devices used in this manner are properly 
encrypted.  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other. Describe in detail the location and whether the data / specimens will be 
stored, analyzed, or shared, and in what ways. 
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartform (iPhone or Android devices) that you have not 
already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
18.8 Consultants. Vendors. Third Parties.  
Not applicable 
18.9 Links to identifiable data:  
All data sets from this study have been de-identified, so any link between names of 
participants and analytic data sets are no longer available. 
 
18.10 Sharing of Data with Research Team Members.  
We share and analyze data with research team members via the secure HST Citrix 
server/environment. 
 
18.11 Storage of Documents:  

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Please see above. Older completed studies, following study de-identification, are 
also stored in Mayo storage where appropriate 
 
18.12 Disposal of Documents:  
We do not plan to dispose documents. 
19.0 Confidentiality 
19.1 Data Security: Please see above for our steps to ensure confidentiality of all data as 
well as its security. The consent form is not located within any medical or similar 
record of participants.  
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
 
20.1 Data Integrity Monitoring.  
See below 
20.2 Data Safety Monitoring. As the proposed project will pose minimal risks to study 
participants the Principal Investigator (PI), Dr. Gaugler, will serve as the primary 
monitoring entity of this study.  As noted above, the proposed study involves no 
invasive procedures and there will be no physical risks to study participants. The 
consideration of need is potentially stressful, and thus there are possible 
psychological risks for the caregiver a relative with Alzheimer’s disease and related 
dementia (ADRD). The potential social or legal risks for the participants relate only to 
possible violations of confidentiality.  
Ongoing review of protocol and human subjects research compliance occurred 
during regular project meetings and Dr. Gaugler. During these meetings Dr. Gaugler 
worked with project staff to minimize research-associated risk and protect 
confidentiality of participant data. Research staff were trained to interview in ways 
that were non-threatening, friendly, and respectful.  We emphasized to all 
participants that they did not have to complete any question they did not want to 
answer, and that the interview could be terminated at any time according to their 
wishes.  We stressed to participants that their decision to discontinue the study 
would in no way affect the services they are receiving from the University of 
Minnesota or other entities. 
In the event a participant became upset during the interview process (which did not 
occur), research staff would contact Dr. Gaugler, who will be available for 
consultation.  If a participant was in crisis because of their care situation or some 
other reason, research staff were be instructed to consult with Dr. Gaugler (which 
again did not occur).  With the participant’s permission, we would contact the 
appropriate resource person in an external agency (e.g., the Alzheimer’s 
Association).  If a member of the research team identified neglect or other 

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potentially inappropriate care practices (which did not occur), the state Ombudsman 
will be notified to protect the rights of persons with dementia and their families.   
All information obtained from participants was strictly confidential and will not be 
released except at the express written request of the study participant. All electronic 
data are maintained on Dr. Gaugler’s office computer and the HST secure project 
folder.   
 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: Not applicable 
21.2 Contract Language: Not applicable 
22.0 Consent Process 
Note: The process and documentation plan must follow “SOP: Informed Consent Process for 
Research (HRP-090)” and “SOP: Written Documentation of Consent (HRP-091).” 
22.1 Consent Process (when consent will be obtained): Please see above. 
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception): Not 
applicable. 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained): Not applicable. 
22.4 Non-English Speaking Participants: Not applicable.  
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): Not applicable. 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: Please see above. 
22.7 Adults Unable to Consent: Please see above. 
23.0 Setting 
23.1 Research Sites: Please see above. 
23.2 International Research: Not applicable.  
23.3 Community Based Participatory Research: Not applicable.  
24.0 Multi-Site Research 
Not applicable. 
25.0 Coordinating Center Research: Not applicable 
26.0 Resources Available 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Social Support Aid for People with Dementia 
VERSION DATE: 5/8/2017 
 
Page 18 of 18 
Template Revised On: 11/1/2021      
26.1 Resources Available: Please see above for details on funding and other resources 
available to conduct this study, which is now complete. 
27.0 References 
McCarron HR, Zmora R, Gaugler JE. A web-based mobile app with a smartwatch to 
support social engagement in persons with memory loss: pilot randomized controlled 
trial. JMIR Aging. 2019 Jun 18;2(1):e13378.