The Getting Active Project (GAP): A Randomized Trial of Volunteering to Reduce Loneliness in Later Life
Phase: NA
Conditions: Loneliness, Quality of Life
Sponsor: University of Rochester

The Getting Active Project/HOPE Project (R01AG054457) 
 
NCT03343483 
 
Study Protocol 
 
4/4/2019 
 
Study Protocol Addendum 
 
2/9/2022 
 
 

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HELPING OLDER PEOPLE ENGAGE (HOPE):
A Randomized Trial of Volunteering to Reduce Loneliness in Later Life
Study Protocol for R01AG054457
Principal Investigator: Kim Van Orden, PhD
Co-Investigators: Ben Chapman, PhD; Yeates Conwell, MD; Silvia Sörensen, PhD; Geoffrey Williams, MD,PhD
Sub-investigators: April Buttaccio, MPH; Laurel Prothero, BS
I. RATIONALE FOR THE STUDY AND SPECIFIC AIMS
Purpose: With the long-term goal of improving quality of life and health in later life, the purpose of this study is 
to examine whether a social volunteering program reduces loneliness and improves quality of life among lonely 
older adults (age 60 and older).
Background: Older adults who are lonely carry increased risk for reduced quality of life,1 morbidity,2-16 and 
mortality.2,7,8,17,18 The risk of premature mortality related to loneliness is at least as large as the risks arising 
from such factors as obesity, physical inactivity, alcohol misuse, and smoking.17 Volunteering is a promising 
intervention for reducing loneliness, in part because it is associated with improvements in three correlates of 
loneliness—perceptions of usefulness,19 social engagement,20-22 and social support.23-26 These three 
constructs may function as mechanisms whereby volunteering reduces loneliness in later life. Although 
volunteering has numerous documented health benefits for older adults, it has never been examined as an 
intervention to improve social well-being. The Helping Older People Engage (HOPE) project will address this 
limitation of the literature.  
Overview of the Design: We propose to compare the effect of a Senior Corps volunteering intervention 
versus self-guided life review control on loneliness in older adults. We will randomly assign lonely older adults 
(150 women, 150 men) to 12 months of either: a flexible social volunteering program, or an active control 
intervention with a self-guided program of life review. Life review is a reasonable active control because it is 
intellectually stimulating (also true of volunteering) but its social component is negligible (unlike volunteering). 
Subjects will be aged 60 and older and have sufficient cognitive and physical capacity to function as 
volunteers, consistent with Senior Corps requirements. 
Specific Aims & Hypotheses: 
Aim 1: To examine the effect of volunteering on loneliness and quality of life.
H1: Older adults randomized to volunteering (vs. control) will report lower loneliness (H1a; UCLA Loneliness 
Scale)27 and greater quality of life (H1b; WHOQOL Scale)28 at 3, 6, 9, and 12 months.
Aim 2: To examine increased social engagement, perceived usefulness, and perceived social support as 
mechanisms for reducing loneliness.
H2: Older adults randomized to volunteering (vs. control) will report greater social engagement (H2a), 
perceived usefulness (H2b), and perceived social support (H2c) at 6 months, which will account for the effects 
on reduced loneliness at 12 months.
Aim 3: To examine conditions under which volunteering is most effective at reducing loneliness.
H3: The effect of volunteering vs. control on loneliness will increase with greater quantity (H3a; hours per 
month) and satisfaction (H3b).
H4 (exploratory): Given that functional impairment impacts all proposed mechanisms, the effect of 
volunteering vs. control on loneliness will be strongest for those with less functional impairment at baseline.
IMPACT: National infrastructure for volunteering programs for older adults—The Senior Corps—ensures that 
volunteering is highly scalable. Dissemination and scaling up efforts will involve connecting primary care 
patients and aging services clients who are lonely with The Senior Corps, which we have shown to be feasible 
in our companion study, The Senior Connection.  Existing infrastructure will make it possible to engage a large 
proportion of lonely older adults in volunteering, thereby reducing loneliness, improving well-being, and 
promoting health.

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II. CHARACTERISTICS OF THE RESEARCH POPULATION
a) Number of Subjects: The study will recruit and enroll 330 subjects into the study using the procedures 
described below. The target number of randomized subjects is n=150 in each group; in our experience 
recruiting for similar studies, thus far, 10% of those enrolled are either not eligible or not willing to be 
randomized, thus we must enroll up to 330 subjects to reach our target number of randomized subjects. 
After providing informed consent and completing a baseline assessment, subjects will be randomized to 
receive either the volunteering intervention (n=approximately 150), or the control life review intervention 
(n= approximately 150.) Subjects will be community dwelling older adults (age 60 or older) and will be 
recruited from primary care practices enrolled in the Greater Rochester Practice-Based Research 
Network (GR-PBRN). Recruitment will also be conducted via in-person in PCP offices and direct 
referral as well as through advertisements, flyers, informational sessions and referrals from the HARP 
database study (RSRB 67245).
b) Gender, Age, Racial, and Ethnic Origin of Subjects: The GR-PBRN serves approximately 30% of 
adults in Monroe County and is generally representative of the population of Monroe County. Although 
we propose to recruit subjects from within the Greater Rochester Practice-Based Research Network (as 
well as outside sources if needed), we anticipate that our study will include subjects representative of 
the current Greater Rochester Practice-Based Research Network (GR-PBRN) client mix. That 
distribution is provided in the Targeted/Planned Enrollment Table below. We intend to purposefully 
select practices, rather than approach them in a random order, so that we can assure the sample is 
generally representative of the race/ethnicity of the entire network (i.e., 78% White, 14% African 
American, 3% Hispanic). We plan to enroll an equal number of men and women. All subjects will be 60 
years or older. 
c) Inclusion Criteria: age ≥ 60 yrs; English speaking; endorse clinically significant loneliness, as 
measured by a score of 6 or greater on the 3-item UCLA Loneliness Scale during an initial phone 
screen; a score of 2 errors or fewer on the 6-item screener (a brief cognitive functioning scale) in the 
initial phone screen; ability to supply their own transportation (or have alternate transportation services, 
including the city bus or services such as Liftline), which are Senior Corps and Lifespan requirements 
for participation. Subjects will have sufficient cognitive functioning to provide informed consent and to 
understand the study requirements and procedures (additional details below).
d) Exclusion Criteria: presentation at screening and the baseline interview with any of the following: 
currently volunteering through Lifespan’s Retired & Senior Volunteer Program (RSVP), current problem 
drinking, psychosis, significant cognitive impairment (MOCA<22), illiteracy, felony conviction (via self-
Racial Categories
Ethnic Categories
Not Hispanic or Latino
Hispanic or Latino
Unknown/Not Reported Ethnicity
Total
Female 
Male
Unknown/  
Not 
Reported
Female 
Male
Unknown/  
Not 
Reported
Female 
Male
Unknown/  
Not 
Reported
American
Indian/  Alaska
Native
0 
0 
0 
0 
0 
Asian 
2 
1 
0 
0 
3 
Native Hawaiian or  
Other Pacific
Islander 
0 
0 
0 
0 
0 
Black or
African
American 
23 
9 
2 
1 
35 
White
135 
154 
2 
0 
291 
More than One Race
1 
0 
0 
0 
1 
Unknown or
Not Reported
Total
161 
164 
4 
1 
330 

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report, as this a requirement of Lifespan, which runs the volunteering intervention), and hearing or other 
problems that preclude engagement as a volunteer.
Other inclusion/exclusion considerations are as follows: 1) We will restrict subjects to those who can 
speak English because the agency that offers the volunteer program (Lifespan) cannot accommodate 
non-English speaking volunteers at this time due to training and supervision needs; 2) given that our 
active control condition involves reading and writing, illiteracy is an exclusion criterion; 3) subjects will 
not be required to cease on-going volunteer activities (for ethical reasons). Subjects will be asked to 
refrain from initiating new long-term volunteer activities during their 12 months of involvement with the 
study (one-time only activities are allowed as these are unlikely to foster social connections). We 
believe this constraint is ethically sound because subjects are permitted to continue current volunteer 
roles and combined with the fact that abstaining from new volunteering will not expose subjects to risk.  
Further, subjects assigned to control will be told they will be connected with our community’s Senior 
Corps program at the end of their study involvement if they choose. Throughout the study, we will 
assess for “dose” of both study and out-of-study volunteer and informal caregiving activities, and co-
vary for this factor in the unlikely event that differences emerge across conditions.
e) Vulnerable Subjects: Individuals who are 60 years of age and older with social risk factors for poor 
mental and physical health outcomes will be included. The results of this study will inform future 
research and clinical interventions aimed and improving mental health treatment for older adults.
III. METHODS AND PROCEDURES
a) Design: The design is a randomized controlled trial. Community dwelling older adults (n=300) will be 
randomly assigned to either the volunteering condition (volunteering) or self-guided life review condition 
(life-review). Those subjects assigned to volunteering will volunteer through Senior Corps by 
participating in social volunteer assignments offered by RSVP as part of their standard process for 
placing volunteers. Those subjects assigned to life review will complete a series of self-guided (with 
minimal email support) life review writing experiences over 12 months. All subjects will receive repeated 
assessments over the course of the study (baseline, 3, 6, 9, 12 months). The 3 and 9 month 
assessments will be online/mail at home or in-person.
b) Intervention Setting: Those randomly assigned to the volunteering condition will receive the 
intervention at Lifespan as well as Lifespan volunteer placements in the community per standard RSVP 
policy and procedures. Those randomly assigned to the life review condition will receive the 
intervention via the phone (for training) and their homes via email/mail.
c) Recruitment Setting: Subjects will be recruited from the Greater Rochester Practice Based Research 
Network.  The GR-PBRN is a network of primary care practices coordinated by the University of 
Rochester’s Clinical Translational Science Institute to provide access to subjects and community-based 
practices for research. The 31 family medicine and internal medicine practices that constitute the 
network care for approximately 217,000 patients, of which approximately 50,000 are over age 60 and 
therefore eligible for initial screening for the study. 
Having received prior approval for the study from the GR-PBRN executive committee (see attached 
Letter of Support), we will approach individual practices for their permission to contact patients on their 
rolls who are ages 60 years and over. These recruitment procedures were used successfully for 
our prior studies—Social Connections and Healthy Aging (The Senior Connection) and Aging 
Well and Social Connections (Engage). We intend to purposefully select practices, rather than 
approaching them in a random order, so that we can assure the sample is generally representative of 
the race/ethnicity of the entire network (i.e., 78% White, 14% African American, 3% Hispanic.) Practices 
will be added sequentially until sufficient subjects have been recruited into the study. 

