MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: Johns Hopkins University

MEMORI Corps: Activity-based 
Companion Care for Dementia 
NCT03896711
10/11/2023

IRB00197899 
Protocol Title: MEMORI Corps: A novel activity-based companion program to benefit community-living persons 
with dementia, their families, and senior volunteers 
Revision: V6, Date:10/13/2023 
Executive Summary 
This project adapts a novel activity-based companion care model (MEMORI Corps) for community-living 
persons with dementia for a virtual delivery format, and then implements the intervention in a pilot, two-arm, 
randomized controlled trial to evaluate intervention acceptability, feasibility, and preliminary efficacy versus an 
augmented waitlist control.   The goal of the program is to provide persons with dementia meaningful and 
individualized activity programming, dementia caregivers with support, information and respite opportunities, as 
well as provide health benefits, meaningful productive engagement, and peer support opportunities for senior 
volunteers. Core intervention components are derived and synthesized from Tailored Activities Program® , 
Experience Corps® and MIND at Home® and include: (1) detailed initial assessment of interests and 
preserved abilities of PWD; (2) individualized activity program plans based on interests and abilities; (3) 
training of volunteers in communication and simplification strategies and use of activity program plans; (4) 
delivery of activity plans by volunteers to PWD over 12 weeks (primary end point) (5 hours/week) from their 
homes; (5) family caregiver education on activity plans, activity engagement support, disorder education, and 
ways to utilize respite opportunities; and (6) support of volunteers from a skilled multidisciplinary team. 
The target group is 60 dyads (persons living with dementia and their informal co-residing caregiver) and 36 
companion guides (health volunteer 55 years of age and older).  Participants are randomized 1:1 either to the 
intervention or waitlist control group. Waitlist participants are offered the opportunity for cross-over into active 
intervention group. PWD/CG outcomes will be assessed at BL, 6-, and 12-weeks (PWD/CG participation lasts 
12 weeks). Volunteer Companion Guide outcomes will be assessed at baseline, 3-, and 6-months (Volunteer 
participation lasts 6 months). 
This model program could serve as an important new advancement for community-based long term care for 
PWD that addresses unmet patient- and family-centered needs through civic engagement of seniors. It could 
also serve as an intervention for dementia risk-reduction and brain health if found to be efficacious.  
Research Aims 
Aim 1:  Adapt and refine the MEMORI Corps intervention for a virtual delivery format using iterative user-
centered design principles and multiple stakeholder input.  
Aim 2:  Conduct a pilot, two-arm, randomized controlled trial to evaluate acceptability, feasibility, safety, and 
preliminary efficacy of the MEMORI Corps intervention (vs. wait list control group) in 60 community-living 
PLWD and informal caregiver dyads and 36 volunteer companion guides from geographically and 
demographically diverse regions in Maryland.   
Aim 3:  Evaluate the feasibility of ascertainment of community-living PWLD, caregiver, and volunteer-level 
outcomes over time using virtual and telephonic data collection methods.  
Overview of study design and procedures. 
This is a single blind, intention-to-treat, randomized controlled trial design to evaluate the feasibility and 
efficacy of a 12 week (12-weeks is the primary end point for PWD/CG outcomes), evidence-based, 
individualized MEMORI Corps program delivered by trained older volunteers (n=36) to community-living 
PWD/CG dyads (n=60).  Eligible PWD/CG dyads will be randomized to the intervention group (n=30), or 
augmented waitlist control group (n=30).  Intervention group PWD/CGs will be matched with a senior volunteer 
who will routinely engage and guide the PWD through virtual (and in some circumstances in-person) 
companion-guided MEMORI Corps activity programming for Weeks 1-12 (at least 5 hours per week of direct 
guidance/ companion engagement).  For the wait-list control group PWD/CGs after 12-week wait list period, 
the control group will receive the MEMORI Corps Companion guided activity the group for weeks 13-24 weeks. 

