Utilizing Senior Companions to Enhance Dementia Care Services and Supports
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: University of Minnesota

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
Page 1 of 38 
Template Revised On: 6/25/2018 
 
PROTOCOL COVER PAGE 
 
 
 
Protocol Title 
Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase;  NCT03667924 
Principal 
Investigator/Faculty 
Advisor 
Name: Dr. Joseph Gaugler 
Department: 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: 
v15 / 10/28/22 
 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
Page 2 of 38 
Template Revised On: 6/25/2018 
REVISION HISTORY 
 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent Change? 
1 (Mod 
8452) 
Version 2: 
12/18/2018 
Updated Senior Companion 
baseline survey measures, 
office and data storage 
locations, language regarding 
incentive payments 
Yes 
2 (Mod 
9760) 
Version 3: 
3/14/2019 
Protocol review to align with 
intervention development and 
updated study procedures; 
Consent and procedure 
updates; addition of 3 new 
study staff 
Yes 
3 (Mod 
10054) 
Version 4: 
4/2/19 
Protocol review to align with 
intervention development and 
updated study procedures 
(screening, consent, delivery 
of training); update in study 
staff 
Yes 
4 (Mod 
10627) 
Version 5: 
5/2/19 
Protocol update for 
intervention 
development/delivery of 
training (allowing for 
facilitation of online CARES 
training in a group setting, 
sequence of study events) 
No 
5 (Mod 
11234) 
Version 6: 
6/4/2019 
 
Protocol update for change to 
consent (for PWML) and 
development of screeners, 
surveys, training evaluation 
Yes 
6 (MOD 
12402) 
Version 7: 
7/31/19 
Protocol update to allow for 
survey completion modality 
based on participant 
preference. Changes to 
eligibility screening process 
(inclusion of participants 
concerned about memory loss 
(no diagnosis), inclusion of 
clients from community 
setting, inclusion of LSS 
volunteer companions from 
No 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent Change? 
programs other than Senior 
Companion (such as Neighbor 
to Neighbor, etc.), and 
exclusion of caregivers/clients 
with untreated psychiatric 
disorders). Updated protocol 
modification dates to reflect 
submission dates. 
7 (MOD 
13796) 
Version 8: 
10/9/19 
Consent: GRA names removed, 
terminology updated to focus 
on “memory concerns”, 
monthly check-ins in person or 
via phone as able; Eligibility: 
added eligibility criteria of 
55+years for clients and 21+ 
years for volunteers and 
caregivers 
Yes 
8 
Version 9: 
12/27/19 
Protocol updated to: 
1. Reflect updates to 
“Permission to 
Contact” 
form/processes.  
2. Add that enrolled 
companions are 
provided a “checklist” 
reviewing project 
trainings and process 
for sharing information 
with clients  
3. Provide clarification 
that additional 
volunteer companions 
within the specified 
regions (previously 
stated as estimated 
n=20) may be enrolled 
as needed to meet 
client/caregiver 
recruitment targets 
4. Remove study 
milestones that are 
No 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent Change? 
identified to occur in a 
particular month of the 
study timeframe (as 
companions are 
enrolled on a rolling 
basis and follow up is 
administered per 
protocol accordingly) 
9 
Version 10: 
2/20/2020 
Update to screening criteria 
(AD8 to be used instead of 
TICS-M for client); addition of 
alternate version of assent for 
client participation with no 
surveys/interview; clarification 
of data collection measures 
based on survey modality 
 
Yes (added 
alternative assent 
for no 
surveys/interview) 
10 
Version 11: 
3/11/2020 
Update to screening 
procedures [client eligibility 
questions to be completed by 
caregiver if/when applicable]. 
Added option for volunteer 
baseline to be completed via 
phone as needed. 
 
11 
Version 12: 
3/22/2020 
Update to reflect project-
specific precautions related to 
COVID-19 and post-
bereavement procedures. 
 
12 
Version 13: 
6/17/2020 
No consistent 
use/administration of project 
milestones checklist (given 
COVID-related study 
modifications); removal of 
Community Advisory Board 
Meeting timeframes and 
criteria for study 
report/summary; updates to 
encrypted phone recording 
devices and transcription 
service; extension of COVID 
precautions through end of 
No 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent Change? 
study timeframe (August 
2020); update to timeframe 
for maintenance of study data 
13 
Version 14: 
8/10/2020 
Ensuring upload of 
intervention materials for 4-
part training  
 
14 
Version 15: 
10/28/22 
Study now completed; 
modification to update 
consistency of version date 
listed in header for 
ClinicalTrials; clarification of 
assent process 
No 
 
 
 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
Table of Contents 
 
1.0 
Objectives..................................................................................................... 8 
2.0 
Background .................................................................................................. 8 
3.0 
Study Endpoints/Events/Outcomes ............................................................. 9 
4.0 
Study Intervention(s)/Interaction(s) .......................................................... 10 
5.0 
Procedures Involved .................................................................................. 12 
6.0 
Data Banking .............................................................................................. 12 
7.0 
Sharing of Results with Participants .......................................................... 16 
8.0 
Study Duration ........................................................................................... 16 
9.0 
Study Population ........................................................................................ 16 
10.0 Vulnerable Populations .............................................................................. 18 
11.0 Number of Participants .............................................................................. 18 
12.0 Recruitment Methods ................................................................................ 21 
13.0 Withdrawal of Participants ........................................................................ 23 
14.0 Risks to Participants ................................................................................... 23 
15.0 Incomplete Disclosure or Deception ......................................................... 24 
16.0 Potential Benefits to Participants .............................................................. 25 
17.0 Data Management ..................................................................................... 25 
18.0 Confidentiality ............................................................................................ 25 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants ....... 26 
20.0 Provisions to Protect the Privacy Interests of Participants ....................... 27 
21.0 Compensation for Research-Related Injury ............................................... 31 
22.0 Consent Process ......................................................................................... 31 
23.0 Setting ........................................................................................................ 34 
24.0 Multi-Site Research .................................................................................... 35 
25.0 Resources Available ................................................................................... 35 
26.0 References ................................................................................................. 36 
 
 
 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
ABBREVIATIONS/DEFINITIONS 
 
ADRD: Alzheimer’s Disease and Related Dementias 
 
LSS-MN: Lutheran Social Service of Minnesota 
 
PCP: Primary Care Companion 
 
SC: Senior Companion 
 
SCP: Senior Companion Program 
 
PI: Principal Investigator 
 
DHR: Dementia Healthcare Research 
 
NIA National Institute on Aging 
 
NIH: National Institutes of Health 
 
LTSS: Long-Term Services and Supports 
 
PWML: Person with memory loss 
 
HCBS: home and community-based services  
 
RCP: Regional Program Coordinator 
 
LAR: legally authorized representative 
 
ISM: independent study monitor 
 
CAB: community advisory board 
 
CMSS: CARES® Memory Support Specialist 
 
 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
1.0 
Objectives 
This project will evaluate a novel adaption of the Senior Companion Program 
(SCP) administered by Lutheran Social Service of Minnesota to assist families 
better manage their relatives’ Alzheimer’s disease or related dementias (ADRDs); 
identify and facilitate use of community-based long-term services and supports 
(LTSS); and improve engagement with healthcare providers. This intervention, 
called the PorchLight Project has the following aims:   
Specific Aim 1. Implement PorchLight Project for 25 persons with ADRD or 
memory concerns (collectively, persons with memory loss [PWML]) and/or their 
caregivers in one urban and rural region of Minnesota. A convergent parallel 
mixed methods design [(QUAN+QUAL)-->QUAL] will be utilized to examine the 
feasibility, acceptability, and utility of PorchLight Project for 25 families and their 
SC-Ds (n = 20) over a 3-month period (i.e., Stage I of the NIH Stage Model). 
 