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In addition, flyers, brochures, advertisements, Facebook and attendance at health fairs and information 
sessions will be used to recruit subjects from the community. We will also be recruiting through referrals 
from the HARP database study (RSRB 67245). 
d) Recruitment Procedures: 
o
Stage 1 - Recruitment
o
Strategy 1 - Informational letters: 

1.A. After obtaining approval from a given practice, the study coordinator will perform a 
(secure) data request for patient names, addresses, and phone numbers for those over age 
60 in that practice. The data request will occur via the URMC CTSI Research Data Request 
procedures and will only involve patients within the covered entity. The research coordinator 
will review and clean the data on a secure device with enforced password protection. He or 
she will then give a designee from the practice the opportunity to review the list and exclude 
patients as needed. These letters, prepared by University Mail Services, will describe the 
study, indicate that the letter is sent on behalf of the research team, and invite those who may 
be interested to call research staff. These letters will state that participation in the study is 
entirely voluntary, and that participation or non-participation will not influence one’s medical 
care. Letters may be sent to the same practices again after at least a year. Patients’ interests 
and eligibility may change after a period of time as well as new patients may now be included.  
Interested patients will contact the research staff and Stage 2 Phone Screening will be 
completed (see below).

1.B. The study coordinator will perform a (secure) data request for patient names, addresses, 
and phone numbers for those over age 60. The data request will occur via the URMC CTSI 
Research Data Request procedures and will only involve patients within the covered entity. 
The research coordinator will review and clean the data on a secure device with enforced 
password protection. These letters, prepared by University Mail Services, will introduce the 
study including a brochure.  The letter will indicate it is sent by the PI, and invite those who 
may be interested to call research staff. These letters will state that participation in the study is 
entirely voluntary, and that participation or non-participation will not influence one’s medical 
care. Letters may be sent again after at least a year. Patients’ interests and eligibility may 
change after a period of time as well as new patients may now be included.  Interested 
patients will contact the research staff and Stage 2 Phone Screening will be completed (see 
below).

Strategy 2 - Flyers and advertisements: Approved flyers and advertisements will be used to recruit 
interested individuals.  The flyers and advertisements invite interested individuals to call or e-mail the 
research staff. Individuals will contact the research staff and Stage 2 Phone Screening will be completed 
(see below). Advertisements will be used in a variety of places, including newspapers, community 
periodicals and magazines.  Lifespan will also post the advertisement on their Facebook page.

Strategy 3 - HARP database study (RSRB 67245): Those who are eligible and interested will be given a 
brochure regarding the HOPE project.  They will be told research staff will contact them.  The contact 
information will be given to the coordinator. The coordinator will contact interested individuals and complete 
Stage 2 Phone Screening. 

Strategy 4 : Primary care office recruitment: 
o
A study staff member, identified by their UR name tag, will introduce him or herself to older adults in 
the waiting rooms of participating primary care practices, show them the study brochure and 
questionnaire, and ask if they have an appointment that day. For individuals who respond that they do 
indeed have an appointment, the study staff member will explain that we are approaching everyone 
who is 60 or older (and who has an appointment) with an opportunity to hear more about a study. The 

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staff member will say that "the office is cooperating with the study and your doctor has asked us to 
hand this information out about it directly to their patients who may qualify." The brochure will briefly 
explain the study.  With assurances that participation is voluntary, it will include a brief questionnaire 
with initial screening questions, with instructions that if the subject is interested in completing the 
survey, he/she should approach the study personnel seating in the waiting room with a sign denoting, 
“HOPE Project.” Due to time constraints, the questionnaire does not contain all screening questions 
for the study.  
o
Individuals interested in participating will then be taken to a private part of the waiting room and 
provided with a brief description of the study, encouraged to ask questions, reminded that 
participation is voluntary, and asked to complete the form. We will ask them to only complete the 
survey once. The questionnaire will be completed with research staff in a quiet, private area of the 
waiting room. Those who screen positive to the screening questions (meet initial inclusion criteria), 
and who give verbal permission to have research staff call them with additional information about the 
study will then be invited to provide their name and contact information. They will be told that study 
personnel may contact them to provide additional information about the study and conduct the 
remaining screening questions to assess eligibility. Due to time constraints, we are not planning to 
assess all screening questions in-office. Participants will provide verbal permission for the telephone 
contact (see “in office script” for exact wording) and also verbally acknowledge that by providing their 
contact information they agree to be contacted by phone by study personnel. No name or other 
contact information is gathered until the patient is determined to meet initial inclusion criteria and to 
be willing to be called with additional information. These patients will then be provided with a brief 
brochure that explains the name of the study and relevant names of key study personnel who will be 
contacting them. Research staff will contact the interested individuals and conduct the remaining 
screening questions.     
o
Participants who do not screen as positive on the initial inclusion criteria questions on the screening 
form will be thanked for their interest. No name or contact information will be collected for these 
individuals. 
Strategy 5: Direct referral
o
Care managers and physicians at participating practices will have the option of telling subjects about 
the project by handing out the approved informational letter and suggesting patients call the study 
coordinator to learn more about the project. 
o
The principal investigator has refined this recruitment method based on her experience with similar 
studies. Recruitment will involve identification of potential patients (of physicians who have agreed to 
participate) through coordination with the practice scheduler or the program i2b2; potential patients 
will be patients 60 or older without diagnoses of dementia, and scheduled within the next week to see 
his/her PCP. The scheduler will share dates, times, and locations for appointments that meet 
eligibility criteria; researchers will not have access to names of potentially eligible patients. Research 
staff will share with the physician the appointment times for which potentially eligible patients are 
being seen; the physician will thus be prompted to share information about the study with potentially 
eligible patients. The physician will emphasize to the patient that research staff are not aware of the 
patient’s name and if they decline to learn more about the study, their information will not be released 
to researchers. If the patient is interested in learning more about the study and gives permission, 
study staff will join the physician at the end of the visit to share information about the study and 
conduct the initial screening (if the patient is willing). Due to time constraints, the questionnaire does 
not contain all screening questions. Research staff will only join the visit if the physician indicates the 
patient has agreed to this.  Those who screen positive to the screening questions (meet initial 
inclusion criteria), and who give verbal permission to have research staff call them with additional 
information about the study will then be invited to provide their name and contact information. They 
will be told that study personnel may contact them to provide additional information about the study 
and conduct additional screening questions to assess eligibility. Participants will provide verbal 
permission for the telephone contact and also verbally acknowledge that by providing their contact 

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information they agree to be contacted by phone by study personnel. Research staff will contact the 
interested individuals and conduct the remaining screening questions.
o
Participants who do not screen as positive on the initial inclusion criteria questions on the screening 
form will be thanked for their interest. No name or contact information will be collected for these 
individuals. 
Strategy 6: Health Fairs
o
Study Staff members will attend local health fairs to provide information and recruit interested 
individuals. Interested individuals will approach study staff members at their table/booth.  
Brochures/bookmarks will be available for individuals to take with them. Study staff will ask if they 
would like to hear more about the study and if so, they will explain the study. If individuals are 
interested and time allows, study staff can ask the screening questions.  If a subject is eligible, the 
staff member can set up a baseline appointment.  If an individual does not have time for the full 
screening, study staff will give interested individuals a brief questionnaire with initial screening 
questions, with instructions that if the person is interested in completing the survey, he/she can 
complete the survey and return it to the staff member.  
o
Those who screen positive to the screening questions (meet initial inclusion criteria), and who give 
verbal permission to have research staff call them with additional information about the study will then 
be invited to provide their name and contact information. They will be told that study personnel may 
contact them to provide additional information about the study and conduct the remaining screening 
questions to assess eligibility. Participants will provide verbal permission for the telephone contact 
(see “in office script” for exact wording) and also verbally acknowledge that by providing their contact 
information they agree to be contacted by phone by study personnel. No name or other contact 
information is gathered until the patient is determined to meet initial inclusion criteria and to be willing 
to be called with additional information. These people will then be provided with a brief brochure that 
explains the name of the study and relevant names of key study personnel who will be contacting 
them. Research staff will contact the interested individuals and conduct the remaining screening 
questions.     
o
Participants who do not screen as positive on the initial inclusion criteria questions on the screening 
form will be thanked for their interest. No name or contact information will be collected for these 
individuals. 
Strategy 7: Informational Sessions
o
A study staff member will provide informational sessions at the medical center or community facilities, 
such as local senior centers/libraries/senior living communities/community organizations/etc that have 
agreed/invited us to speak about our research study. New individuals as well as previously 
screened/eligible individuals will be invited to attend.  The study staff member will give a brief 
presentation about the study to interested individuals.  If individuals are interested and time allows, 
study staff can ask the screening questions (for those not previously screened).  If a subject is 
eligible, the staff member can set up a baseline appointment.  If an individual does not have time for 
the full screening, study staff will give interested individuals a brief questionnaire with initial screening 
questions, with instructions that if the person is interested in completing the survey, he/she can 
complete the survey and return it to the staff member.  
o
Those who screen positive to the screening questions (meet initial inclusion criteria), and who give 
verbal permission to have research staff call them with additional information about the study will then 
be invited to provide their name and contact information. They will be told that study personnel may 
contact them to provide additional information about the study and conduct the remaining screening 
questions to assess eligibility. Participants will provide verbal permission for the telephone contact 
(see “in office script” for exact wording) and also verbally acknowledge that by providing their contact 
information they agree to be contacted by phone by study personnel. No name or other contact 
information is gathered until the patient is determined to meet initial inclusion criteria and to be willing 