Outcome, process, fidelity, and acceptability measures will be collected at BL, 6 weeks, 12 weeks (primary end 
point), 18 weeks, and 24 weeks. Eligible volunteers (i.e. “Companion Guides”) will be randomized to 12 months 
of MEMORI Corps active duty (n=18) where they will be matched to three families over the course of a year, or 
a 6-month augmented waitlist control group (n=18) followed by opportunity to serve 6 months active duty in 
MEMORI Corps.  
PWD/CG design and procedures (Figure 4). PWD/CG dyads will be recruited through a multipronged 
outreach strategy, in partnership with community organizations, as done previously95  Referral dyads will 
complete a phone screen (e.g. explain study and procedures, determine demographic eligibility, confirm a CG, 
and screen for cognitive impairment/diagnoses).Those eligible, will receive an initial assessment (via 
telephone, JHU enterprise secure Zoom platform, or in-person—only if absolutely necessary) by study member 
study team (research interviewers) to obtain informed consent, confirm eligibility, collect information on 
baseline outcome measures for PWD and CGs (Table 5). PWD/CG dyads will then be randomized (within 2 
weeks) to either intervention or augmented waitlist. Intervention dyads will be referred to the Alzheimer’s 
Association for additional assessments, to create the individual activity plan (measures on 
Roles/Occupation/Interests, cognitive, physical, sensory, behavioral function, social orientation, daily 
routines/activities), and will be matched to a trained volunteer using a set of matching characteristics 
(geography, sex, age, occupation, interests, faith, and/or culture). The activity coordinator and matched 
volunteer will then jointly introduce the activity plan (e.g., provide a program orientation/rules, basic education, 
and teaching in use of activities) to PWD/CG dyad and begin implementation (Table 4). The volunteer will then 
conduct routine, semi-structured companion sessions using the activity plan for the remainder of the 12-week 
program virtually via Zoom platform or in a hybrid virtual/in-person format (5 hours per week).   CGs will 
receive a written copy of PWD activity plan, and written educational/coaching materials on various topics (bi-
weekly).    Augmented waitlist dyads (control group) will be offered an opportunity for participation in the 
intervention arm at 12 weeks. Evaluators masked to group allocation will assess all dyads at 6-weeks (T2), and 
12-weeks (T3) (the main trial endpoint). This assessment schedule is consistent with outcome measurement 
intervals on behavioral and caregiver burden in TAP trial. Willing and eligible wait-list dyads will then receive 
MEMORI Corps Companion-Guided activity programming (weeks 13-24). PWD and CG will each receive $20 
for each study assessment (T1, T2, T3, T4, T5, ).  
Figure 4. Study Flow and Randomization for PWD/CG 
 
Enrollment (Virtual) 
Randomization (1:1) 
Stratified by CG relation (spouse vs. non-sp), 
MoCA >10 vs. <10, prior dementia study past 12 
months 
Companion Guided 
MEMORI Corp 
Intervention  
(n=120) 
Augmented Waitlist  
(n=120) 
 
6 week follow-up 
(T2) 
12 week follow-up 
(T3) 
 
 
6 week follow-up 
(T2) 
12 week follow-up  
(T3) 
Begin Uniper Only 
Self-guided 
 
18 week follow-up (T4) 
24 week follow-up (T5) 
Study Completed 
Companion Guided 
MEMORI Corps  
24 week follow-up 
(T5) 
18 week follow-up (T4) 