Specific Aim 2. Refine PorchLight Project delivery and implementation for 
efficacy evaluation. Activities to support this aim will include assessment of R61 
milestones and incorporation of R61 findings to refine the PorchLight Project 
prior to efficacy evaluation. Through stakeholder engagement with the Dementia 
Healthcare Research Advisory Group (DHR) as well as analysis of the various 
quantitative and qualitative data elements collected during this Phase, we will 
finalize and refine effective training approaches for PorchLight Project Senior 
Companions (SCs), identify and confirm stakeholder-centric measures, and 
enhance the overall implementation of the PorchLight Project to inform a 
subsequent R33 Phase. 
 
2.0 
Background 
The public health implications of Alzheimer’s disease or related dementias 
(ADRDs) are significant. Approximately 10% of Americans over the age of 65 
have ADRD, with this percentage escalating to 32% for those over the age of 
85.(1) The multi-year progression of ADRD has placed considerable pressure on 
the U.S. healthcare system, as persons with ADRD account for considerably 
higher healthcare costs than individuals without ADRD.(1-3) These concerns have 
led some to ask: how are we going to live with ADRD?(4, 5) 
 
Public health efforts to address ADRD are limited. The inability of formal 
healthcare systems to effectively identify ADRD and the lack of suitable care or 
case management often result in families remaining unaware of important 
community-based, long-term services and supports (LTSS) that could help to 
mitigate the negative effects of ADRD.(6, 7) Approaches that: a) identify 
community-residing older persons with potential memory impairment; b) assist 
their families in navigating the healthcare system; and c) facilitate the 
identification of appropriate community-based LTSS could result in more 
effective management of ADRD.(4, 8-10) 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Funded by the Corporation for National and Community Service, The Senior 
Companion Program (SCP) is one of three National Senior Service Corps 
programs. The SCP places volunteers in the homes of frail older adults to serve 
as companions, to provide assistance with activities of daily living, and to provide 
respite to family caregivers.(11-14) The SCP features 12,190 Senior Companions 
serving 43,000 frail older clients and 6,650 families throughout the U.S. in 
2017.(15) Although several efforts have attempted to utilize the SCP to develop 
psychoeducational, multi-session interventions for dementia family caregivers in 
smaller scale studies,(16) the use of SCP as a possible public health intervention 
to engage PWML, identify LTSS in the community, and facilitate healthcare 
system interactions is heretofore untapped. Utilization of lay/peer intervention 
providers in the community to reach older persons and their families who 
struggle with memory loss or ADRD may offer a novel, cost efficient method to 
reach those in need. Such an approach may also serve as a fulcrum around which 
formal healthcare delivery and community-based LTSS are better integrated for 
PWML and their families, which is a core tenet of effective chronic disease 
care.(17, 18) 
 
3.0 
Study Endpoints/Events/Outcomes 
 
Outcomes 
Primary:  
 Utilization of LTSS by PWML 
o Baseline, 1-month, 3-month 
o Community-based service utilization of PWML will be assessed by 
asking participants to identify (from a fixed list of options) fifteen 
different home and community-based services (HCBS). 
 Quality of primary care interactions  
o Baseline, 1-month, 3-month 
o A 3-item measure of quality of interaction during primary care 
provider encounters  
 Caregiver Distress: Burden 
o Baseline, 1-month, 3-month 
o Caregiver distress will be ascertained with the 22-item Zarit 
Burden Interview. 
 Caregiver Distress: Depressive symptoms 
o Baseline, 1-month, 3-month 
o Caregiver distress will be ascertained with the 20-item Center for 
Epidemiological Studies-Depression scale. 
 PWML Well-being 
o Baseline, 1-month, 3-month 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
o We will assess the PWML health related quality of life using the 
EQ-5D-5L. These measures will be used to generate the PWML 
health utility that will inform the cost-effectiveness analysis. 
 PWML Depression   
o Baseline, 1-month, 3-month 
o PWML Depression will be ascertained using the 15-item Geriatric 
Depression Scale Short Form 
 PWML Quality of Life  
o Baseline, 1-month, 3-month 
o PWML Quality of Life will be ascertained using the 13-item Quality 
of Life AD-Measure 
 
Secondary:  
o Caregiver self-efficacy 
o Baseline, 1-month, 3-month 
o An 8-item measure of caregiver self-efficacy. 
 
Note: Depending on time point, participants can elect to complete surveys in-
person, hard copy, or online. As needed, minor verbiage changes have been 
made to allow for online completion. 
 
4.0 
Study Intervention(s)/Interaction(s) 
 
Study Intervention 
Senior Companions (or other LSS-MN volunteers providing senior companionship 
services) who deliver the PorchLight Project will first complete the CARES® 
Dementia Care Specialist training modules developed by HealthCare Interactive. 
The CARES® interactive modules are designed to provide education, tools, and 
resources to help professionals from various disciplines as well as families 
provide more person-centered, effective care across the spectrum of ADRD. The 
CARES® modules are developed specifically for those with lower health literacy. 
The CARES® Approach is based on the following principles: C – Connect with the 
Person, A – Assess Behavior, R – Respond Appropriately, E – Evaluate What 
Works, and S – Share with Others. Among the unique and helpful features of the 
CARES® modules are care scenarios with real professionals, family members, and 
persons with ADRD as well as a wide variety of textual, audio, and visual 
resources, passive and active learning modes, interviews in streaming video, and 
resources for interactive feedback and interpersonal follow up.(19-24) Research 
supported by a series of Small Business Innovation Research grants authored by 
the Chief Executive Officer of Healthcare Interactive (John Hobday) and the PI 
(Joseph E. Gaugler, PhD) have demonstrated these modules’ strong feasibility, 
utility, and potential to inform practice change among diverse users.(19-24) 
Many states that require dementia-specific training for long-term care providers 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
recognize completion of the CARES® Dementia Basics module alone as a 
necessary training requirement. The Alzheimer’s Association also offers the 
CARES® modules as its essentiALZ® training certification program. 
 
Volunteer companions who deliver the PorchLight Project, as well as their 
Regional Program Coordinator (RPCs), will complete the first three modules of 
the CARES® program (Dementia Basics; Dementia-Related Behavior; Dementia 
Care for Families). Completion of the CARES® modules are self-paced, and can be 
completed individually or in a group setting. We will provide 20 tablets as 
needed to facilitate SCs’ training.  
 
In addition to the CARES training, SCs will be asked to complete four additional 
trainings provided by Dr. Gaugler’s team that will cover the following topics: 1) 
overview of the PorchLight Program, recruitment and approach, 2) Review of the 
National Consensus Guidelines on Palliative Care,(25) 3) Review of the list of 
guided questions, and 4) Review of journaling approach and LTSS resources. The 
National Consensus Guidelines on Palliative Care are evidence-based 
recommendations to provide a holistic palliative care model. For the purpose of 
our project, these guidelines will be adapted for the lay person delivering care 
(SCs). SCs will participate in these training sessions either in person or via web 
and/or teleconference. These sessions will offer the opportunity to integrate and 
demonstrate the learning obtained in the CARES® modules. CARES® reminders, 
resources, tips, and slides used for this training, along with space for note-taking, 
are provided in a binder and/or bag with the project logo. As needed, additional 
resources are given on request. 
 
After completing these trainings and passing a knowledge check exam (a score of 
90% or greater; the exam can be retaken at no additional cost if needed), SCs will 
receive a certificate of “CARES® Memory Support Specialist” (CMSS). 
 
The 3rd component of the PorchLight Project training will include monthly check-
ins (discussions and case review as applicable) with Senior Companions and the 
University of Minnesota (UMN) research team (the Principal Investigator/PI, 
research coordinator, or research assistant) via phone and/or in person. (26-
29)SCs who deliver the PorchLight Project will also be trained to identify 
community-based LTSS. A particular emphasis of SC engagement is to identify 
the strengths and needs of the PWML as well as their family caregiving system 
via semi-structured guides that assess elicit preferences for physical, family, 
social, cultural, financial/legal, and spiritual care. (28)  
 
Monthly check-ins will largely focus on review of specific cases (as applicable), 
discussion of challenges and potential solutions, provision of additional 
education as needed, and ensuring that SCs are regularly engaged with PWML 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
and family members throughout PorchLight Project delivery. We have 
successfully utilized this approach in a current national pragmatic trial that 
implements a staff-delivered family care management program in adult day 
service programs (“ADS Plus,” R01 AG049692; PIs: Gitlin and Gaugler). 
 