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to be called with additional information. These people will then be provided with a brief brochure that 
explains the name of the study and relevant names of key study personnel who will be contacting 
them. Research staff will contact the interested individuals and conduct the remaining screening 
questions.     
o
Participants who do not screen as positive on the initial inclusion criteria questions on the screening 
form will be thanked for their interest. No name or contact information will be collected for these 
individuals. 
Strategy 8: Facebook
o
We will use social media to recruit individuals from Facebook. A community Facebook page for “The 
Hope Lab” will be created to provide potential participants with information about the study and to 
facilitate communication. A screenshot of this page have been submitted along with sample 
unpublished advertisements/posts. Specifically, screenshots of unpublished Facebook 
advertisements have been submitted, and additional advertisements will be created and submitted as 
amendments. We will run 6 ads at a time to recruit participants. The ads will link participants to the 
Facebook page which will provide information about how to participate in research and provides a 
means to update potential participants about informational sessions and previous work the lab has 
done.  We will also post information (date/time/location) regarding any information sessions we will be 
having. Potential participants will be able to send the research team inquiries about the study via 
email and phone, and the account will be monitored weekly. Subjects will be screened as per Phone 
screening below once they contact research staff and are interested. Facebook will only be used as a 
recruitment method. We have disabled posts by other people on the community page timeline, but 
they can contact the page privately. Comments on facebook ads will be monitored daily while they 
are running.
o
Stage 2: Phone Screening
o
Potential subjects will call and speak to research staff or leave a message with their name and phone 
number on the secure URMC voicemail system. When speaking with potential subjects, research 
staff will obtain verbal permission for screening (the script/verbal consent is uploaded in the 
application). During the verbal consent process, research staff will explain the main points of the 
study and ask the older adult if he or she might be interested in the study. If the older adult is 
interested in the study, research staff will obtain verbal consent and then conduct a brief eligibility 
phone screen (including the UCLA 3-item loneliness scale and 6-item screener), answer any 
questions he or she has about the study, and set up a time for the baseline interview (at a URMC 
office). If the older adult is not interested, research staff will thank him/her. Names and contact 
information will not be kept for those who are ineligible or not interested. Those who are ineligible or 
not interested will be informed that they may receive a study letter in the future (not sooner than a 
year) in case interests and eligibility may change.  
o
Stage 3: In-person eligibility and baseline interview: A study coordinator (SC) will conduct the 
baseline interview. First, the SC will explain the study and obtain written, informed consent for the 
subject to participate. The process of obtaining informed consent also involves completing 
procedures to ensure the potential subject has the capacity to provide informed consent (see 
document “Determination of Capacity for Informed Consent). These procedures involve asking the 
potential subject a series of questions to ensure they understand the purpose of the study as well as 
risks and benefits, and the fact that participation is voluntary. These procedures are described in 
detail below in the section on “Informed Consent Procedures” (p. 13). It is at this point in the process 
that the person is considered to be an identified subject in the study (i.e., enrolled). Our exclusionary 
screens will be completed. Next, the SC will explain the need to interview the subject alone (to assure 
unbiased responses). The SC will then administer an additional set of baseline research measures 
that document standard demographic information; social and financial resources; physical health 
(providers, pain assessment, assistive devices), functioning (ADL/IADL ratings), well-being, 

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depression, anxiety, suicide risk, and social connectedness. If during the interview, research staff 
suspects elder abuse or severe neglect, or identifies unsafe living conditions (lack of heat in the 
winter months), the SC will provide the subject with information about care management services and 
the option of the SC making a referral for case management (if consent to release the subject’s name 
and contact information to case management services is provided). The SC will then review next 
steps, including PI review for eligibility, the process of random assignment, and follow-up 
assessments (if eligible). 
o
Randomization: A simple randomization will be used in consultation with the study biostatistician. If 
eligibility can be confirmed by study coordinator at the baseline interview, the study coordinator will 
randomize the subject at that time.  If there are any eligibility concerns, the study coordinator will 
notify the subject that randomization will happen at a later time. The PI will review baseline 
assessment data collected by SC’s weekly to determine eligibility. The SC who conducted the 
baseline interview will call the subject to explain which condition (group) he/she was randomly 
assigned to. The SC will also describe next steps for initiating the intervention, answer any questions 
the subject has, and schedule the next follow-up interview.
o
Intervention/Control: Those in the volunteer condition will meet with Lifespan to initiate the program.  
As per Lifespan requirements, a background check will be completed.  If a subject fails the 
background check, Lifespan will notify the study team.  Lifespan will not disclose the reason(s) why 
the subject did not pass the background check.  They will only indicate that the subject did not pass.  
The study team will contact the subject and inform him/her that he/she cannot participate in the study.  
If a subject passes the background check, the RSVP volunteer coordinator will match the subject with 
a social volunteer activity.  Those in the life review condition will be contacted by a study team 
member to give them information regarding this condition.
o
Follow-up assessments: Subjects will be maintained in the study for 12 months. The initial 
intervention session (i.e., training) will begin within two weeks of randomization. Follow-up research 
assessments will be conducted for both conditions by email or mail at 3 and 9 months (or in-person if 
the subject does not have e-mail access and would prefer to complete them in-person) and in-person 
at 6 and 12 months. An assessment must be completed no later than two weeks after the target 
assessment date. 
e) Assessment Measures & Administration Schedule:
The following tables specify the assessment measures we propose to use in the study:
Screening measures
Measure Name and 
Citation
Construct Measured
Description & Psychometric Data 
Estimated Administration Time
Demographic 
characteristics
Not applicable
Age, gender.
1 minute
3-item UCLA 
Loneliness Short Form
Loneliness
A score of 6 or above has been 
shown to predict mortality. 18,29
1 minute
6-Item Screener
Cognitive functioning
These 6 items ask questions 
measuring orientation and short-
term memory.
1-2 minutes
National Institute on 
Alcohol Abuse and 
Alcoholism (NIAAA) 
single-item test
Alcohol misuse
This single item has greater than 
90% sensitivity and specificity in the 
detection of alcohol use disorder. 
1 minute
Screening and 6 month visit
The CAGE 
Questionnaire30
Alcohol misuse
This 4 item questionnaire will be 
used as an exclusion screen. A 
1 minute

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score of 2 or above is considered 
clinically significant.
Screening and 6 month visit
Self-Assessed Literacy 
Questions
Literacy
2 self-assessed questions regarding 
reading and writing abilities needed 
for the study
1 minute
Descriptive measures, and psychiatric/medical covariates
Measure Name and 
Citation
Construct Measured
Description & Psychometric Data 
Estimated Administration Time
Demographic 
characteristics
Not applicable
Age, race/ethnicity, gender, sexual 
orientation, employment status (and 
history), income, education, living 
situation, marital status, PCP name, 
emergency contact, self-report 
endorsement of felony conviction.
3 – 5 minutes
in-person interviews
Brief Grief 
Questionnaire31
Grief
This brief self-report measure 
assesses social functioning 
impairment associated with 
bereavement.
1 minute
in-person interviews if 
applicable
Zarit Burden 
Inventory—Screening 
Version32
Caregiver burden
This brief measure assesses self-
perceived degree of burden 
associated with providing caregiving.
1 minute
in-person interviews if 
applicable
Medical conditions and 
medications 
Physical health 
This measure is checklist of self-
reported medical conditions derived 
from the Minimum Data Set Version 
2.0. Data on medications will be 
used to create the Composite 
Antidepressant Scale (CAD), a 
measure of antidepressant dosage. 
Questions about adherence to 
medicines will also be asked to 
determine if the prescribed dosage 
is being taken.
5 minutes
in-person interviews
WHO Disability 
Assessment Schedule 
2.0 WHODAS 2.033
Functional 
impairment
Functional impairment will be 
measured by client self-reporting of 
six domains: cognition, mobility, self-
care, social, life activities, and 
participation. In order to adequately 
characterize our sample, we will 
obtain the degree to which subjects 
experience functional impairment. 
10 – 15 minutes
baseline and final interview
Big Five Inventory-
Short Form (15)34 
Personality traits
This very brief self-report measure 
(15 items) assesses the “Big Five” 
personality traits. This measure is 
included because personality may 
moderate (or affect) outcomes.
3-5 minutes
baseline only
PROMIS Depression 
and Anxiety 
Computerized 
Adaptive Tests35
Depression and 
anxiety symptom 
severity
These brief computerized adaptive 
tests has been found to be sensitive 
in detecting clinically significant 
depression and anxiety, as well as 
being sensitive to change.36
3-5 minutes
all time points
Volunteering History 
Interview37
Subjects’ histories of 
volunteering for the 
Developed by The International 
Labour Association.
5 – 15 minutes
In-person interviews

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prior year and past 
month
Montreal Cognitive 
Assessment (MOCA)38
Global cognitive 
functioning
The Montreal Cognitive Assessment 
(MoCA) was designed as a rapid 
screening instrument for mild 
cognitive dysfunction. It assesses 
different cognitive domains: attention 
and concentration, executive 
functions, memory, language, 
visuoconstructional skills, 
conceptual thinking, calculations, 
and orientation. Time to administer 
the MoCA is approximately 10 
minutes. The total possible score is 
30 points; a score of 26 or above is 
considered normal. Nasreddine and 
colleagues report high sensitivity 
and specificity for MOCA scores in 
detecting MCI.38 The MOCA has 
three alternate forms in English to 
prevent practice effects with repeat 
administration, as well as a form for 
blind individuals.
10 – 15 minutes
at baseline and final interview 
(alternate form used at final 
interview)
Columbia Suicide 
Severity Rating Scale 
(CSSRS)39
History of suicidal 
ideation and 
behaviors 
The CSSRS is an interview that 
assesses for worst-point lifetime and 
past month suicidal ideation and 
behavior. It has been shown to 
predict future suicidal behavior39 and 
is the current gold standard for 
assessing suicide risk in clinical 
trials.
5 –15 minutes
In-person interviews 
(time frame is “since last visit” 
for follow-up interviews)
Mood Improvement 
Protocol (MIP)
Self-perceived 
distress (before and 
after interview) and 
coping strategy (i.e., 
mood improvement 
activity)
The research interview may elicit 
negative reactions in individuals who 
are having difficulties in areas of 
their life related to questions in the 
assessment. Thus, this measure, 
adapted from procedures designed 
by Linehan and colleagues, is 
designed to enhance retention and 
improve subjects’ experience in the 
research assessments.
5 – 10 minutes
In-person interviews
Qualitative Feedback
Subject’s experience 
in the research 
program
Open-ended questions to assess the 
subject’s experience throughout the 
research program
5-10 minutes
6 and 12 month interviews
Volunteer Satisfaction 
Survey and Volunteer 
Benefits Survey
Subject’s 
experiences in the 
volunteer program
Feedback to assess the subject’s 
satisfaction and benefits from 
volunteering
5 minutes
Volunteer condition only
6 month and final interview 
Life Review 
Satisfaction Survey
Subject’s 
experiences in the 
life review program
Feedback to assess the subject’s 
satisfaction with life review
2 minutes
Life Review condition only
6 month and final interview
Credibility and 
Expectancy 
Questionnaire (CEQ)
Subject’s expected 
benefits
Questionnaire to assess subject’s 
expected benefits of the program
2 minutes
Baseline and 12 month 
interview