Senior volunteer design and procedures (Figure 5) . Senior volunteers will be recruited through a 
multipronged outreach strategy, in partnership with community organizations as the PWD/CG.  Referrals will 
complete an initial screen for core eligibility (e.g. explain study and procedures, determine demographic 
eligibility, screen for cognitive impairment/diagnoses, IADL/ADL function, basic literacy screen). Those eligible, 
will be invited to a virtual meeting followed by oral consent and baseline assessment (via telephone, JHU 
enterprise secure Zoom platform, or in-person—only if absolutely necessary) by study member study team 
(research interviewers) (Table 5). Following a an adapted methodology originally developed in the Experience 
Corps program A group of senior volunteers (n=36, age 55 years or older) will be recruited in several, 
staggered cohorts through a multipronged outreach campaign involving community partner organizations (e.g. 
Alzheimer’s Association, AARP Maryland), and general and targeted community outreach.  Interested 
volunteers will contact JHU and will be screened by the JHU study staff, taking part in a three step recruitment 
process (Figure 5) that includes (1) an initial description of the program and core eligibility screening (age, time 
commitment, motivation) by phone, (2) a virtual informational meeting hosted jointly by the Alzheimer’s 
Association and Johns Hopkins (full information including goals, commitment, randomization and study 
assessments, Q&A), and (3) obtain informed consent by phone/in-person￼￼, and collection of baseline 
measures (Table 5).  Volunteers will then be randomized to either MEMORI Corps active duty intervention (12-
months) or Augmented Waitlist Control. Intervention volunteers will then be referred to the Alzheimer’s 
Association and undergo several more intake steps: (4) they will receive an extensive MEMORI Corps training, 
(5) and a criminal background check,  and health screening, followed by (6) matching to their first PWD/CG 
dyad, facilitated by the study OT. This 6-step intake process is in part designed to reduce attrition and enroll 
only those who would likely be able to fulfil the high intensity commitment.   Over the 12 month period of 
service, each volunteer will be 
matched to about three different 
PWD/CG families (only working 
with one at a time), spending 12 
weeks with each one.  The 
remaining 3 months of the service 
period will be time off (flexible schedule, coordinated with the Volunteer Coordinator at the Alzheimer’s 
Association). In addition to the 5 hours per week volunteers spend with PWD, they will also spend 1 hours per 
week in a team meeting with peer volunteers (equaling a total of 6 hours per week of active service). 
Volunteers (when matched to PWD) will receive a monthly stipend of $200/month (taxable) similar to￼￼  
Augmented wait-list volunteers will be offered an opportunity for participation in the intervention arm at 6 
months. All volunteers will have outcomes assessed by masked evaluators at 6-months (T2) (the main trial 
endpoint), and 12-months (T3) (Figure 5).  This assessment schedule is consistent with outcome measurement 
intervals on physical function, cognition, and engagement in Experience Corps trials. Willing and eligible wait-
list volunteers will then cross-over into the intervention arm, and following the same procedures for intake 
described earlier, will commit to 6 months of MEMORI Corps program active service, with outcomes assessed 
by masked evaluators at 6-months (T3) post intervention initiation. Volunteers who have successfully 
completed 12 months of service, and desire to commit to another 12 months of service will be allowed (within 
the time frame of the study). Time served in the program and number of PWD/CG dyads matched will be 
tracked for each volunteer. Volunteers will each receive $20 for each study assessment. 
Recruitment, Enrollment and Randomization.  PWD/CG dyads (n=60) will be recruited throughout all 
counties in Maryland and Baltimore City.  (catchment area). To ensure we meet our sample size requirements 
and the study participants from diverse backgrounds and diverse geographic regions, we will use and 
Figure 5. Study Flow for Volunteers 