A project “checklist” will be available to enrolled companions as needed (offered 
during training or at monthly check in sessions) to facilitate completion of 
project training and the process for sharing information with their clients. 
  
5.0 
Procedures Involved 
 
A parallel convergent mixed methods design [(QUAN+QUAL)-->QUAL] will be 
used to generate qualitative and quantitative data on the feasibility and utility of 
the PorchLight Project across two Senior Companion Program (SCP) regions 
served by Lutheran Social Service of Minnesota (LSS-MN) (Stage I of the NIH 
Stage Model). The R61 procedure will begin with the project biostatistician, Dr. 
Roth, randomly assigning the 12 RPCs to one of two groups: a PorchLight Project 
“treatment” region or a SCP usual care region. A re-randomization procedure will 
be used to ensure balance between Regional Program Coordinators (RPCs) who 
are assigned to intervention or control conditions on 3 important regional/RPC-
level covariates: 1) whether the RPC has oversight within the Minneapolis-
St.Paul 7-county region; 2) whether the region includes 20 or more SCPs; and 3) 
whether the RPC has 3 or more years of experience in this position. The re-
randomization procedure has been used successfully in our ongoing ADS Plus 
trial (R01 AG049692). It involves conducting multiple possible randomizations 
(e.g. 20) before the trial is initiated, then selecting the one randomization 
assignment solution that achieves optimal balance on these pre-specified 
covariates. Two of the RPCs randomly assigned to a PorchLight Project treatment 
region will be randomly selected again to initially implement the proposed 
intervention: one from the Twin Cities metropolitan area and one from a region 
outside of the Twin Cities area.  
  
The 2 randomly selected RPCs and the volunteer companions under their 
supervision (estimated n = 20) will be invited to participate in this study after 
reviewing the PorchLight Project research procedures with them. Additional 
volunteer companions in the selected regions may be invited to participate as 
needed to meet the PWML and/or caregiver recruitment targets. If they 
voluntarily agree to participate, they will be asked to sign an informed consent 
form (hard copy or electronic), complete a baseline survey (hard copy, via phone, 
or electronic), and then undergo the training period.  The training features 
CARES® modules and the additional 4-part PorchLight Project training sessions 
delivered in person or via teleconference/web conference sessions described in 
the Research Plan. Following this training period, recruitment and enrollment of 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
PWML and their family caregivers in the PorchLight Project will begin. This will 
result in an anticipated sample of 25 PWML and/or their family caregivers.  
  
Following a description of the study by the SC, the UMN research coordinator or 
graduate research assistant would complete the screening process and 
consent/assent (similar to our other IRB approved protocols [e.g., 1401S47541]). 
Consent  would be reviewed with the research staff. The UMN research 
coordinator or graduate research assistant will administer a baseline survey to 
PWML. This can be conducted in-person, via telephone, or in hard copy. As 
applicable, the enrolled caregiver will also complete a survey. After completion 
of the baseline survey, the SC will engage with the PWML and caregiver to 
provide routine SCP respite and support in addition to: a) referral of the person 
with PWML and family member to recommended long-term services and 
supports (LTSS) in their community; b) assistance for the person with PWMLs 
and their family caregiver to navigate and interact with healthcare providers; 
and c) provision of guidance, support, and education/resources informed by in-
home visits or telephone consultations (i.e., the PorchLight Project). As part of 
the feasibility testing procedures, the volunteer companions will complete a 
usage log and journal entry following each contact with PWML and their family 
caregivers to summarize: a) the length and method of contact; b) the main issues 
that are raised by caregivers or PWML when receiving PorchLight Project 
support; c) types of support provided by the SC; and d) how family members and 
PWML react to/receive the various recommendations and services provided by 
the companion. A detailed list of procedures is listed below for each type of 
participant. 
 
The research team will utilize additional approaches to assess the feasibility and 
utility of the PorchLight Project implementation among 25 clients and family 
caregivers of PWML.  During the training period the standardized CARES® 
training program will be administered. Following the PorchLight training, an 
anonymous post-session satisfaction survey will be administered to assess the 
usefulness of the CARES® and PorchLight trainings and provide the companions 
with a forum to provide suggestions. We will also monitor turnover of SCs. A 
review checklist of the PorchLight Project, based on similar, reliable checklists Dr. 
Gaugler has used in his various dementia caregiving interventions will be 
administered to participating PWML and caregivers at 1 month and 3 months 
following completion of the baseline survey.  
  
Several data collection strategies will be employed to determine the degree to 
which participants use and apply the PorchLight Project service 
recommendations to their everyday care situations and how they perceive the 
utility of the PorchLight Project overall (see list below). The research coordinator 
or graduate research assistants will conduct a brief semi-structured interview 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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Template Revised On: 6/25/2018 
with PMWLs and/or their caregivers 3 months following baseline to explore how 
the application of the PorchLight Project was conducted. The open-ended 
responses will provide information about how PWML and/or their caregivers felt 
about volunteer companion visits and the resources they facilitated, and will 
point out how the program can be improved in the R33 Phase. A similar 
interview will be conducted with volunteer companions who implemented the 
PorchLight Project (estimated n = 20) to understand their experience in the 
project and suggestions for improvement. The interview will take place 3 months 
following the client/caregiver enrollment.  
 
List of procedures by type of participant [Note: Depending on time point, 
participants can elect to complete surveys in-person, hard copy, via telephone, or 
online. As needed, minor verbiage changes have been made to allow for online 
completion]: 
A. Volunteer companions: 
0) Assess eligibility  
1) Sign a consent form 
2) Complete a brief background survey 
3) Complete project training  
i. 3 CARES® modules (Basics, Behavior and Families) 
ii. Take the CARES knowledge check exam (re-take is optional 
at no additional cost)  
iii. 4-part project training in person or via web/teleconference 
1. “CARES® Memory Support Specialist” certificate 
4) Recruitment and enrollment of PWML and caregivers 
i. Use flyer, information sheets and Documentation of 
Permission Form  
5) 3-month work with client (intervention) 
i. Log of contact to monitor turn over   
ii. Journal 
iii. Monthly case review and check-in  
iv. Brief semi-structured interview 
B. PWML  
0) Assess eligibility, complete consent/assent (use UBACC to assess 
capacity to consent as necessary) 
1) If providing study team with data, PWML is asked to complete a 
survey at baseline, 1- and 3-months containing: 
i. Demographics/context of care [baseline only] 
ii. Cognitive assessment [baseline in-person only] – 5-item 
Mini Cog 
iii. Physical assessment [baseline in-person only]—Timed Up-
and-Go 
iv. Activities of daily living [baseline only] 

PROTOCOL TITLE: Utilizing Senior Companions to Enhance Dementia Care 
Services and Supports: R61 Phase 
VERSION DATE: 10/28/22; IRB Approved 11/1/22 
 