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Sexual Orientation 
Concealment Scale 
(SOCS)
Subject’s 
concealment of 
sexual identity
Questions designed to assess 
lesbian, gay, and bisexual (LGB) 
individual’s active concealment of 
their sexual minority status
2 minutes
Baseline for those who 
answered as LGB on 
demographic form.
6 and 12 months – for those in 
volunteer group who had 
answered as LGB on 
demographic form at baseline.
Randomization 
Feedback
Subject’s experience 
with randomization
Feedback from the subject on the 
randomization process and their 
satisfaction with the group to which 
they were randomized
5 minutes
12 month interview
Social connectedness measures
Measure Name and 
Citation
Construct Measured
Description & Psychometric Data
Estimated Administration 
TIme
Revised UCLA Loneliness 
Scale, version 327
Global loneliness
Yields a continuous score, with 
greater scores indicating greater 
loneliness; it will be used to 
assess loneliness at all 
assessment time points. It has 
demonstrated excellent internal 
consistency, test re-test reliability, 
and construct validity 
(associations with social support 
and social network size),27 
including with older adult 
samples.13,27 Importantly, it has 
been shown to be sensitive to 
change as a result of 
intervention.40
3 - 5 mins
all time points
De Jong Gierveld 
Loneliness Scale41
Social and emotional 
loneliness
It had demonstrated excellent 
psychometric properties and 
construct validity.
3 - 5 mins
all time points
Lubben Social Network 
Scale42
Social network size 
and frequency of 
contact.
This set of self-report questions 
has been shown to predict 
premature mortality.
3 – 5 mins;
all time points
Interpersonal Needs 
Questionnaire (INQ) 43,44
Thwarted 
belongingness (TB), 
perceived 
burdensomeness 
(PB).
Van Orden et al. 43 report high 
internal consistency coefficients 
for the thwarted belongingness 
(=.85) and perceived 
burdensomeness subscales 
(=.89). In support of construct 
validity, both subscales were 
found to positively correlate with 
suicidal ideation.
3 – 5 minutes
all time points
Behavioral Activation Scale 
for Depression (BADS)—
social subscale45
Social activation.
Kanter and colleagues present 
evidence of the scale’s 
psychometric properties, including 
solid factor structure, internal 
consistency, and test-retest 
reliability.
2-4 minutes
in-person interviews
Volunteer Functions 
Inventory46 
Reasons individuals 
participate in volunteer 
activities
Konrath and colleagues 
demonstrated good psychometrics 
3-5 minutes
Volunteer condition only

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and a latent structure consistent 
with several subscales.
6 months and final 
interview 
PROMIS Social 
Functioning Computerized 
Adaptive Tests47
Emotional support, 
informational support, 
instrumental support, 
satisfaction with social 
roles and activities, 
social isolation, 
companionship
These computerized adaptive 
tests measure several domains of 
social functioning.
5 – 7 minutes
In-person interviews
Rosenberg Mattering to 
Others Scale48
Mattering to others (5 
items)
This is the most commonly used 
measure of perceptions of 
mattering and has numerous 
reports of solid psychometrics
2 – 3 minutes
In-person interviews
Quality of Life measures
Measure Name and 
Citation
Construct Measured
Description & Psychometric Data
Estimated Administration 
TIme
WHOQOL-BREF28
Health-related quality 
of life
This brief 36 item measure 
assesses several domains of 
health related functioning and 
quality of life. It has excellent 
psychometric properties and can 
be used cross culturally.
10 - 15 minutes 
baseline and final interview
PROMIS Quality of Life 
scales49
General life 
satisfaction, Meaning 
and Purpose, Positive 
Affect
These measure several domains 
of quality of life. The purpose in 
life items have been empirically 
linked to volunteering in older 
adults.50
4 - 6 mins
in-person interviews
Reminiscence Functions 
Scale51
Measures reasons 
individuals engage in 
reminiscence, which is 
a key component of 
the life review 
intervention.
Robitaille et al. provide support for 
the 8 subscales and data that 
demonstrate adequate 
psychometric properties in a 
sample of older adults. 
6 – 8 minutes
Life review only
6 month and final 
interviews
Brief Measure of 
Generativity and Ego 
Integrity52
Generativity 
(perceptions of giving 
back, especially to 
younger generations) 
and ego integrity 
(looking back on one’s 
life with meaning)
Vuksanovic and colleagues52 
provide data indicating that this 
shortened measure provides 
adequate construct coverage.
2 – 4 minutes
In-person interviews
Attitudes to Ageing 
Questionnaire AAQ
Feelings on getting 
older
This set of self-report questions 
allow subjects to express their 
attitudes towards aging.
5 minutes
In-person interviews
Total estimated time for entire baseline 
interview 
90 – 153 minutes
f)
Study Conditions:
Volunteering condition: HOPE volunteers are supported by Lifespan and the Senior Corps. The Senior 
Corps is one of Lifespan’s many programs for seniors in the community. Its objective is to match seniors with 
volunteer opportunities that match their interests and capabilities. Subjects will begin training at Lifespan within 
two weeks of randomization.  Aging Services agency-supported volunteer placement in a social volunteer 
activity is initiated for one year. The target expectation for volunteering is 4 times per month (about once per 
week). Lifespan collects monthly timesheets, which will include the number of hours and types of volunteer 

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activities done. The Senior Corps provides a small reimbursement for travel to volunteers as needed for travel 
related to volunteering. The other component of the intervention is on-going training (“booster sessions”), 
volunteer support groups, and educational activities offered by Lifespan. These gatherings for volunteers serve 
to promote retention in the program, assist volunteers with any problems/issues that have arisen, and promote 
social connectedness among volunteers. This is standard Lifespan policy. 
Control Condition: The active control group was chosen to control for (and minimize confounding by) 
potential non-specific effects of participating in a study intervention; expectancies about benefit; and starting a 
new cognitively engaging activity. Subjects randomly assigned to the active control group will complete a self-
guided life review exercise over 12 months.53,54 This standardized and evidence based intervention is 
commonly used to reduce depression and promote well-being in later life; further, it was recently tested (and 
validated) as a self-guided intervention to improve well-being by Lamers and colleagues54; life review was also 
used as a control condition for a NIA-funded randomized trial of problem solving therapy for older patients with 
macular degeneration (R01AG032032, Sörensen, PI)53 that was recently completed in the UR Department of 
Psychiatry. Dr. Sörensen will be available to advise the HOPE team regarding implementation of this condition. 
To minimize the social nature of providing the intervention (i.e., minimizing confounding our conditions), the life 
review will be largely self-guided, including replacing the counselor (and one-on-one sessions) with email 
support and a self-help book, per the protocol of Lamers and colleagues.54 Subjects will complete two sections 
of the life review (with the self-help book) each month and send ‘assignments’ twice per month to an email 
‘counselor’ who will respond with supportive comments within three days (per Lamers et al., protocol). The 
minority of subjects who do not have access to email will be provided the opportunity to participate via regular 
mail. The Lamers and colleagues’ intervention was found to enhance psychological well-being. Studies 
examining individual life-review, including Sörenson’s, indicate that life review reliably reduces depressive 
symptoms, but does not reduce loneliness (though group life review may increase social integration).55 Further, 
life review is associated with high compliance rates, comparable to—or exceeding—compliance rates for other 
evidence based interventions for older adults.53,56 These data indicate that life review will represent a face valid 
intervention for subjects, thus increasing expectancies of positive benefit and promoting compliance and 
retention. Our active control condition will provide benefit to subjects without reducing loneliness, thus 
addressing one of the largest confounds for behavioral interventions, especially interventions of an extended 
duration—expectancy effects57,58—while also promoting high compliance rates.  
g) Analytic Procedures:
Power analysis is conducted to test treatment effects by the intent-to-treat (ITT) analysis for the primary 
hypothesis. We assume a conservative 20% attrition rate and a 0.3 within-subject correlation.  A sample size of 
N = 300 (or N = 150 per treatment group) will allow us to detect a small effect size of 0.2 for loneliness, with 
80% power based on a two-sided type I alpha = 0.05.  The assumed within-subject correlation of 0.3 reflects 
the relatively long time lag between consecutive assessments. The proposed sample size also has 80% power 
to detect 32% mediation effects for loneliness, a continuous outcome.  If full mediation is not achieved for any 
of the mediators considered, 32% mediation effects are sufficiently large to be of clinical importance for the 
outcomes of interest.
Descriptive statistics will be computed to summarize distributions of each outcome, with means and standard 
deviations for continuous outcomes and percent for categorical outcomes.  Two-sample t tests (or the Mann-
Whitney-Wilcoxon rank sum test) and Chi-squares will be used to examine balance of treatment randomization 
for continuous (if distributions are highlight skewed) and categorical variables.  The primary hypotheses are 
concerned about the effectiveness of volunteering on reducing loneliness vs. control.  Examination of 
mechanisms (mediation, Aim 2) as well as dose-response relationships (Aim 3) and moderators (Aim 3) of the 
intervention will also be examined. Aim 1 (and Aim 3 H4 on moderation) will be tested using longitudinal 
regression models, while the mediation hypothesis (Aim 2) will be examined by structural equation models, and 
dose-response relationships (Aim 3) by structural mean models.  
The two most popular longitudinal models are the generalized linear mixed-effect models (GLMM) and the 
weighted generalized estimating equations (WGEE). Weighting is based on inverse probability of drop-out, 
extending standard GEE from valid inference only under missing completely at random to missing at random, 
similar to GLMMs. For inference about treatment effects, both models can be applied. However, parametric 