extensive multipronged outreach campaign that includes mailings/eblasts/referrals through aging services 
providers and community organizations (e.g. religious organizations, senior housing, health providers, social 
services agencies, aging resource agencies, nutritional services), a variety of recruitment materials in different 
media formats, a variety of recruitment sites (e.g., Johns Hopkins Community Physicians, Johns Hopkins 
Home-Based Medicine (JHOME)).  We may also use social media opportunities/platforms such as podcasts 
and livestream sessions and targeted media briefings (e.g., Kaiser Health News, WashPo, NPR/WAMU, 
Beacon, Next Ave, others) to raise public awareness of the science to date on the topic related to brain health, 
social and activity (which relates to the COVID pandemic), and to provide contact/descriptive information on 
the MEMORI Corps trial as a way to highlight that research is currently ongoing on this topic. We may also 
work with the Maryland Department of Health IRB (as we have in the past for IRB00054802) to obtain 
permission to work with state agencies and aging programs and local health departments to assist in 
outreaching to potentially eligible clients (such as those in Caregiver Support program or on the Medicaid 
Waiver Waiting lists) as well as more generalized community outreach (e.g. radio advertisements, event 
participation). 
Senior volunteers (n=36) will be recruited through a multipronged outreach campaign too involving 
mailings/eblasts by community and partner organizations (e.g. Alzheimer’s Association, AARP Maryland, other 
senior advocacy organizations, religious organizations, senior housing, continuing care communities, senior 
centers) and general and targeted community outreach (e.g. events/health fairs/seminars, publicity/media, paid 
advertisements/marketing), following established methods.51,69,101 The Alzheimer’s Association and Johns 
Hopkins will co-lead the outreach campaign. Potentially eligible senior volunteers will be screened by the 
Hopkins team (Steps 1-3, Figure 5), and if eligible will be randomized into either the Intervention or Waitlist 
Control group. The Intervention group will be referred to the Alzheimer’s Association (who will lead all volunteer 
operations for this project) for onboarding, intake, and matching (Steps 4-6, Figure 5). The Hopkins 
evaluation/interview team will conduct separate masked outcomes assessments for all enrolled volunteers. We 
will work closely with the Alzheimer’s Association and AARP’s Baltimore Experience Corps, who will provide 
“know how” through their extensive volunteer recruitment, training, management, and retention experience. To 
ensure the supply of trained volunteers (with a 25% reserve pool to account for time off/illness/attrition) will 
match the PWD/CG enrollment rates (8 per month), volunteers will be enrolled/randomized in four staggered 
cohorts, 20 per group (a critical mass).  
Replacement Rule: Participants will be replaced if for any reason they become ineligible, unavailable, or 
unwilling to participate up to the date they are randomized. Randomization: We will use dynamic 
minimization102 to ensure that dyad study arms are balanced with respect to CG relationship (spouse/non-
spouse), MMSE>10, and participation in a different dementia study in the previous 12 months 
(yes/no).  Software to perform this type of minimization has already been developed and used by our research 
group in clinical trials (e.g. MIND at Home).  A similar procedure will be used to randomize volunteers, which 
will balance arms on sex and dementia caregiving experience. 
Intervention (MEMORI Corps). This activity-based companion care program for PWD is delivered by trained 
senior volunteers, supported by a clinical team, over a 12-week intervention period (5 hours per week, 4-5 
days per week) for each PWD/CG dyad. Primary roles of the volunteers are to provide peer-to-peer 
companionship, and an individualized activity program that focuses on meaningful, engaging and enjoyable 
activities that match PWD abilities and interests and covers broad domains (physical activity, cognitive 
engagement/stimulation, and social engagement).  Program goals are to provide persons with dementia 
meaningful evidence-based activity programming, provide family caregivers with support, education and 
respite opportunities, as well as provide health benefits, meaningful productive engagement, and peer support 
opportunities for senior volunteers.  Core elements:  Intervention components are derived and synthesized 
from Tailored Activities Program (TAP)®, Experience Corps (EC)® and MIND at Home®  (Table 1) and include: 
(1) a detailed initial assessment of interests and preserved abilities of PWD, (2) individualized Activity Plans 
created by trained Activity Coordinator; (3) initial training of volunteers in the use of activity program plans, 
dementia education, communication and simplification strategies, and environment setup; (4) delivery of 
activity plans by volunteers to PWD over 12 weeks (5 hours/week) in their homes; (5) family caregiver 
education on activity plans, dementia, and ways to utilize respite opportunities; and (6) support of volunteers 
from a skilled multidisciplinary clinical team. Process: Once a PWD/CG dyad has been randomized to 