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v. Utilization of LTSS by PWML - Community-based service 
utilization of PWML will be assessed by participant identify 
(from a fixed list of options) fifteen different home and 
community-based services (HCBS). 
vi. Quality of primary care provider interactions - A 3-item 
measure of quality of interaction during primary care 
provider encounters 
vii. PWML well-being We will assess the PWML health related 
quality of life using the EQ-5D-5L. These measures will be 
used to generate the PWML health utility that will inform 
the cost-effectiveness analysis. 
viii. PWML depression – 15-item Geriatric Depression Scale 
Short Form 
ix. PWML quality of life – 13-item Quality of Life AD-Measure 
x. 15-item PorchLight Project Evaluation [1- and 3-months 
only] 
2) Brief semi-structured interview 
C.) Caregiver [if applicable] 
0) Assess eligibility, complete consent 
1) Complete a a survey at baseline, 1- and 3-months containing: 
i. Demographics, activities of daily living, memory 
impairment [baseline only] 
ii. Utilization of LTSS by PWML - Community-based service 
utilization of PWML will be assessed by asking family 
caregivers to identify (from a fixed list of options) fifteen 
different home and community-based services (HCBS). 
iii. Quality of primary care provider interactions - A 3-item 
measure of quality of interaction during primary care 
provider encounters 
iv. Caregiver Distress: Burden - Caregiver distress will be 
ascertained with the 22-item Zarit Burden Interview. 
v. Caregiver Distress: Depressive symptoms - Caregiver 
distress will be ascertained with the 20-item Center for 
Epidemiological Studies-Depression scale. 
vi. PWML well-being - We will assess the PWML health 
related quality of life using the EQ-5D-5L. Measures will be 
used to generate the PWML health utility that will inform 
the cost-effectiveness analysis. 
vii. Caregiver self-efficacy-An 8-item measure of caregiver self-
efficacy. 
i. 17-item PorchLight Project Evaluation [1- and 3-months 
only] 
2) Brief semi-structured interview 

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6.0 
Data Banking 
 
Release and Sharing 
N/A 
 
 
 
7.0 
Sharing of Results with Participants 
Since a variety of findings will be derived from the project, results will be 
disseminated via several mechanisms throughout the final months of the 
project. First, a user-friendly summary of the findings will be made available to 
all research participants and other key stakeholders such as the national office of 
Lutheran Social Service, the Dementia Healthcare Advisory Board, the Minnesota 
Brain Aging Research Consortium, the National Institute of Aging, and 
collaborating organizations that assist PWML and their family caregivers (e.g., 
the Alzheimer’s Association, the Family Caregiver Alliance, the Rosalynn Carter 
Caregiver Institute). The report will illustrate how community organizations and 
other long-term service and support (LTSS) providers can utilize the PorchLight 
Project model to effectively and proactively engage with persons with memory 
loss and their family members in the community. Dr. Gaugler will also be 
available to provide lectures and overviews of the results to interested 
organizations in Minnesota and in other regions of the U.S. (e.g., via Zoom web 
conference meetings).  
 
Multiple peer-reviewed manuscripts and presentations will also be produced 
from this study, and these academic dissemination efforts will be directed to top 
forums in gerontology, geriatrics, Public Health, and related disciplines. Clinical 
geriatrics and community-based health journals will also be identified for 
dissemination purposes in order to maximize the practice impact of this project 
and will create a strong foundation for subsequent scientific or service 
development efforts. To augment these resource sharing and dissemination 
activities, Dr. Gaugler will utilize social media to expand the reach of the project 
findings. Dr. Gaugler will post any scientific manuscripts, poster presentations, 
webinars, or final reports of the proposed project to his Experts@Minnesota 
profile site. The utilization of social networking and other Web 2.0 features will 
further dissemination both within and beyond the academic and service contexts 
of the project team. 
 
8.0 
Study Duration 
 
The total study duration will be 2 years. Volunteer companions will participate 
for approximately 12-16 months, depending on the number of eligible clients 
they identify. Volunteers may participate in study activities (including monthly 

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check in calls) through the end of the study timeframe in August 2020.  PWML 
and caregivers will participate for approximately 3-4 months.  
 
9.0 
Study Population 
The inclusion criterion for volunteer senior companions is to 1) be a current 
volunteer through LSS-MN 2) be willing to complete the CARES® modules and 4-
part training session provided by UMN research staff and 3) be 21 years of age or 
older.  
 
The inclusion criteria for the PWML will be based on one of the following 
scenarios: 1) the person or their caregiver are concerned about the person’s 
memory loss, 2) the person has a physician diagnosis of ADRD, 3) the caregiver 
(or PWML) scores 2 or greater on the  AD8,(30) a validated screening interview 
that includes 8 yes/no items. Note: The AD8 will be administered as needed, if 
other criteria had not been previously met in the discussion with the client and/or 
caregiver. The PWML must be 55 years of age or older. As needed, a caregiver 
may assist to provide data to determine a client’s eligibility. 
 
The inclusion criteria for the caregiver will be based on them caring for a PMWL 
at least in part related to their cognitive impairment. Their care recipient must 
be eligible per the inclusion criteria specified above. The clients/caregivers do 
not need to be receiving LSS services to be eligible. 
 
Further, a PWML or caregiver will be ineligible if they live with a current 
diagnosis of a serious psychiatric illness, their symptoms have worsened in the 
last 6 months, and they don’t receive steady, ongoing treatment for those 
symptoms.  
 
Inclusion criteria for the caregiver is that the individual is 1) 21 years of age or 
older, 2) self-identifies as someone who provides help to the PWML because of 
their cognitive impairments, and 3) the care recipient is eligible for the study as 
per the above criteria. 
 
To initiate participant recruitment, interested volunteer companions will reach 
out to the UMN study staff directly, or provide documented verbal or written 
permission to be contacted by UMN study staff. Following the volunteer’s 
enrollment and training, the volunteer companions, LSS staff, and/or UMN study 
team will present details about the study to clients and/or caregivers either in-
person (e.g., monthly meetings, at community outreach events) or over the 
telephone. If the client and/or caregiver agree, the SC, LSS staff, or UMN study 
staff person will record their verbal or written permission to be contacted by 
study staff using a hard copy or electronic form. Permission may also be 
obtained from community contacts interested in receiving senior companionship 

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(i.e., potential new clients). Alternatively, interested individuals may also contact 
the UMN research team directly to discuss the study.   
 
Following discussion with the interested individual, as applicable, the UMN team 
may reach out to the contact’s caregiver or care recipient without completion of 
an additional contact form. The UMN study staff will describe the study process 
in-depth to the client and/or eligible family caregiver and obtain signed 
consent/verbal assent to participate.   
10.0 Vulnerable Populations 
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
x 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 
☐ Approached for participation in research during a stressful 
situation such as emergency room setting, childbirth (labor), etc. 
x Disadvantaged in the distribution of social goods and services such 
as income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory 
standard treatments 
☐ Fear of negative consequences for not participating in the 
research (e.g. institutionalization, deportation, disclosure of 
stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase 
vulnerability to coercion or exploitation that might influence 
consent to research or decision to continue in research 
☐ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
      None of the above 
 
Additional Safeguards:  
In creating our research design and sampling procedures, an important objective 
was to preserve the privacy, confidentiality, and autonomy of all participants. 
Following discussion of the study with a volunteer companion, regional 
coordinator, and/or study staff, interested PWML and/or caregivers will be asked 
to provide permission to be contacted by study staff with more information. 

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Verbal permission will be recorded by LSS or UMN staff person using either a 
hard copy or electronic form. Alternatively, the potential participant may 
complete their own form or contact the UMN research team directly if they so 
choose. Study staff will reach out to introduce the study to the PWML, family 
caregiver [if applicable], and legally authorized representative (LAR) [if 
applicable]. If they are interested, staff will provide potential participants with 
the consent materials. Staff will review the consent materials in detail with each 
potential participant, including a description of the types of assessments to be 
obtained and time required.  
 
After reviewing consent with the PWML, staff will administer a capacity to 
consent questionnaire (San Diego Brief Assessment of Capacity to Consent 
[UBACC]),(33). If the PWML scores above the threshold for capacity to consent, 
they will be asked to consent to participate if they so choose. If the PWML scores 
below the threshold, they will be asked to verbally assent to participate if they so 
choose. (Note: Since the consent form was shared and/or reviewed with clients 
with memory loss prior to UBACC administration, staff would not review the 
assent form additionally (containing similar, but abbreviated information) prior 
to obtaining verbal permission regarding their interest in participation if they 
were unable to consent). In the case of PWML assent, signed consent will be 
obtained from the family caregiver or LAR. Participants who are eligible to 
consent will sign the consent form in electronic or hard copy. If the PWML scores 
below the threshold and does not have a caregiver or LAR, they are not eligible 
to participate in the study.  
 