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GLMM requires distribution assumptions, making inference sensitive to departures from assumed distributional 
models.59-61 The semi-parametric WGEE requires no such assumption, thereby providing valid inference for a 
broader class of data distributions. We will use both models; if discrepancy arises between the two, we will 
report the results based on WGEE. Both models address missing data under the missing at random (MAR) 
mechanism.62-64 Biased estimates may still arise if missingness follows the non-ignorable non-response (NINR) 
mechanism. Although quite rare, and we do not anticipate such a missing data mechanism in this study, we will 
examine this issue by performing sensitivity analyses under some non-ignorable missing data models.59,65 
Structural equation models (SEM) will be applied to test the mediation hypothesis involving the putative 
mediators of usefulness and social support.66 Again, the popular maximum likelihood (ML), generalized least 
squares (GLS), and weighted least square (WLS) estimates are all biased under MAR, if parametric 
assumptions are not met by data in the study.67,68 We will also use recent distribution-free methods for more 
robust inference.67 If results differ significantly between the maximum and distribution-free methods, only 
estimates from the latter will be reported.  Common indices for assessing goodness-of-fit include likelihood ratio, 
Akaike (AIC) and Bayesian criteria. For SEM, popular goodness-of-fit measures include chi-square test, the 
comparative fit index (CFI), the index of Tucker and Lewis (TLI), and Root Mean Square Error of Approximation 
(RMSEA).66,69,70
The ITT analysis for Aim 1 provides intervention effects averaged over all subjects randomized to the intervention 
conditions.  When intervention compliance (volunteering hours/satisfaction for subjects in the volunteering 
condition) demonstrates a dose-response relationship, as we hypothesize in Aim 3, complier average causal 
effects (CACE) are appropriate; thus we will use them to test Hypothesis 3. CACE is a compliment to ITT 
analyses and provides an answer to a different question than is answered by ITT analyses (i.e., the result of 
complying vs. being offered an intervention).71 CACE provides valid causal inference because it maintains 
randomization and includes all subjects in the analysis, as with ITT.72 CACE provides different intervention effects 
for individuals depending on their levels of compliance, which can be quite informative, especially when there is 
large variability in intervention compliance and strong dose-response relationships.  The ITT and CACE 
estimates from a similar intervention study by Gruenewald, et al.73 show that not only were the CACE effect 
sizes much larger than their ITT counterparts (small ITT vs. large CACE effect size), but the temporal trend 
also reversed; while the ITT effect sizes decreased, the CACE effect sizes increased from 4 months to 12 
months post intervention, indicating substantial heterogeneity in intervention compliance and strong dose-
response relationships.  Since volunteering time is only required for the volunteering condition, standard 
statistical models cannot be used to perform CACE analysis. The CACE approach enables an estimate of the 
treatment effect at each level of “compliance” (i.e., amount of hours volunteered), without the need for a measure 
of compliance in the control group. In this way, we will be able to tell how well volunteering reduces loneliness at 
different “doses” of volunteering. The two most popular methods for addressing intervention compliance are the 
parametric principal stratification (PS) and the semi-parametric structural mean model (SMM).74-76 Unlike the PS, 
the SMM not only allows for continuous dose variables, but also requires no parametric model for data 
distribution such as normality, thereby yielding robust inference for a broader class of data distributions.  We will 
use the latest SMM based on the structural functional response models (SFRM) for our CACE analysis, which 
not only allow for continuous, but also multiple dose variables. 74-76  We are particularly interested in potential 
non-linear dose-response relationships so that we may determine optimal dose intervention whereby increased 
exposure (i.e., number of hours volunteered) becomes less worthwhile (in terms of reducing loneliness).  
Aim 1 compares subjects randomized to either the volunteering or control on loneliness (continuous variable). 
H1a: There will be a condition effect on loneliness at all time points indicating differing levels of loneliness in 
the direction: control > volunteering. Longitudinal models will be employed with loneliness as the response, 
and condition, time and their interaction as the predictors, controlling for age, gender.  If a significant difference 
exists (a significant time by condition interaction), appropriate linear contrasts will confirm the hypothesized 
directional effects. For H1b, the same analytic strategy will be used, but with quality of life (continuous) as the 
response variable. Aim 2 involves mediation analysis: is to examine perceived usefulness and social support 
as mediators of the intervention effect on loneliness. H2a: Increases in social engagement at 6 months is 
hypothesized to mediate the effect of intervention condition on decreased loneliness at 12 months.  The SEM-
based mediation models will be applied, with social engagement as the mediator, intervention condition as the 
predictor and loneliness as the outcome, controlling for age, gender.  If the null of full mediation is rejected, we 
will estimate direct, indirect and total effects to assess the strength of mediation. The same analytic strategy 

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will be used for perceived usefulness and social support (H2bc). Aim 3 involves when volunteering will provide 
maximal benefit. H3: Greater hours (compliance) and satisfaction will be associated with better outcomes. We 
will apply the SFRM-based SMM to analyze dose-response relationships.  We will first model dose using non-
parametric methods and then characterize the patterns using parametric methods.  This allows us to capture 
detailed dose and response relationships and provide more interpretable findings. H4: The longitudinal model 
for H1a will be used with functional status as a moderator variable.
h) Data and Safety Monitoring Plan: 
(i)
Overview: The purpose of the Data and Safety Monitoring Plan (DSMP) is to specify the 
procedures and rationales of the current study to ensure the safety of participants and the validity and integrity 
of the data. This specifies who will look at the data and review any adverse events, how often, and what they 
are authorized to do. The use of Data and Safety Monitoring Boards (DSMBs) may be indicated if the studies 
have multiple clinical sites, are blinded (masked), and/or employ particularly high-risk interventions or 
vulnerable populations. This study on the other hand will be conducted utilizing a low risk intervention in a 
population of older adults residing independently in the community. Therefore, we have chosen to include a 
modified DSMB that, while constituted by individuals connected to the study, will systematize monitoring safety 
issues throughout its duration.
(ii)
DSMB Membership: Dr. Jeffrey Lyness will chair the DSMB. Dr. Lyness is Professor of 
Psychiatry at URMC and an expert in research and clinical care of older adults. Other members will include 
Kimberly Van Orden, Ph.D., Yeates Conwell, M.D., and Deborah King, PhD. Dr. Van Orden is the principal 
investigator of the project and Dr. Conwell is a Co-Investigator and geriatric psychiatrist. Deborah King is the 
outside member of the DSMB and is a clinical geropsychologist.
(iii)
DSMB Responsibilities and Actions: The DSMB will maintain an overview of the quality of 
the accumulating data and provide guidance to the PI on interim analyses and stopping rules. The DSMB will 
also serve as liaison among study investigators and the University of Rochester Medical Center Research 
Subjects Review Board (RSRB) and the NIH. It will review and approve, disapprove, or suggest modifications 
to the study protocol and/or consent documents to assure both scientific integrity and that studies adhere to 
human subject protection policies. It will monitor, provide feedback, and report on scientific and ethical issues 
related to study implementation for the protection of human subjects and advise on ethical issues related to 
adverse events. The DSMB will monitor adverse event reports for purposes of determining whether their 
nature, frequency and severity are consistent with expectations. It will report to the RSRB and NIH any 
unanticipated problems involving risks to subjects (per 45CFR46). If considered related to the study, 
unanticipated adverse events involving risks to subjects or to others must be reported by the P.I. and/or DSMB 
to the RSRB. The RSRB will promptly inform NIH. Along with the RSRB and NIH staff, the DSMB can 
recommend remedies or other appropriate actions such as introducing new monitoring protocols, altering 
inclusion or exclusion criteria, or recommending changes in the informed consent documents.  
As well, the DSMB will be charged with ensuring that the study protocol maintains subjects’ confidentiality in a 
manner that is appropriately balanced with issues of clinical care and safety, where relevant, and will monitor 
data management activities. The DSMB will review requests for interim analyses and approve, disapprove, 
require additional information, or defer decisions.
The DSMB will be kept apprised of all severe adverse events on an ongoing basis and will serve as the final 
arbiters of whether individual subjects should be removed from the protocol. The DSMB will be called upon 
whenever possible to render judgments in the advent of a severe adverse event. We acknowledge that there 
may be rare instances where some emergent situation occurs that was unanticipated regarding the welfare of 
the subject. In these situations, the University of Rochester Medical Center's RSRB or the DSMB may be 
contacted to help resolve the situation.
(iv)
Meeting Schedule: At a minimum, the DSMB will convene on an annual basis. DSMB 
conferences will be assembled in-person, and conducted in accordance with federal and state health privacy 

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legislation and relevant standards. The Chair and the P.I. will determine meeting logistics based upon urgency 
and the availability of DSMB members. 
(v)
Adverse Events (AEs) and Serious Adverse Events (SAEs). 
We will abide by the rules governing reporting of adverse events as defined in NIH Policy on Data and Safety 
Monitoring in Clinical Trials (September 2002, revised 2007). Any event will be reported to the RSRB if it is 
“serious,” “unexpected,” and “related.”
Reportable Events: Definition of terms

“Serious” means any event that causes a prolonged or permanent harm that is psychological, social, 
legal or financial. Examples most pertinent to this study include a subject’s death from any cause; a 
suicide attempt or hospitalization due to depression.

“Unexpected” means that the event was unforeseen and has not been previously encountered, known, 
or recognized and was not identified in nature, severity, or degree of incidence in the protocol, 
supporting documentation, the informed consent document, or the RSRB application.

“Related to the study” means that there is some aspect of the study (e.g., a research procedure, 
existence of a laptop database, etc.) that is directly related to the event. An example pertinent to this 
study is breach of confidentiality by which private information about the subject was made known to 
other community members. Events for which the relationship to the study cannot be clearly determined 
based on review of all available data will be classified as “possibly related to the study” and reported 
according to the same guidelines as for related events.

“Event” is an incident, experience, or outcome that occurs to a subject participating in an RSRB-
approved research study.
The following rules describe the procedures for adverse events that will guide us:

AEs are reported to the sponsor, regardless of whether they are considered study related. They 
may include hospitalization or death.

The date and time of onset and outcome, course, intensity, action taken, and causality to study 
treatment will be assessed.