intervention arm, the individualized program is developed and implemented in three phases—Assessment and 
Activity Plan Development, Orientation and Instruction, Implementation (see TABLE 4). It relies on adaptation 
of the well-developed, manualized TAP protocols that have been previously tested in trials and adapted to a 
variety of settings/cultures/interventionists.  Activity plans will be semi-structured weekly schedules with 4-5 
sessions designed for 1-1.5 hours sessions and will consist of a combination of (a) one-on-one social and 
activity time between PWD and Volunteer, (b) physical activities, (c) group-based live social activities (e.g., live 
chair Yoga sessions), and/or (d) cognitively engaging activities (e.g. virtual Baltimore art museum tour, Trivia). 
Challenges and emergent issues faced by volunteers, PWD, or CG will be reviewed by the supervising 
multidisciplinary team and changes in the Activity Plans will be made as indicated. Activity Plan Intake 
Assessment:  The Activity Coordinator (at the Alzheimer’s Association) will perform a short virtual intake to 
gather additional information about the PWD to inform the Activity Plan. The Activity Coordinator will collect 
information about activity interests/preferences, executive functioning (e.g., Assessment of Executive 
Functioning TAP, TAP Linking Matrix Screening Questions, Assessment of Physical function, Observation of 
Comportment). These data will be used to develop a weekly activity plan.  Activities: A wide range of activity 
types (over 150) including), exercise/physical (e.g. chair dancing/exercise), cognitive (e.g., virtual brain games, 
educational programming),  music/entertainment (e.g. listening preferred music, singing), social/family (e.g. 
calling or skyping friends, live group book club/poetry reading), manipulation/sensory/sorting (e.g. twiddlemuffs, 
cards), arts and crafts (e.g. painting, coloring, domestic and homemaking (e.g. preparation of snack/light meal, 
folding laundry, doing dishes) are available for selection for incorporation into Activity Plans based on individual 
characteristics cognition, function, and preferences, using previously described guidelines and the TAP 
protocol.81. The volunteer will have use of an approved device (e.g., Samsung Galaxy Chromebook), using 
cellular networks, to support implementation of the planned activities (e.g. to access music, YouTube (or 
similar), and other web-based resources). Training, supervision, engagement: Study leaders will lead 
volunteer training, with participation by colleagues from Johns Hopkins, and Alzheimer’s Association, 
representing a range of disciplines (e.g. medicine, nursing, social work).  OTs participating as consultants will 
already have extensive training in TAP using an online program (http://learn.nursing.jhu.edu/face-to-
face/institutes/NewWay-TAP/index.html ), coupled with face-to-face didactic and interactive teaching. This 
comprehensive initial didactic and interactive training for volunteers, will include but not limited to: orientation to 
the research program, the MEMORI Corps team/roles/program structure, dementia overview (overview of 
dementia diagnoses, needs by stage, behavioral symptoms, home safety, treatments), Zoom use, IRB/HIPPA 
compliance, adverse event and emergency reporting protocols, overview of activity plans, home visit policies 
and safety, engagement and rapport, dementia communication techniques, establishing healthy boundaries, 
instruction in use of a paper log to document activities (described below), how to detect and report behavior 
changes, and stress reduction techniques. We will perform formal competency assessments to ensure 
volunteer readiness. Volunteer trained in Cohorts 2-4 will observe at least 2 companion-guided sessions led by 
peer volunteers as part of the training. Once matched, volunteers will receive ongoing, regular supervision and 
oversight from the volunteer coordinator, OTs, and physician co-investigators during the 1-hour weekly 
volunteer team meetings. These meetings have been found to be a key ingredient to increasing volunteer 
engagement and social support in the Experience Corps program and provide an opportunity to discuss 
challenges encountered, and provide additional training, education, and protocol boosters. Continuing 
education modules (15 minutes) will be included regularly in these meetings to provide additional information 
on key topics (setting up the environment for activities, modifying activities, addressing behavior challenges, 
cultural awareness and competency, maintaining professional boundaries). Volunteers will also be able to 
speak with a study clinician as needed to address specific issues or concerns. Several volunteer oriented 
events will also be held to engage volunteers and reduce attrition as done in Baltimore Experience Corps. 
Matching: To the extent possible, PWD and volunteers will be matched to ensure compatibility. Matching 
characteristics considered may be geography, sex, age, occupation, roles, interests, faith, and culture.  
Activity Delivery Tracking: We will provide volunteers with REDCap based survey links to record delivery 
processes (e.g., day/time of visit, persons in home during visit), details about implementation of the Activity 
Plan (e.g., activities started/completed, time spent in each activity), and ratings of impact/engagement of PWD 
and difficulties/challenges experienced by PWD and/or volunteer for each session, consistent with methods 
developed and used in our five previous trials of TAP. Surveys completed by volunteers at each visit will be 
reviewed and monitored by the Volunteer supervisor at the Alzheimer’s Association on a biweekly basis for 
fidelity during the volunteer team meetings and used to analyze delivery process. Fidelity: To ensure internal 
validity, feasibility, and replication potential: (1) volunteers will be trained as described above; (2) the team 
(volunteers, site supervisors, physician) will meet weekly to discuss cases, procedures, troubleshoot problems; 

(3) volunteer’s activity delivery surveys reviewed on a bi-weekly basis to ensure protocol adherence by 
volunteer coordinator, and (4) standardized operational manuals will be reviewed and provided to all team 
members. 
 