Alternatively, if a caregiver is interested in enrolling in the project, and the client 
(or family) prefers that the client not complete data collection procedures 
(surveys/interviews), the research team will review an alternate assent form 
with the involved client, and enroll the caregiver separately. As needed (if the 
client does not participate in the full screening process separately), the research 
team may obtain data necessary to determine eligibility of the client from the 
involved caregiver or LAR. Additionally, if the eligible client is not participating in 
data collection surveys/interviews, the team would not assess the client’s 
capacity to consent (verbal assent for study involvement in this manner would 
be obtained). 
 
More details (and a diagram detailing the consent/assent procedures) are 
provided in the Consent Process section (22.0) below. 
 
Staff will review consent materials (and assent materials, if applicable) with all 
potential participants and give them the opportunity to ask questions. Potential 
participants may decide to review materials further and ask questions of staff 
and investigators at a time that is convenient to them. Participants who are 

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eligible to consent will sign the consent form in electronic or hard copy. In the 
case of assent, the process and the participant’s decision will be documented by 
study staff (no participant signature will be obtained). The study staff or Dr. 
Gaugler will also sign the hard copy consent form and/or assent form.  
 
The experience of the research team and the exclusion of participants with 
serious psychiatric illness 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 13 years that the research team has 
operated various protocols related to dementia caregiving intervention research. 
The research coordinator and research assistant 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 caregivers, PWML, and SCs that their decision to 
discontinue the study will in no way affect the services they are receiving from 
the University of Minnesota, Lutheran Social Service of Minnesota (LSS-MN) or 
other entities. 
 
In the event a caregiver or PWML does become upset during the interview 
process, the research coordinator or research assistant will contact Dr. Gaugler, 
who will be available for consultation. If a caregiver or PWML is in crisis because 
of their care situation or some other reason, research staff will be instructed to 
consult with Dr. Gaugler. With the caregiver’s PWML’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 
their caregiving families, we expect very few or no such instances to occur. If a 
member of the research team does identify neglect or other potentially 
inappropriate care practices, the Adult Protection office/officer will be contacted 
in the appropriate county.  
 
All information obtained from the participants will remain strictly confidential 
and will not be released except at the express written request of the study 
participant. All electronic data will be maintained on Dr. Gaugler’s office 
computer and an AHC-IS secure shared project folder. Per University of 
Minnesota and the Academic Health Center-Information Systems data security 
guidelines, all data for this project will only be accessed via this secure server. 
The data will be maintained on the secure project folder for approximately 3-5 
years, which is the time, anticipated it would take to disseminate all research 
papers or presentations from these data. Similarly, paper forms of the data will 
be located in a locked file cabinet in D351 Mayo Memorial Building (Dr. Gaugler’s 
research office) only accessible to the research team. Unless the data are being 
filed or accessed, these cabinets will remain locked. 

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We believe participation will yield benefits for participants. Participation in the 
PorchLight Project will provide PWML and their caregivers with improved ability 
to identify supportive, community-based services and better navigate healthcare 
systems for the PWML. Caregivers and PWML will be paid $25 following their 
successful completion of each survey and interview in the proposed study. Each 
enrolled caregiver and PWML is eligible for up to $100 in incentives.  
 
The evidence base of dementia caregiver interventions and dementia specialty 
care has advanced considerably, but linking PWML and their family members to 
available community-based LTSS remain underdeveloped. In particular, engaging 
with underserved persons with dementia and their families earlier in the disease 
process could help to improve caregiving outcomes, enhance community-based 
LTSS utilization, and assist families better navigate the healthcare system.  
 
We have attached the CHECKLIST: Cognitively Impaired Adults (HRP-417) to the 
ETHOS IRB application for further documentation of safeguards. 
 
COVID19 Precautions: 
 
The following precautions were implemented to promote the safety of 
PorchLight project participants and research staff during the COVID19 outbreak. 
Participants and new contacts affected by these precautions were notified. 
Precautions initiated March 2020 and will be continued through the end of study 
timeframe (August 2020). 
 
1.) Volunteer companion check-in meetings via phone/conference call only 
2.) Delayed (or incomplete) training for volunteer companions unable to 
complete training online  
3.) Volunteer companions not required to visit their client for research purposes; 
Routine client visits by LSS volunteers may exist per LSS discretion outside of the 
research collaboration. 
4.) Delayed enrollment of new volunteer companions for those unable to 
complete the process electronically/via phone 
5.) No enrollment of new PorchLight clients/caregivers. No in-person visits by 
study staff will be conducted during this time.  
6) Research team available via phone for project participants 
11.0 Number of Participants 
25 family caregivers and/or PWML; 20 SCs. 
 
12.0 Recruitment Methods 
For SCs:  

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The source of potential participants are current or new LSS-MN volunteer 
companions who express interest in the PorchLight Project. If they verbally agree 
to be contacted by the UMN research team, the person obtaining their verbal 
agreement (e.g., regional coordinator, LSS or UMN study staff, another Senior 
Companion, or the potential participant themselves) will document it, and the 
UMN research team will proceed to reach out to them to discuss the study 
further, as well as schedule a formal screening and consent process. Current SCs 
who undergo the training described above will then become “CARES® Memory 
Support Specialists (CMSS)”.  
 
For PWMLs and/or their caregivers: 
Potential participants will be initially identified by SCs, regional coordinators, 
and/or UMN and LSS study staff who engage with clients/caregivers. They may 
also share project information and obtain verbal permission to be contacted by 
those in the community interested in receiving companionship. SCs, regional 
coordinators, or UMN and LSS study staff will briefly describe the study, share a 
flyer and information sheet, and if the person agrees to be contacted by the 
UMN research team, record their verbal permission to be contacted using a hard 
copy or electronic form. Alternatively, the potential participant may complete 
their own form or contact the UMN research team directly if they so choose. 
Records of permission to be contacted will be transferred to the UMN research 
team in hard or electronic copy (e.g., via Qualtrics).  
 
As part of their volunteer roles, volunteer companions regularly meet with (in-
person or over the telephone) older persons to provide respite and support in 
their homes. The PorchLight Project is building off of this model to provide SCs 
with more specialized training and education in dementia and dementia care to 
better meet the needs of older persons they may be helping who have memory 
issues.  Volunteer companions, as part of their volunteer outreach role, will 
continue to engage with older persons to provide respite and relief (that is 
hypothesized as more effective based on their dementia care training), and as 
outlined in this protocol will present the opportunity to participate in the 
research project to these older persons.  If they agree to share their contact 
information with the UMN research team, we will then proceed to reach out to 
them to schedule a formal screening and consent process. 
 
All SCP clients that a SC may visit may be approached in regards to their 
participation in this project. Depending on the home situation of the SCP client, 
either the person with memory loss (PWML), the caregiver, or both will be 
approached. The SCs do not have to make a decision on who to approach; all 
screening for eligibility will take place by the UMN research coordinator or 
research assistants.  
 

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Note: Volunteer companions will be alerted by the project team if one of their 
clients enrolls in the project. 
 
SCs, regional coordinators, and/or UMN and LSS study staff will provide existing 
and potential new clients and/or caregivers with information on the PorchLight 
Project.  The UMN team will provide SCs, regional coordinators, and LSS study 
staff with study flyers/information sheets and forms they can use to record a 
client or caregiver’s verbal permission to be contacted by the UMN research 
team. The client or caregiver may complete their own form or contact the UMN 
research team directly if they so choose.  
 
Recruitment Materials 
We will be using flyers and information sheets describing the study. 
 