The Principal Investigator has the final decision regarding what is to be reported on the adverse 
event form, and has the option to reclassify an AE as a serious adverse event (SAE). In general, 
a serious adverse event (SAE) is an event where a relationship to the research study cannot be 
ruled out and the event is life threatening/results in death OR disabling/incapacitating OR 
requires or prolongs hospitalization OR involves an overdose OR was otherwise unanticipated, 
related to the study procedures or could lead to one of the other serious event conditions.

In case of an SAE: The date and time of onset and outcome, course, intensity, action taken, and 
relationship to study treatment will be assessed. SAEs will be reported to the CDC, DSMB, and 
the RSRB within 24 hours. A written report will be forwarded to NIH, DSMB and the RSRB 
within 5 working days of the investigator's discovery of the event. 
i)
Data Storage & Confidentiality: 
Electronic data will be collected in a password protected, secure web-based application called REDCap 
(Research Electronic Data Capture). This web-based data entry system replaces the current process of 
collecting data on paper copies and entering the data afterwards via a system residing on a local 
computer.  The electronic data capture system provides a secure, HIPAA-compliant web-based 
application that is flexible enough to be used for a variety of types of research, provides an intuitive 
interface for users to enter data and has real time validation rules (with automated data type and range 
checks) at the time of entry.
REDCap servers are housed in a local data center at the University of Rochester and all web-based 
information transmission is encrypted.  REDCap was developed in a manner consistent with HIPAA 
security requirements and is recommended to University of Rochester researchers by the URMC 

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Research Privacy Officer and Office for Human Subject Protection. A laptop or iPads will be used to 
collect the encrypted data on REDCap.  
No protected health information will be stored on portable media, including laptop computers or 
removable hard drives.  The data (including names and all identifiable information) will be encrypted 
using SSL.  Only authorized study personnel and regulatory personnel (e.g. auditors) will be allowed 
access to data.  All access to the database will be controlled by passwords with varying levels of 
security and access.  The iPads or laptop will be used by the coordinator and subject.
Users will be assigned access to the application by personnel in the Department of Biostatistics and/or 
study personnel.   REDCap also tracks who enters the data.  No data are stored on the iPad or laptop 
devices. 
In addition, all applications, projects, and user accounts are stored on mirrored disks. If one disk should 
fail, the remaining disk of the mirror is used, and no data loss or downtime is experienced. Weekly, a 
backup is removed from the site and stored in a secure location. Only specific users are allowed access 
to projects; the system administrator specifies these users.  Watcher programs are used to keep a 
close eye on disk utilization, rogue, user and daemon processes, as well as rogue system alterations.  
These programs help to tune the system for maximum performance and help maintain the reliability of 
the system.  Security monitoring programs are used to alert us to possible security holes, which may be 
exploited by would-be crackers. The University of Rochester Medical Center also maintains a firewall in 
front of their Enterprise network, providing an additional level of security.
In order to protect the confidentiality of subject information, we will take a number of precautions. These 
include training of research interviewers in confidentiality procedures; entry and storage of data using 
coded identification labels; maintenance of project computers (both PRN and clinical research 
hardware) in secure locations with restricted access by enforced password protection.
IV. RISK BENEFIT ASSESSMENT
1.
Risk Category
Minimal risk.
2.
Potential Risks
a.
For the assessments/questionnaires, the risks are as follows: discovery of depression or suicide 
ideation, invasion of privacy, breach of confidentiality (if safety issues are detected), or mild 
reactions of distress or fatigue. All assessment measures and procedures have been safely used in 
previous research with older adults; no sustained negative effects from assessments are expected, 
but negative outcomes cannot be ruled out. 
b.
The interventions, volunteering and life review, carry the risk of causing emotional distress or 
fatigue. Our volunteers may experience stressors as a result of volunteering.. Our intervention 
includes support for volunteers through these experiences. Subjects assigned to life review may 
write and think about memories of negative experiences; they will receive support for such 
experiences. No sustained negative effects are expected, but negative outcomes from behavioral 
interventions cannot be ruled out. The volunteer coordinator and care manager are experienced in 
working with older adults and in assisting volunteers through situations involving loss. The life 
review supervisor is also experienced in working with older adults and assisting participants through 
the experiences of recalling stressful memories.
c.
Regarding alternative interventions, subjects will not be prohibited from seeking out supportive 
social services, or volunteering their services to others (for ethical reasons), but subjects will be 
asked to refrain from initiating new long-term volunteering experiences during their time in the 
study. If a subject in the volunteering group does engage these services, he/she will be followed for 
the full 12 months, with documentation of the nature and extent of that engagement, and evaluation 
of its impact on the outcomes of interest.

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3.
Protection Against Risks
a.
In order to protect the confidentiality of subject information, we will take a number of precautions. 
These include training research interviewers in confidentiality procedures; entry and storage of data 
using coded identification labels; maintenance of project computers in secure locations with 
restricted access by enforced password protection; use of HIPAA compliant data management 
software (REDCAP). Back-ups of all study files will be made daily to allow for recovery of data due 
to disk failure. Risks associated with subject burden or distress will be minimized by employment of 
research personnel with appropriate backgrounds and experience and work with psychological 
factors and elderly subjects. The baseline research interview will last approximately two and a half 
hours in total. Given the length of time involved for this assessment, and concerns regarding 
subject health and well-being, subjects will be reminded that if they become fatigued, they may 
terminate the interview at any time, and that the interview can be conducted over multiple sessions 
as needed. Research personnel will further be trained to recognize potential signs of fatigue among 
elderly subjects, and to actively suggest alternative data collection strategies (including telephone-
based, internet-based and mail-in interviews), in order to reduce the possibility of overwhelming 
study subjects and to ensure completeness of data collection. These strategies have been 
employed effectively in Drs. Van Orden and Conwell’s past research involving older adult 
populations.  All data, including assessment measures, will be obtained with the written consent of 
the patient. Information pertaining to individual participants will be released with the patient's 
informed and written consent only, except in unusual cases where withholding the information might 
pose a serious risk or danger to the participant or others. All data will be identified by a uniquely 
coded study number assigned to each participant. Access to the master list of study numbers will 
be restricted to Dr. Van Orden and the CRC. Confidentiality will be further maintained by the 
storage of "hard copy" data in locked files in a locked office. Access to computerized data is 
restricted and subject to review by Dr. Van Orden. Publications or presentations will report only 
cumulative data or descriptions certain to maintain participants' anonymity. All data collection 
involving human subjects will be HIPAA compliant. All data involving human subjects will be 
stripped of any identifiers; the data will be stored in a secure HIPAA compliant program called 
REDCAP, which manages protected health information in a HIPAA compliant manner. Internet 
surveys will be housed in REDCAP and subjects will directly enter their responses into REDCAP.
b.
During the course of assessment interviews, the CRC will monitor subjects' reactions for signs of 
distress or fatigue. If necessary, subjects may take breaks from the interview, or complete the 
interview over several sessions if fatigue becomes a concern. 
c.
We propose to manage potential distress elicited by the research assessment with implementation 
of a “Mood Improvement Protocol” (MIP). The MIP is designed to enhance retention and improve 
subjects’ experience in the research assessments. We propose to include procedures to help such 
subjects manage distress that may arise during the research assessments. Specifically, the MIP 
involves the research assessor (study staff) collaboratively creating a coping plan for managing 
distress with the subject prior to completing the interview. Such coping strategies include: engaging 
in chit chat with study staff, sharing a cup of tea, etc. The protocol also involves having the subject 
rate his/her level of distress at the start of the interview and after the interview. This will allow study 
staff to better manage the risk of distress by providing a gauge of subjects’ change in level of 
distress at the conclusion of the interview. If a subject remains highly distressed after the interview 
(highly unlikely), study staff will engage in a coping activity with the subject and/or call Dr. Van 
Orden. We have successfully used this procedure in prior studies.
d.
If a subject's safety becomes a concern, the researcher will evaluate the subject's emotional state 
and safety. If the subject appears distressed, the CRC will briefly attempt to de-escalate the 
patient's distress. If these measures do not effectively reduce the patient's distress within 10-15 
minutes and depending on the severity of the patient's distress, the CRC will call Dr. Van Orden or 
Dr. Conwell, who will maintain cell phones for this purpose. If neither is available, or if otherwise 
necessary, intervention will be provided by a clinician with Psychiatric Emergency Department.  

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4.
Informed Consent Procedures: A CRC will obtain verbal consent from subjects before beginning the 
phone screening. At the conclusion of the phone screening, the CRC will explain that written informed 
consent will be obtained at the next assessment at an office at the University of Rochester Medical Center. 
The CRC will obtain written consent from subjects before the baseline in-person assessment only after 
subjects have received both verbal and written explanations of the study and indicated their full 
understanding. They will be informed that the study is designed to examine the effects of volunteering or 
life review on health and well-being of older adults in the community. They will be informed of their rights as 
research subjects, including the right to refuse to participate in the study, and to withdraw their consent at 
any time, as well as potential risks and benefits of participation, including financial compensation, and 
rights to privacy and confidentiality. Specifically, individuals will be told that questions asked may cause 
them to feel uncomfortable or upset. They will be informed that: they may withdraw from an assessment at 
any time for any reason and still receive full reimbursement for that assessment; and they may withdraw 
from the research study at any time without negative consequences to their treatment in the Strong 
Memorial Hospital healthcare system. Moreover, participants will be informed that they will be asked to 
participate in assessments whether or not they complete treatment, that they will be financially 
compensated for participation in assessments whether or not they complete treatment that they have the 
right to refuse to participate in any study assessment session. Subjects will be compensated for the 
assessment sessions for their time and effort ($50 for the baseline interview, $10 for the REDCAP internet-
based/mail survey follow-ups at 3 and 9 months and $35 for 6 and 12 month follow-up in person 
interviews). Data storage and safety will also be described to them. Informed consent will also include 
information about costs of volunteering/life review (i.e., no cost). The process of random assignment will be 
described to subjects as “the flip of a coin.”
o
Subjects will be informed that study staff will perform an immediate evaluation of their dangerousness 
towards self or others should safety concerns arise during assessments. Subjects will also be 
informed that their confidentiality may be breached should concerns arise about their dangerousness 
to self or others. Finally, they will be informed that suspected child abuse will be reported, as 
mandated by law.
o
A small minority of participants may experience elder abuse. In the case of suspected elder abuse, 
subjects will be given an immediate referral to the Elder Abuse Prevention Program (EAPP) of 
Rochester, which provides crisis intervention services. A phone call will be made to the primary care 
provider. Any suspected cases of elder abuse will be immediately reviewed with the PI before the 
subject leaves. The PI will also be in contact with Dr. Conwell regarding potential imminent 
dangerousness, which may involve the use of emergency services and law enforcement authorities. 
o
When obtaining informed consent, a “Determination of Capacity for Informed Consent” protocol 
developed will be utilized. The consent form will be read aloud to subjects, who will be encouraged 
to ask questions throughout the process. At the conclusion of the consent process and prior to 
requesting that they sign the form, all clients are asked the following questions:

Could you please tell me what this study is about?