Augmented Wait-list Control. PWD/CG dyads randomized to the augmented waitlist control arm will continue 
any services and supports they are using, will receive a free copy of “A Caregiver's Guide to Dementia: Using 
Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom”103) and written 
educational materials on management of CG stress/well-being. Volunteers randomized to waitlist control will 
continue their usual activities (volunteer or other), and will receive additional written educational materials on 
cognitive health (NIA) and exercise and Physical Activity (Go4Life) and referrals to the Baltimore City 
Commission on Aging and Retirement Education for volunteering opportunities. Waitlist dyads will be followed 
at specified intervals by the research team and then offered an opportunity for participation in the intervention 
arm (at 12 weeks for PWD/CG, and at 12 months for volunteers).  
Measures. Outcome measures will be assessed by masked evaluators at T2, T3, T4, and T5. We will evaluate 
implementation protocol adherence through process and fidelity measures logged by volunteers in the activity 
delivery session surveys (REDCap), program acceptability, satisfaction (adapted from TAP and MIND at Home 
surveys), and skill mastery for PWDs, CGs, volunteers, supervisors will be assessed with self-administered 
surveys at T3, T5, or at time of disenrollment (if premature).  We will also measure how CGs used the respite 
time (T3,T5). We will conduct mixed methods (survey/interviews/focus groups) with a subgroup of PWD, CG, 
and volunteers to refine the operation manual and intervention protocol, post-delivery.  
Inclusion and Exclusion criteria 
PWD/CG must both meet eligibility criteria. These criteria are designed to reduce PWD/CG attrition 
and ensure safety of PWD, CG, and volunteers.  
PWD are eligible if: (1) English speaking; (2) have an established physician clinical diagnosis of 
dementia (any stage) and confirmed with IQCODE cut off >=52 , (3) are able to participate in at least 4 
basic Activities of Daily Living (out of 11), (4) have not received formal (i.e., in-home companion care, 
or adult day center) activity-focused care services in the past 4 weeks, (5) living at home in all counties 
in Maryland and Baltimore City, (6) have a co-residing informal caregiver willing to participate as study 
partner, and (7) 30 years old or older. 
PWD are excluded if: (1) they are deemed to be in a crisis/unsafe situation at baseline, (2) planned 
transition from home in less than 6 months, (3) at end-stage disease (e.g. bed-bound and non-
communicative, or hospice),  (5) they are currently enrolled in a dementia related clinical trial, or (6) 
deemed to have severe behavioral symptoms so severe that they make participation in this study 
unsafe (e.g., are placing self or others at harm). 
CG are eligible if: (1) English speaking, (2) 21 years of age or older (male or female), (3) they are 
deemed to be a reliable informal caregiver (not paid for their caregiving of PWD) who knows the PWD 
well, (4) they are co-residing with the PWD, and (5) are relied on by the PWD for assistance in 
activities of daily living (instrumental or basic).  
CGs are excluded if: (1) they do not plan to be co-residing with the PWD in the next 6 months, or (2) 
they are currently involved in a behavioral/educational clinical trial. These criteria are designed to 
reduce PWD/CG attrition and ensure safety of PWD, CG, and volunteers.  
Volunteers (i.e. “Companion Guides”) are eligible if: (1) English-speaking,(2) 55 years or older, (3) 
High School diploma or GED (minimum) (2) ability pass a basic adult literacy screen (3) ability to pass 
a background check, physical and mental health screening,  (3) a MoCA-Blind score of 18 or above, 
(4) ability to commit to 12 months of service (5 hours per week, excluding travel time and continuing 
education and support), and (5) are reliable during intake and onboarding process and able to 
successfully complete training. 