Payment 
Participating caregivers and/or PWMLs will also be asked to complete 1- and 3-
month outcome surveys (see below) and will be offered an incentive of $25 to 
complete the baseline, 1-month, and 3-month surveys, as well as a semi-
structured exit interview (for a total of $100 possible). 
 
13.0 Withdrawal of Participants 
 
Withdrawal Circumstances 
Participants would withdraw from the study if they indicate to the research 
coordinator they no longer wish to participate, either over the phone, email, or 
in writing. 
 
Withdrawal Procedures 
Our previous dementia caregiver intervention work at UMN has featured low 
loss to follow-up,(34-36) and we will take several similar steps to address 
attrition bias and enhance retention. If a PWML has died, caregiver follow-up 
interviews will include queries to determine when the event occurred. An 
enrolled caregiver, if applicable, would be asked to complete the next follow-up 
survey, as well as the final telephone-interview, in order to collect as much 
information on outcome variables that are appropriate (i.e., intention to treat 
principle, which is a feature of pragmatic trial design (37, 38)). Additional follow-
up surveys would be omitted. In instances where participants wish to withdraw 
from the study we will determine the reason for study withdrawal. All data 
collection/contact of these individuals will cease.  However, the research team 
will continue to use the data participants did provide in the intervals leading up 
to the decision to withdraw, per intention to treat principle. 
 
Termination Procedures 

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There is no intention to terminate any participant’s participation in the research 
study, however if this were to occur, the procedures that would be carried out 
would be similar to those if the participant requested to withdraw, or was lost to 
follow up. Data from participants who were terminated would be used up until 
the point of their termination.  
 
14.0 Risks to Participants 
Since the study involves no invasive procedures, 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. However, the research 
team has considerable experience providing psychosocial support to dementia 
caregivers on various protocols and serious psychological risks are unlikely to 
occur based on this experience. The potential social or legal risks for the 
participants relate only to possible violations of confidentiality. Given the 
procedures outlined below, such risks are highly unlikely. 
 
In creating our research design and sampling procedures, an important objective 
was to preserve the privacy, confidentiality, and autonomy of all participants.  
 
As indicated above, the experience of the research team and the exclusion of 
PWML and caregivers with serious psychiatric illness 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 13 years that the 
research team has operated various protocols related to dementia caregiving 
intervention research. The research coordinator and research assistants 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 caregivers, PWMLs, and 
SC-Ds that their decision to discontinue the study will in no way affect the 
services they are receiving from the University of Minnesota, Lutheran Social 
Service of Minnesota (LSS-MN) or other entities. 
 
In the event a caregiver or PWML does become upset during the interview 
process, the research coordinator or research assistant will contact Dr. Gaugler, 
who will be available for consultation. If a caregiver or PWML is in crisis because 
of their care situation or some other reason, research staff will be instructed to 
consult with Dr. Gaugler. With the caregiver’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 their 
caregiving families, we expect very few or no such instances to occur. If a 
member of the research team does identify neglect or other potentially 

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inappropriate care practices, the state Ombudsman will be notified to protect 
the rights of persons with dementia and their families.  
 
All information obtained from the participants will remain strictly confidential 
and will not be released except at the express written request of the study 
participant. All electronic data will be maintained on an AHC-IS secure server and 
data accessed by Dr. Gaugler or the project team will only occur via this server. 
The data will be maintained on the secure AHC-IS server for approximately 3-5 
years, which is the time, anticipated it would take to disseminate all research 
papers or presentations from these data. Similarly, paper forms of the data will 
be located in a locked file cabinet in D351 Mayo Memorial building (Dr. Gaugler’s 
research office) only accessible to the research team. Unless the data are being 
filed or accessed, these cabinets will remain locked. 
 
15.0 Incomplete Disclosure or Deception 
 
This study will not include incomplete disclosure or deception. 
 
16.0 Potential Benefits to Participants 
 
 
We believe participation will yield benefits for participants. Participation in 
the PorchLight Project will provide persons with dementia and their caregivers 
with improved ability to identify supportive, community-based services and 
better navigate healthcare systems for the PWML. Caregivers or PWMLs will be 
paid $25 following their successful completion of each survey and interview in 
the proposed study (for a total of $100 possible). 
 
17.0 Data Management 
 
Data Analysis Plan 
As this project will feature quantitative analyses that describe feasibility and 
utility of the PorchLight Project, the proposed sample size of 25 family caregivers 
of PWML (and/or PWML themselves) will be sufficient. As noted in various 
recommendations, a sample of 25 PWML (and/or their caregivers) and 20 SCs 
(estimated) who deliver the intervention is appropriate to ensure rich data 
derived for the semi-structured interviews proposed. Additional volunteer 
companions may be enrolled in order to reach the target sample of PWML 
and/or caregivers. 
 
As a major objective of this project is to examine the feasibility, acceptablity, and 
utility of the PorchLight Project intervention, quantitative analyses will large rely 
on descriptive statistics. Specifically, quantitative analyses will utilize frequency 
tables and means to examine sample characteristics and item-level responses to 
the PorchLight Project review checklist. Where appropriate, bivariate analyses 

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may also be conducted (e.g., paired T-Tests; Chi-square analyses) to examine 
factors associated with caregivers’ perceptions of utility and feasibility of the 
PorchLight Project at the 1- and 3-month follow-ups. Sex as a biological variable. 
The gender of the caregiver and PWML will be included to examine whether 
women or men caregivers and care recipients are more likely to indicate 
acceptability and utility of the PorchLight Project over a 3-month period in 
bivariate analyses. 
  
The multiple team meetings and discussions will allow for an exploration of 
alternative interpretations of the qualitative data and provide a check regarding 
the quality and richness of the data collected. Following the collection of all 
quantitative data and in preparation for analysis, all data are screened for 
outliers and normality and other data screening procedures will be employed as 
appropriate for the planned analysis. The research coordinator and research 
assistants will also follow up with participants if needed in instances of extensive 
missing data on surveys to ensure as complete data as possible. 
 
18.0 Confidentiality 
 
All information obtained from the participants will remain strictly confidential 
and will not be released except at the express written request of the study 
participant. All electronic data will be maintained on an AHC-IS secure server 
folder and a Box folder backup. Per University of Minnesota and the School of 
Public Health security guidelines, participant data will be maintained on the AHC-
IS secure project folder for approximately 3-5 years which is the time anticipated 
it will take to disseminate any and all research papers or presentations from 
these data. Similarly, paper forms of the data will be located in a locked file 
cabinet in D351 Mayo Memorial Building (Dr. Gaugler’s research office) only 
accessible to the research team. Unless the data are being filed or accessed, 
these cabinets will remain locked.  
 
The PI, research coordinator, and graduate research assistants will plan on 
creating a tracking file for the purposes of interview reminders and completion 
of the various data collection procedures. However, it is important to note that 
in the data analysis files, no identifying information will be entered or included. 
Any hard copy forms collected by LSS-MN staff (e.g., SCs) will be maintained in a 
locked file cabinet at LSS-MN and will be transferred securely to Dr. Gaugler and 
D351 Mayo at the conclusion of the project. SCs will be asked not to collect or 
record any personal health information on their clients. 
 
Similar to our other IRB-approved protocols, we will utilize a secure (or 
encrypted) telephone-based recording system to conduct semi-structured 
interviews. The XBlue X-7 or Olympus DS-2600 recording systems have the ability 

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to record both sides of a telephone conversation. The device connects to a 
computer for upload to a secure environment. The recordings are saved to the 
UMN Box Desktop App and the AHC-IS project server folder.  Recorded 
telephone interviews will be transcribed using Production Transcripts services. 
 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
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 in the Protection of Human Research Subjects 
section, 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 PWML or 
caregiver. However, potential participants with a history of serious mental illness 
(i.e., any major psychiatric disorder) will not be included in the study. 
Specifically, if a participant indicates they have clinical depression or a similar 
mental illness whose: a) symptoms have exacerbated in the last six months, and 
b) are not receiving steady, ongoing pharmacological or other treatment for 
these symptoms during the screening procedure, they will be excluded from our 
project. Further, since the research team has considerable experience providing 
psychosocial support to dementia caregivers on various research protocols, 
serious psychological risks are unlikely to occur. The potential social or legal risks 
for the participants relate only to possible violations of confidentiality. With 
respect to private information entered, the design of the system will include a 
structure of permissions with password protection to limit access to materials so 
only dementia caregivers and the research staff can view sensitive information.  
 