What are the potential risks to you of participating in this study? 

What are the benefits for participating in this study? 

Do you understand that your participation in this study is voluntary and that you may stop at 
any time or not answer any questions that you feel uncomfortable answering? 

Do you have any questions about the interview or the treatment? 

If in answering these questions the subject is unable to demonstrate an understanding or 
appreciation of the issues, the investigator and subject further review the consent form and 
repeat the pertinent questions. Subjects who achieve a demonstrated understanding of the 
study are determined to have capacity to provide informed consent. For those who do not, 
they are thanked for their time, informed that they are not eligible for the study, and provided 
reimbursement for the assessment.  Subjects’ answers are characterized on a checklist that 
is kept with the research record as documentation of the consent process.

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5.
Confidentiality: Limits and Precautions
The present study includes a documented plan for the collection, storage, protection and analysis of research 
data. The key components of this plan include restriction from unauthorized access to identifiable subject data, 
storage of data to protect against inadvertent loss, and use of appropriate database software tools to maintain 
integrity of data for subsequent analyses. All research files will be coded using a study identification number. 
Subject identifying information and PHI will be stored separately from other data collected for this study and will 
only be accessible by those investigators, Lifespan or University clinicians, or staff who have a need to know this 
information for the purpose of conducting the study. All identifying data will be stored in locked cabinets and 
locked offices or in password-encrypted files. Access to these files is limited to investigators and support 
personnel with the need to enter or analyze data.
All research and clinical information obtained is kept confidential unless the subject is an immediate danger 
to him or herself or to others (Note: clinically relevant but not life threatening information may be shared with 
outside personnel with subject permission). During crisis situations, this clinical information may be provided to 
other clinicians (or family members) in order to facilitate appropriate treatment and minimize the risks of self-
harm or harm to others. This information may include the subject's clinical diagnosis, psychiatric and medical 
history, current medication and treatment status, response to psychiatric or substance abuse treatment, financial 
and social resources, and history of suicidal behavior, if known. 
If study personnel identify inappropriate treatment practices by an outside professional (e.g., inappropriate/ 
dangerous medication combinations given to a vulnerable elder) key study personnel will be consulted and a 
course of action will be planned that balances subject confidentiality with his or her safety. Normally, consent will 
be obtained from the subject to speak to the other treating professional and express concerns. If the subject 
refuses to provide consent to speak with the professional, the degree of danger to the subject will be the primary 
barometer to determine the appropriate steps.
6.
Certification of Research Personnel in the Protection of Human Subjects 
In order to ensure appropriate human research knowledge, all study personnel interacting with subjects or 
with access to subject research will have completed mandatory training in the protection of human research 
participants per guidelines issued by the U. S. Department of Health and Human Services, Office for Human 
Research Protections (see http://ohrp.osophs.dhhs.gov/) and per guidelines of the University of Rochester 
Medical Center. Any additional personnel will complete this training before interacting with study subjects. 
Consistent with University of Rochester Research Subjects Review Board (RSRB) policy, all investigators 
and research staff will complete certification by the RSRB—required completion of a course that contains seven 
modules dealing with topics such as “Ethics and Federal Regulations,” “Roles and Responsibilities of the 
Investigator and the Study process,” and “Roles and Responsibilities of Institutions in Human Subjects 
Research,” among others. The program provides a substantial resource to the investigator for understanding the 
ethics and regulations governing research with human subjects. 
It is also University of Rochester policy that all research and clinical staff who may be in contact with protected 
health information (PHI) demonstrate a working understanding of the University of Rochester's Notification of 
Health Policies and Practices form. This information form describes to patients and research subjects the 
University's policies and procedures regarding PHI, consistent with the federal Health Insurance Portability and 
Accountability Act (HIPAA) and with other relevant university regulations and local, state, and national legislation. 
All investigators and research staff will complete an information and training session on HIPAA legislation, the 
University's Notification of Privacy Practices, and on ethical conduct of research in accordance with this 
legislation and with University regulations. This training session will be developed, in tandem, by training staff in 
the Department of Psychiatry and by the HIPAA compliance officer for Lifespan.
7.
Potential Benefits to the Subjects
Half of the study subjects will receive a volunteering intervention aimed to reduce loneliness – an intervention 
that targets a significant risk factor for reduced well-being, morbidity and mortality. The other half of subjects 
will receive an evidence based life review intervention that has demonstrated benefits for well-being. Thus, 
the potential benefit to the individual may be significant. Subjects may additionally benefit from participating 
in research interviews and completing the questionnaire measures, as these assessments provide them with 

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the opportunity to be carefully listened to and comprehensively evaluated. They may further benefit from 
feelings of altruism connected with participation in research designed to better understand the mental health 
needs and experiences of community-residing older adults. Given the minimal risks associated with the 
proposed research and the substantial gains both to the individual and older adults more broadly, benefits 
appear to outweigh the risks.
8.
Importance of the Knowledge to be Gained
There is a pressing public health need to find interventions that reduce loneliness in later life. Reducing 
loneliness would significantly improve the lives of older adults by improving well-being and promoting health 
and longevity. There is infrastructure nationwide that provides volunteering opportunities and support for 
older adults—the Senior Corps—indicating that volunteering is an accessible intervention for older adults. If 
shown effective at reducing loneliness, dissemination efforts would involve connecting primary care patients 
and aging services clients who are lonely with this type of intervention, which we have shown to be feasible 
in our companion study of older adult peer companionship, The Senior Connection (TSC).  
9.
Alternatives to Participation
Regarding alternative interventions, subjects will not be prohibited from seeking out supportive social services, 
or volunteering their services to others (for ethical reasons), but subjects will be asked to refrain from initiating 
new long-term volunteering experiences during their time in the study. If a subject in the volunteering group 
does engage these services, he/she will be followed for the full 12 months, with documentation of the nature 
and extent of that engagement, and evaluation of its impact on the outcomes of interest.
10. ClinicalTrials.gov Requirements
In line with NIH requirements, we plan to register the trial.
VII. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT
1.
Method of Subject Identification And Recruitment
Recruitment strategies involve:
1) initial contact: 
a.
informational letter sent to home 
b.
flyers and advertisements
c.
HARP database study (RSRB 67245) referrals
d.
In-person recruitment in PCP offices
e.
Direct referral via providing an informational letter from physicians and care managers
f.
Informational Sessions
2) informational phone call; 
3) in-person interview for written informed consent and assessment.
As described in the Procedures section, recruitment via informational letter will involve completing a 
data request (via secure software, and only involving patients within the covered entity), and cleaning 
the data on a secure, password-protected device. A designee from the practice will then be given an 
opportunity to review the list and exclude individuals as needed. After the list of patients has been 
“cleared,” staff from the research team, the Center for Research Support or The University Copy Center 
will prepare and send informational letters to each individual. The letters will briefly explain the study, as 
well as inform potential subjects that their participation is entirely voluntary, and that their decision 
regarding participation in this study will in no way affect their medical care. Additionally, the letter will 
invite those who may be interested to call research staff. 
The phone call will involve providing potential subjects with additional details about the study. For those 
who are willing to continue, the research coordinator will schedule an in-person assessment within five 
business days. During the assessment, the study coordinator will again explain the study and obtain 
written consent for the subject to participate. Baseline assessments will be completed. Finally research 
staff will remind the subject of the randomization process and the assessment follow-up schedule and 
answer any remaining questions. If eligibility can be confirmed by study coordinator at the baseline 

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interview, the study coordinator will randomize the subject at that time.  If there are any eligibility 
concerns, the study coordinator will notify the subject that randomization will happen at a later time. 
After the interview, study staff will review the assessment with the PI. Once determined to be suitable 
for randomization, stuff staff will randomize the subject and call him/her to notify the subject of the 
group to which he/she has been assigned. 
2.
Process of Consent
 The CRC will obtain written consent from subjects before the baseline in-person assessment only after subjects 
have received both verbal and written explanations of the study and indicated their full understanding. They will 
be informed that the study is designed to examine the social supports of older adults in the community, and 
whether people receive benefit from participating in social types of volunteering. They will be informed of their 
rights as research subjects, including the right to refuse to participate in the study, and to withdraw their consent 
at any time, as well as potential risks and benefits of participation, including financial compensation, and rights 
to privacy and confidentiality. Data storage and safety will also be described to them. Finally, the process of 
randomization to one of two conditions will be described; subjects will be told that if they choose to participate 
they will randomly assigned to one of two conditions: volunteering or life review.
3.
Subject Comprehension and Capacity to Consent
A Capacity for Informed Consent protocol will be implemented for all potential participants (see attached 
document: “Determination of Capacity for Informed Consent”). The capacity assessment will consist of a series 
of open ended questions administered to the subject that follow explanation of the study. It will address the 
subject’s knowledge and understanding of the study’s objectives, the voluntary nature of participation, ability to 
withdraw at any time, consequences of withdrawing, possible risks and benefits of participation. For subjects 
who have difficulty in one or more of these areas, further review of the relevant elements of the study will be 
provided in order to improve their knowledge and understanding to a level that enables them to make a 
meaningful choice about participation. A form (i.e., “Determination of Capacity for Informed Consent”) will be 
completed for each subject documenting the results of the decision-making capacity determination, a copy of 
which is maintained with the consent form. 
4.
Debriefing Procedures
At the final 12 month interview, research staff will give those assigned to life review information about 
volunteering. If they are interested, a Lifespan brochure that lists all Lifespan programs and contact information 
will be given to the subject.   
5.
Consent Forms
See attached.
6.
Documentation of Consent
All signed consent forms will be stored in a locked file in a locked office, separate from other non-identifying 
subject data.  Only study staff will have access to these files.  All subjects will receive a signed copy of the 
consent form for their records.
7.
Costs to the Subject
There are no costs to the subject. Parking at URMC will be paid for by the study. For those who take the bus, 
a bus pass will be provided.
8.
Payment for Participation
Participants will be paid $50 for the baseline interview, $10 for each internet-based/mailed/in-person survey 
follow-ups (3 and 9 months), and $35 for in-person interviews at 6 and 12-months. Each participant, 
therefore, may be reimbursed a maximum of $140 for their time and effort.