Volunteers are excluded: (1) if they are planning on moving from the area in the next 12 months, (2) 
unable to provide informed consent, and (3) report having an existing cognitive disorder diagnosis by a 
health provider (e.g., Mild Cognitive Impairment, Alzheimer’s disease or other type of dementia). 
Study Statistics 
Primary outcome variable. 
Aim 2: Preliminary efficacy on PWD quality of life (QOL) and neuropsychiatric symptoms and 
caregiver subjective and objective burden and depressive symptoms compared to augmented wait-
list control over 12 week intervention. We will fit a longitudinal linear mixed effects model with a 
random intercept such that E[Yij]=β0+β1weeks + β2weeks*treatment, and β2 represents the 
difference in change in outcome over time between intervention and wait-list PWD/caregivers 
Secondary outcome variables. 
Aim 2: Preliminary efficacy on volunteer physical function, cognition, and social and psychological 
engagement over 12 months of service.  We will fit a longitudinal linear mixed effects model with a 
random intercept, analogous to those used for PWD outcomes but with months as the unit of time, 
and volunteers as the unit of measure, rather than PWD/caregiver dyad.  Aim 3: Acceptability and 
feasibility of implementing the MEMORI Corps program from various stakeholder perspectives 
(PWD, informal CGs, senior volunteers, volunteer coordinators/supervisors). Analyses for this aim 
will be descriptive, and will evaluate treatment adherence, delivery, fidelity and program 
acceptability and satisfaction from the point of view of the PWDs, caregivers, volunteers, and 
volunteer supervisors.   Exploratory/Secondary Analyses: Additionally, we will model change in 
dyads and volunteers randomized to augmented waitlist followed by intervention, to determine if 
trajectories for outcomes change between the augmented waitlist and intervention periods.  We will 
also combine the intervention period from both study arms and compare baseline and 12-week 
measures (for PWD/CG) or 6- and 12-month measures (for Volunteers).  With regard to PWD 
outcomes, we will model all-cause transition from home (including death) during the first 12 weeks 
as a function of treatment assignment, and we will also compare social engagement and utilization 
of health (ED/inpatient/outpatient, etc.) and community services between the waitlist and 
intervention groups, and measure change in utilization among the waitlist participants after they 
receive the intervention.  We will examine potential predictors of intervention response including 
biological variables such as PWD, CG and volunteer sex, dementia severity, CG relationship,  by 
including intervention x time x predictor terms in longitudinal regression models.  To explore the 
relationships between change in PWDs and caregivers, we will fit parallel process models to data 
from the intervention period.106 For example, such a model would allow for the joint modeling of 
both PWD and caregiver QOL, and would allow for the explicit modeling of correlation between the 
two trajectories.   
Statistical plan including sample size justification  
Analytic Plan. Descriptive analyses will be conducted and measures checked for outliers and to 
ensure that distributional assumptions of the planned analyses are appropriate.  If not, analogous 
non-parametric methods will be used. The outcomes will be primary modeled using mixed effects 
regression models which, unlike the method of generalized estimating equations (GEE), do not 
require data to be missing completely at random.104 These models allow for correlation of outcomes 
over time within individuals.  Clustering at the volunteer level is possible, but since such clusters 
would be small relative to the total sample size, it is unlikely that such clustering would affect 
estimation of standard errors or statistical power to detect a treatment effect.105  All primary 
analyses will be intent-to-treat, and will be adjusted for the variables used to balance 
randomization.  We will use "per protocol" secondary analyses to estimate the efficacy on outcomes 
for intervention participants who receive a minimum dose of intervention (defined as at least 5 hours 
per week for at least 6 weeks or least 30 hours total of companion guided activity programming post 
randomization) compared to usual care group participants (control group) who remain in the study 
for at least 12 weeks post randomization. The intention-to-treat analyses will be the primary analytic 
approach for this trial.   To investigate sensitivity to missing values, those with and without missing 

values will be compared by background covariates.  Tests will be two-sided and p-values <0.05 will 
be considered significant. Multiple test corrections will be applied as appropriate.   
Sample Size Calculations. Using published recommendations for estimation of pilot trial sample 
size targets, we revised the pilot trial sample size (Aim 2) to a sample size of 30 per arm for 
persons living with dementia and caregiver dyads (60 total, including a 20% attrition rate) to plan for 
the future main efficacy trial with 90% power, 2-sided 5% significance and small (0.2) standardized 
effect sizes on continuous outcomes.   For volunteer companion guides, we revised the pilot trial 
sample size (Aim 2) to a sample size of 18 per arm (36 total, including a 20% attrition rate) to plan 
for the future main efficacy trial with 90% power, 2-sided 5% significance and medium (0.5) 
standardized effect sizes on continuous outcomes.