Additional monitoring support will be provided by the Independent Study 
Monitor (ISM), Dr. Tim Beebe, Mayo Professor and Head of the Division of Health 
Policy and Management in the University of Minnesota School of Public Health.  
 
A. Data and Safety Monitoring Procedures: Monitoring Study Safety 
B1. Monitoring study safety. In addition to ongoing review of the protocol and 
human subjects research compliance during weekly project meetings with staff, 
the PI (Dr. Gaugler) will generate annual reports to ensure that each case 
complies with Institutional Review Board (IRB) requirements, including use of 
IRB-approved forms (particularly the consent form), and that each staff person 
on the proposed project adheres to the study protocol. In both weekly meetings 
and audit reports, Dr. Gaugler will actively work with project staff to minimize 
research-associated risk and protect confidentiality of participant data (see 
Protection of Human Research Subjects section). The research coordinator and 
research assistants 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 

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interview may be terminated at any time according to their wishes. We will 
stress to PWML, their caregivers, and SCs who deliver the intervention that their 
decision to discontinue the study will in no way affect the services they are 
receiving from the University of Minnesota, Lutheran Social Service of Minnesota 
(LSS-MN), or other entities. 
 
In the event that a caregiver does become upset during the survey or interview 
process, the research coordinator or research assistant will contact Dr. Gaugler, 
who will be available for consultation. If a caregiver is in crisis because of their 
care situation or for some other reason, research staff will be instructed to 
consult with Dr. Gaugler. With the caregiver’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 their 
caregiving families, we expect very few or no 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. 
 
All information obtained from the participants will remain strictly confidential 
and will not be released except at the express written request of the study 
participant. All electronic data will be maintained on Dr. Gaugler’s office 
computer and the School of Public Health shared project folder. Per University of 
Minnesota and the Academic Health Center-Information Systems data security 
guidelines, all data on Dr. Gaugler’s AHC shared server are protected by strong 
passwords only accessible to Dr. Gaugler or the research team. The data will be 
maintained on Dr. Gaugler’s AHC server folder for approximately 3-5 years which 
is the time anticipated it will take to disseminate any and all research papers or 
presentations from these data. Similarly, paper forms of the data will be located 
in a locked file cabinet in D351 Mayo Building (Dr. Gaugler’s research office) only 
accessible to the research team. Unless the data are being filed or accessed, 
these cabinets will remain locked.  
 
B2. Annual audit reports. The responsibility of Dr. Gaugler (who also have 
oversight for the data management and analysis of the project) will include the 
production of an annual report that will highlight the results of the audit 
analysis, as well as study progress. In addition, Dr. Gaugler will provide 
information on any deviations from the approved protocol (e.g., deviations in 
adhering to study eligibility criteria), error rates, and any other issues related to 
the progress of the study. The ISM will review the audit report to ensure ongoing 
quality control, and will work with Dr. Gaugler, if needed, to ascertain if audited 
cases deviate from the approved study protocol. In instances of adverse events 
occurring (see below) the University of Minnesota IRB will be notified. 
 

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The audit reports will include the following: 
1. Table of contents 
2. Narrative/trial summary 
a. Summary of main findings 
b. Discussion of issues or problems 
c. Report preparation procedures 
3. Study description 
a. Project organizational chart, personnel 
b. Brief statement of purpose of trial 
c. Projected timetable and schedule 
4. Study administration 
a. Recruitment and participant status 
i. Table 1: Enrollment by year or month of study 
ii. Figure 1: Comparison of target to actual enrollment by 
month 
b. Forms status 
i. Status of forms (e.g., consent, completing of screener, 
baseline assessment battery, etc.) 
 
B3. Reporting Adverse Events and Unanticipated Problems 
In addition to ongoing monitoring of protocol and human subjects compliance 
and reporting and the production of annual case audits, Dr. Gaugler will 
generate safety reports on an ongoing basis that will list adverse events, serious 
events, unanticipated events, events related to or associated with the 
intervention, and the potential causality of the intervention to the event for each 
participant should they occur. Taken from the National Institutes of Mental 
Health policy on Data and Safety Monitoring in Clinical Trials and the Guidance 
on Reporting Adverse Events to Institutional Review Board for NIH-Supported 
Multicenter Trials (as suggested in the Policy of the National Institute of Nursing 
Research for Data and Safety Monitoring of Clinical Trials), the definition of each 
event is as follows: 
Adverse event. Any untoward medical occurrence in a patient or clinical 
investigation participant that does not necessarily have to have a causal 
relationship with the treatment. An adverse event can therefore be any 
unfavorable and unintended sign (including an abnormal laboratory 
finding, for example), symptom, or disease temporally associated with 
the use of [an intervention], whether or not considered related to the 
[interventions]. 
Serious adverse event. Any adverse experience that results in any of the 
following outcomes: death, a life threatening experience, inpatient 
hospitalization, a persistent or significant disability/incapacity, or a 
congenital anomaly/birth defect. Important medical events that may not 
result in death, be life threatening, or require hospitalization, may be 

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considered a serious adverse drug experience when based upon 
appropriate medical judgment, they may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
Unanticipated Problem. Any adverse experience, the specificity or 
severity of which is not consistent with the risks information described in 
the [protocol or consent documents]. 
Related to (or associated with) the intervention. There is a reasonable 
possibility that the experience may have been caused by the 
intervention. 
Causality. A reasonable possibility that the product is etiologically related 
to the adverse event. Causality assessment includes, for example, 
assessment of temporal relationships, dechallenge/rechallenge 
information, association with (or lack of association with) underlying 
disease, presence (or absence) of a more likely cause, plausibility, etc. 
 
In the instance of an adverse event, Dr. Gaugler will classify whether the event is 
unanticipated, adverse, or seriously adverse, whether the event is unanticipated 
or related to the intervention, and what potentially caused the event. Dr. 
Gaugler will review study-related data on an ongoing basis, will alert the 
University of Minnesota IRB as they occur, and will document adverse events in 
their annual report for the ISM and NIA program officer if these events occur. 
Specifically, Dr. Gaugler will utilize an adverse event form that will provide detail 
on the occurrence (who, what, when, where, why if relevant) of any adverse, 
serious adverse, unanticipated event/problem, and whether these events were 
related to participation in the proposed project. If adverse events occur during 
the R61 Phase of the project, the PI will review and report adverse events to the 
Institutional Review Board at the University of Minnesota. In our annual Data 
Safety and Monitoring Report, we will provide these adverse reports to the 
Independent Study Monitor to review and approve via a signed cover letter.  The 
final, approved Data Safety and Monitoring Report would then be sent to the 
Program Officer at NIA for review. 
 
B4. Procedures to Ensure Compliance with the Monitoring Plan across Study Sites 
Not applicable. 
 
B5. Assessment of External Factors  
Dr. Gaugler, via his own research experience as well as his editorial board 
service, is kept abreast of developments in ADRD caregiver interventions. This 
proximity to cutting-edge research on family caregiving interventions in addition 
to his regular review of the literature he conducts to support his various 
dissemination efforts will allow the research team to assess issues related to the 
delivery of community-based services and supports to PWMLs and their family 
caregivers. If such developments reveal any potential threats to participant 

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safety or other concerns that require protocol modification, these issues will be 
addressed in the annual audit reports provided to the ISM and the University of 
Minnesota IRB. 
 