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Protocol Addendum 2/9/22
HELPING OLDER PEOPLE ENGAGE (HOPE):
A Randomized Trial of Volunteering to Reduce Loneliness in Later Life
Study Protocol for R01AG054457
Due to Covid-19 restrictions, all study visits are remote. These changes will remain in effect until 
URMC/NIH guidance changes regarding research and our high risk population (people over the 
age of 60). We have reassessed safety procedures and obtained DSMP guidance and will allow 
volunteer activities that RSVP has approved for volunteering. These agencies will have a 
documented safety plan and will be reviewed by members of our DSMP Committee. Any subject 
wishing to participate in at home volunteer activities may still continue to do so. Any additional 
changes will be reviewed by our DSMP committee and discussed with program officer before 
we will revert to our original protocol and resume all in-person activities. 
Study visits – Baseline, 6 months and 12 months will be conducted via phone or zoom and 
online.  3 and 9 month surveys will remain remote either online or by phone. If a subject is 
unable or unwilling to use zoom, the visits will be done by phone with self-administered studies 
sent by e-mail.    
Consent – Consent will be done at the baseline visit over the phone or through zoom. At the 
screening call, the study coordinator will ask the subject whether they want to use phone or 
zoom. E-consent will be done through the REDCap module. The study team will obtain verbal 
permission to send the eConsent via email.  Verbal permission will state: “Because URMC can’t 
control the security of email messages once we send them, we need your permission to email 
you. Do you want to receive the link to the eConsent via email?”  The permission will been 
documented. The email will not include PHI.    
To verify the subject’s identity - the study team will add security questions to answer at the time 
of accessing the survey/eConsent. These questions will be pre-established security questions 
such as “What is your favorite color?” or “What is the name of the street you grew up on?” that 
are included on the signature page of the eConsent.  The responses will be agreed upon by 
both the study team and the subject during the screening call. The answers will be saved in the 
subject record for verification later. 
The consent process will be the same as in-person. The consent form will be read aloud to 
subjects, who will be encouraged to ask questions throughout the process. At the conclusion of 
the consent process and prior to requesting that they sign the form, all subjects are asked 
capacity questions prior to signing. Subjects will certify that the information in the document is 
correct (which includes their name), and that electronically signing is the equivalent of signing a 
physical document. Subjects will sign using finger, mouse or stylus. The study coordinator will 
sign electronically as well. Consents will be stored within REDCap, and a copy will be e-mailed 
to the subject.
Intervention – Volunteering will remain through RSVP and may include both in the community 
and at home volunteer activities. Placements in the community are reviewed by RSVP and will 
have a documented safety plan. 
Measures: The only measure that will need some adjustment will be the MOCA. If a subject 
cannot use zoom, a few of the visual questions would not be able to be performed. MOCA 

without the visual elements is considered the Blind version of the test and can be used with a 
modified cutoff score given that the maximum total score for the Blind version is 22 and the full 
version maximum total score is 30. 
We are adding one additional measure that will be completed at every visit (baseline, 3 month, 6 
month, 9 month, 12 month). Because our study is looking at social connectedness, which is 
affected by the pandemic, we are adding a new measure on the pandemic’s effect that was just 
published (Cawton et. Al., 2020).
We are adding an additional measure (Older Adult Social-Evaluative Scale) that will be 
completed at Baseline and 12 months to assess factors that may affect non-compliance with 
intervention.
Inclusion/Exclusion criteria: Subjects must have access to a device and internet to complete 
remote study visits. Those who do not have access to a device/internet will be excluded at this 
time. For subjects who cannot use zoom and will do the MOCA without the visual elements, we 
will use a cutoff score of 15. A score of less than 15 will be used as exclusion for the telephone 
administered MoCA. This cutoff score is equivalent to our cutoff score for the full MOCA based 
on validation studies comparing the MoCA delivered in person with visual elements to the MoCA 
delivered via telephone without the visual elements (Zietemann et al., 2017).
Number of Subjects: The study will recruit and enroll up to 400 subjects into the study. The 
target number of randomized subjects is n=150 in each group. Due to greater than 10% of those 
enrolled being not eligible or not willing to be randomized, we must enroll up to 400 subjects to 
try to reach our target number of randomized subjects. 
Recruitment procedures:
Strategy 2: We are including in this strategy a media press release and essay submission to 
newspaper to reach more potential subjects.  
Strategy 9: We are adding a new strategy to use direct mailing. Sending informational postcards 
through the ‘Every Door Direct Mail® (EDDM®)’ program, which is a program created by the United States 
Postal Service®. The program enables advertisers to reach every address within targeted carrier routes, 
at reduced rates, without the need for additional mailing services or specific lists. We propose to use 
Staples Direct Mail because it is a service that combines printing and mailing for the EDDM process. The 
study team, therefore, will not have access to any names or addresses. This recruitment method allows 
demographic targeting, including by age. Without seeing individual household information, we are able 
to identify which mail carrier routes contain the highest density of adults age 65 and older. However, 
postcards are sent to every address/mailbox within your selected carrier routes. A carrier route is a 
group of addresses used by the USPS® to deliver mail in a specific area. ZIP Codes™ may contain 
anywhere from several to more than a dozen carrier routes depending on the rural or urban nature of 
the region. We can upload the informational postcard approved with this amendment to the Staples 
Direct Mail website, select which carrier routes we should like to use, and the rest is managed by Staples 
Direct Mail. We do not have access to the names/addresses of those sent mail. We propose to use a 

Staples Direct Mail template; a graphic designer at Staples then uploads our approved text information 
into the template. Potential subjects can contact our study team and be screened using the contact 
information on the direct mailing. 
Strategy 10: We are adding a new strategy to use recruitment e-mails sent to patients of Trillium 
Health who are age 60 and older. We have received approval from the Research Steering 
Committee at Trillium Health. An e-mail from Trillium Health with a short description of our study 
along with a link to our study website will be sent to any patient who is age 60 or older. The 
Research Steering Committee has approved the e-mail for this purpose. Our study staff will not 
have access to any Trillium patient information. Trillium staff will create and send the e-mails.
In addition to e-mails, recruitment letters from Trillium Health will be sent to patients of Trillium 
Health who are age 60 and older. We have received approval from the Research Steering 
Committee at Trillium Health. Letters will be generated and sent by staff at Trillium Health, and 
study staff will not have any access to any Trillium patient information. These letters, prepared 
by staff at Trillium Health, will introduce the study including a brochure. The letter will indicate it 
is sent by Trillium Health, and invite those who may be interested to call research staff. These 
letters will state that participation in the study is entirely voluntary, and that participation or non-
participation will not influence one’s medical care. Letters will only be sent to patients once.
In addition to the e-mails and letters, Trillium Health will also list our study on their research 
opportunities webpage. https://www.trilliumhealth.org/patient-and-community-services/research-
opportunities A brief description of the study will be listed along with our contact phone number 
and e-mail address. An approved study recruitment flyer/brochure will also be included on the 
website.
We propose recruiting from Trillium Health to increase diversity and boost recruitment numbers. 
This is in support of an administrative supplement we previously received to increase 
recruitment of SGM (sexual and gender minority) older adults (supplement information 
submitted in modification #5: 4/12/19). E-mails will not be targeting any specific population and 
will be sent to all patients over age 60, however the Trillium population is an enriched sample 
regarding SGM because of who selects care at Trillium.
Strategy 11: We are adding recruitment strategies via our geriatric medicine practices at UR 
Medicine. The UR Medicine Geriatrics Group will place our informational brochures in waiting 
rooms and patient exam rooms. UR Medicine Home Care (URMHC) will share brochures with 
patients who receive their services.  In addition we may contact potentially eligible URMHC 
clients who have indicated that they are interested in participating in research when they 
complete the consent process via URMHC. In 2021, URMHC developed and implemented a 
process for existing URMHC patients to indicate willingness to be contacted about participation 
in research studies. These procedures are part of a clinical workflow conducted by clinicians; 
responses are contained in a clinical database. Using this process, URMHC patients, while 
receiving HHC visits, will be asked if they agree to be contacted by URMC researchers for 
future research participation, knowing that each study will be introduced and consent will be 
sought individually. If the patient agrees to be contacted by URMC research about future 

research opportunities, he/she will choose “yes”, sign, and indicate their preferred contact 
method (i.e., phone, email, or mail). This information has been incorporated electronically, along 
with the signature, in the URMHC electronic health records. Upon IRB approval, URMHC will 
provide a list of URMHC patients who have consented for future research contacts at the time 
for their initial HHC visits, along with their contact information. Study staff will contact those 
patients and explain the study per the verbal script. If interested, the screening questions will be 
completed by phone.
References
Cawton, P., Orwoll, E., Ensrud, K., Cauley, J.A., Kritchevsky, S.B., Cummings, S.R., & 
Newman, A. Assessing the impact of the covid-19 pandemic and accompanying mitigation 
efforts on older adults. J Gerontol A Biol Sci Med Sci. 2020 Apr 20. pii: glaa099. doi: 
10.1093/gerona/glaa099.
Zietemann, V., Kopczak, A., Muller, C., Wollenweber, F.A., & Dichgans, M. (2017). Validation of 
the Telephone Interview of Cognitive Status and Telephone Montreal Cognitive Assessment 
against detailed cognitive testing and clinical diagnosis of mild cognitive impairment after stroke. 
Stroke.  doi: 10.1161/STROKEAHA.117.017519