B6. Plans for Interim Analysis 
There are no planned interim/futility analyses. Interim analyses are not planned 
because in the R61 Phase of this project, there is no randomly assigned control 
condition; the objective of the R61 Phase is to initially implement and refine the 
PorchLight Project’s  content, structure, and delivery where needed in preparation for 
the subsequent R33 Phase (years 3-5).  For these reasons, we did not deem futility 
analyses appropriate. 
 
20.0 Provisions to Protect the Privacy Interests of Participants 
 
Protecting Privacy 
As noted in the recruitment and enrollment process above, the University of 
Minnesota research team will not reach out to participants for screening or 
enrolling purposes unless those potentially interested share their permission to 
be contacted. 
 
All information obtained from the participants will remain strictly confidential 
and will not be released except at the express written request of the study 
participant. All electronic data will be maintained on an AHC-IS secure shared 
server. The data will be maintained on the  secure server  for approximately 2-3 
years, which is the time anticipated it will take to disseminate any and all 
research papers or presentations from these data. Similarly, paper forms of the 
data will be located in a locked file cabinet in D351 Mayo Memorial Building (Dr. 
Gaugler’s research office) only accessible to the research team. Unless the data 
are being filed or accessed, these cabinets will remain locked. Also, all 
correspondence that contains protected health information will take place via 
encrypted email, and the entirety of the research team will have completed 
HIPAA and CITI training prior to conducting human subjects research. 
 
Access to Participants 
Our research team is not permitted to access medical records. Any private 
information that the research team is allowed to have access to will need to be 
provided by the participant. This includes, but is not limited to, survey responses, 
semi-structured interview responses, and contact information. 
 
21.0 Compensation for Research-Related Injury 
This research does not involve greater than Minimal Risk to participants, so there 
is no compensation. 
 
22.0 Consent Process 

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In this study, we will adapt the consent process to fit the needs of each 
participant situation as detailed in the figure below.  
 
Briefly, clients and caregivers will be asked to consent individually. If a PWML is 
interested in participating, they will be asked to consent or assent depending on 
their capacity to consent and the availability of a caregiver or LAR. During the 
informed consent process, study staff will explain the project in detail including a 
description of the types of assessments to be obtained and the time required. 
Study staff will then administer a capacity to consent questionnaire for the 
PWML (San Diego Brief Assessment of Capacity to Consent [UBACC]),(33); if the 
PWML scores above the threshold for capacity to consent, they will be asked to 
sign the consent form if they  choose to participate. If the PWML scores below 
the threshold, then consent will be obtained from the LAR or caregiver and the 
PWML will verbally assent to study participation if they  choose to participate 
(UMN team will document that verbal permission was obtained via the assent 
form). If the PWML scores below the threshold and there is no LAR or caregiver 
involved, the PWML will not be eligible to participate.  
 
Alternatively, if a caregiver is interested in enrolling in the project, and the client 
prefers not to complete data collection procedures (surveys/interviews), the 
research team will review an alternate assent form with the involved client, and 
enroll the caregiver separately. In this scenario, the client’s capacity to consent is 
not assessed. The figure below reviews the study consent/assent procedures for 
clients (PWML) and their caregivers.  
 
 
 

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The participant will review the study consent form and will have the opportunity 
to ask questions prior to consenting. Study staff will review the assent form with 
the PWML if they score below the capacity score on the UBACC. Potential 
participants may also decide to review the consent/assent form further and ask 
questions of the staff and investigators at a time that is convenient to them. 
Study staff or Dr. Gaugler will also sign the consent form and assent form.  
 
Participants will identified through the Senior Companion Program (SCP) and 
other programs providing senior companionship services at Lutheran Social 
Service of Minnesota (LSS-MN), so we will rely on a combination of LSS-MN input 
and direct query of individuals to determine the LAR and their contact 
information.  
 

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Waiver of Written/Signed Documentation of Consent (when 
written/signed consent will not be obtained): N/A 
Non-English Speaking Participants: N/A 
Participants Who Are Not Yet Adults (infants, children, teenagers under 
18 years of age): N/A 
Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: Yes, please see above. 
 
Adults Unable to Consent 
Please see above. 
 
23.0 Setting 
Our research will be conducted at the University of Minnesota, School of Public 
Health, Division of Health Policy and Management, D351 Mayo Memorial 
Building, 420 Delaware St. S.E., Minneapolis, MN 55455.  
We will collaborate with a community partner, LSS-MN, to deliver the proposed 
intervention and identify participants for the study. These potential participants 
will be forwarded to Dr. Gaugler’s research team at the University of Minnesota, 
where they will then begin the process of eligibility screening. All research 
procedures will be conducted at the University of Minnesota, School of Public 
Health, Division of Health Policy and Management, D351 Mayo Memorial 
Building, 420 Delaware St. S.E., Minneapolis, MN 55455.  
 
A gap highlighted in the design, evaluation, and translation of dementia 
interventions is the lack of stakeholder engagement throughout the scientific 
process.(39, 40) Stakeholder engagement is important in the design, 
development, and evaluation of pragmatic trials. For these reasons, we will 
adopt various strategies outlined by AHRQ(41) and others to engage 
stakeholders to refine and enhance the implementation of the PorchLight 
Project’s for PWML and their family members. A Community Advisory Board 
(CAB) consisting of family members and care professionals, will offer stakeholder 
input.  
 
During periodic meetings (approximately 2 hours each), the CAB will review the 
aims to evaluate progress. Each meeting will also include time to discuss 
concerns so that as a group the DHR can propose mechanisms to resolve issues 
during the implementation and evaluation of the PorchLight Project. The 
philosophy underpinning the CAB meetings is one of balanced communication, 
mutual respect, and an interaction process where all viewpoints are heard and 
discussed openly. The UMN research coordinator or graduate research assistants 
will moderate and digitally record all meetings and interviews to provide an 
additional source of qualitative data on stakeholder perspectives. Open sharing 
of meeting transcripts with all CAB members to review and edit will also occur to 

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further establish a transparent environment. At the outset and throughout the 
course of the project, the CAB’s role as key collaborator on the PorchLight 
Project will be emphasized. The CAB meetings will serve to engage key 
stakeholders from different organizations, care specialties, and communities to 
further position the PorchLight Project as an innovative approach to assist PWML 
and their family caregivers.  
 
The CARES® interactive online modules (as previously described) are designed to 
provide education, tools, and resources to help professionals from various 
disciplines as well as families provide more person-centered, effective care 
across the spectrum of ADRD. The CARES® modules are developed specifically for 
those with lower health literacy. 
 
International Research: N/A 
 
Community Based Participatory Research: N/A 
 
24.0 Multi-Site Research: N/A 
 
25.0 Resources Available 
As part of his academic appointment in The School of Public Health, Dr. Gaugler 
will have the necessary time to devote to the proposed project. The teaching 
load is flexible and based on external support for Dr. Gaugler’s research time. 
Service expectations include standard membership on School of Public Health 
and university committees. Due to the advantageous research environment 
provided by The School of Public Health, Dr. Gaugler can devote up to 95% of his 
time to research projects and he will have the necessary effort available to make 
the current project a success.  
 
Dr. Gaugler’s secure suite in the Mayo Building includes his own office, three 
other connected office spaces, a meeting room, and a file area that house 9 of 
his research team members (e.g., two research coordinators, five graduate 
research assistants, and two additional research assistant). Dr. Gaugler’s office 
suites are equipped with secure computers (including the necessary statistical 
software), two printers (including one color), web cameras, telephone access, 
and ample secure file space to conduct the proposed study. The computers have 
LAN access. Dr. Gaugler’s suite is a private location to conduct research 
participant interviews when needed as well as collect and manage any related 
human subjects research data. 
 
In the event a caregiver does become upset during the interview process, the 
research coordinator or research assistant will contact Dr. Gaugler, who will be 
available for consultation. If a caregiver is in crisis because of their care situation 

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or some other reason, research staff will be instructed to consult with Dr. 
Gaugler. With the caregiver’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 their caregiving families, we 
expect very few or no 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.  
 
 
26.0 References 
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