Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
Phase: NA
Conditions: Social Isolation, Loneliness, Caregiver Burnout
Sponsor: University of Rochester

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
Official Title: Healthy Aging Research Program (HARP): Engage Coaching Project for 
Latinos  
NCT#: NCT04875065  
Document Date: 5/10/21 

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 1 of 11
Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
Study Protocol for: Engage Psychotherapy to Promote Connectedness in Latino Caregivers
A Pilot Study for Year Two of the Rochester Roybal Center for Social Ties and Aging Research 
(P30AG064103) and the UR Healthy Aging Research Program (HARP)
Principal Investigator: Caroline Silva, PhD
Co-Investigators: Maria Quiñones, PhD
I. RATIONALE FOR THE STUDY AND SPECIFIC AIMS
Purpose: This study asks: “what behavioral strategies are needed to help socially disconnected 
Hispanic/Latino caregivers with significant barriers to increasing connectedness?” This study uses a mixed 
methods approach to adapt a brief behavioral intervention—Social Engage psychotherapy—for use with 
socially disconnected Hispanic/Latino caregivers. The ultimate goal is for Social Engage psychotherapy to be 
offered as a second step in a stepped care approach for Hispanic/Latino caregivers who do not demonstrate 
an adequate response to a discussion prioritization tool alone. 
Background: Hispanics/Latinos are expected to constitute 22% of the older adult population in the United 
States (U.S.) by 20601 and approximately half of U.S. Hispanic/Latino older adults mainly speak Spanish.2 
Compared to other racial/ethnic groups, Hispanic/Latinos have the highest prevalence of caregiving, 
experience higher caregiver burden, and spend more time in caregiving-related activities.3 This places 
Hispanic/Latino caregivers at a greater risk to become socially disconnected (loneliness, social isolation) in 
the context of caregiving. Despite this, there are few interventions adapted for Hispanic/Latino caregivers that 
are culturally attuned and available in Spanish, and none have reduced loneliness. 
To our knowledge, only two available programs have been adapted for Hispanic/Latino and Spanish-
speaking caregivers and these are solely focused on increasing health literacy among caregivers for 
psychosis4 and Alzheimer’s disease and related dementias (ADRD).5 One program, Resources for Enhancing 
Alzheimer’s Caregiver Health (REACH), has been culturally-tailored for Hispanic/Latino caregivers with the 
aim of increasing quality of life and decreasing depression.6-9 Importantly, none of the available interventions 
focus on increasing social connectedness for Hispanic/Latino caregivers. 
Social Engage: The current study involves adapting a behavioral intervention for social connectedness —
Social Engage part of the Rochester Roybal Center for Social Ties and Aging Research, which is a research 
center funded by the National Institute on Aging (NIA). Social Engage psychotherapy (“Engage Coaching”) 
involves psychoeducation on the importance of social connections for health as well as structured goal 
setting for increasing social connectedness (see Section III: Methods and Procedures, f) Study Conditions 
and Figure 1 for further description). The STAR Center adapted Social Engage for caregivers to help improve 
connectedness among older caregivers of individuals with ADRD (see RSRB STUDY00004244). We will 
tailor Social Engage for Hispanic/Latino caregivers and Spanish-speaking caregivers guided by the Selective 
and Directed Treatment Adaptation Framework. This study aligns with the STAR Center mission to support 
the social well-being and healthy aging of those caring for a family member or loved one with ADRD, 
particularly Hispanic/Latino caregivers, and will apply a cultural adaptation model for behavioral interventions 
to promote social connection in this understudied and vulnerable population
Overview of the Design: This study is a single-arm clinical trial of Social Engage psychotherapy. We 
propose to enroll 30 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up 
to 3 months. Subjects will be aged 40 and older, and be Hispanic/Latino caregivers for a loved one with 
ADRD and experiencing elevated caregiving distress and/or social disconnectedness. This pilot study has 
been approved by NIA. This study is part of the Healthy Aging Research Program (HARP) of the University of 
Rochester and will use HARP recruitment infrastructure and procedures.
Specific Aims & Hypotheses:
Aim 1: To examine feasibility of Engage Coaching for Hispanic/Latino caregivers: are socially disconnected 
Hispanic/Latino caregivers willing and able to complete Engage coaching?

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 2 of 11
H1a: We expect at least 80% of caregivers screened will report willingness to enroll in Social Engage 
psychotherapy (based on our previous study of Social Engage with isolated older adults).
H1b: We expect at least 75% of participants will complete Social Engage psychotherapy (at least 80% of 
expected sessions).
Aim 2: To address specific needs of Hispanic/Latino caregivers: what strategies are best suited to 
addressing barriers to social engagement for Hispanic/Latino caregivers?
H2a: We will systematically track strategies that caregivers and Social Engage therapists utilize to address 
both structural barriers to social engagement (e.g., lack of time, difficulties leaving the care receiver home 
alone) and relational barriers (e.g., decreased relationship satisfaction). We will also conduct qualitative 
interviews with participants at 3 months to learn which strategies they perceive as most helpful. 
Aim 3: To examine potential efficacy of Engage with cultural tailoring by examining satisfaction with the 
intervention and changes in social connectedness over the course of therapy. 
H3a: We will obtain qualitative and quantitative feedback from participants about ways in which Engage 
helped (or did not help) them increase social connectedness, including assessments of Self-Determination 
mechanisms of change—autonomy, competence, and relatedness.
H3b: We will measure a behavioral indicator of connectedness (quality and quantity of positive social 
interactions), a psychological indicator of connectedness (loneliness), and indicators of well-being over the 
course of treatment and at 6-month follow-up to estimate the length of treatment needed for improvement; to 
estimate the proportion of participants who respond to treatment; and the proportion who maintain gains after 
treatment (to inform a fully powered, randomized efficacy trial).
II. CHARACTERISTICS OF THE RESEARCH POPULATION
a) Number of Subjects: We will enroll approximately =30 participants, anticipating n=24 will begin the 
intervention (considering exclusion criteria, interest in the intervention) and n=20 participants will provide 
follow-up data and complete a full course of Social Engage. Subjects will be Hispanic/Latino caregivers (age 
40 or older) for a loved one with ADRD, living with (or in close proximity to) the loved one with dementia. 
They will be recruited from the IRB approved Health Aging Research Program (HARP) Population Study 
(RSRB00068059) (see III-d Recruitment Procedures) and Research Match.
b) Gender, Age, Racial, and Ethnic Origin of Subjects: 
All participants will be Hispanic/Latino. Women will be well-represented in this study. Caregivers in the US 
are more likely to be women (67%); We will proactively recruit minority participants (including targeting men 
for enrollment, as they represent the gender minority in the caregiver population) using best practices for 
minority recruitment, including working with providers serving minorities; collaborating with community 
gatekeepers; tailoring the recruitment materials to the culture and education level in inner city populations. 
  
c) Inclusion Criteria (assessed at the HARP screening assessment):
1.
Age ≥ 40 yrs; 
2.
Hispanic/Latino
3.
English or Spanish speaking; 
4.
Caregiver for a loved one with ADRD; 
5.
Endorse elevated caregiving distress as measured by a score of ≥ 2 on item 3 of the 10-item 
Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain 
Index (MCSI); 
6.
Endorse clinically significant loneliness as measured by a score of ≥ 4 on the UCLA 3-Item Loneliness 
Scale.
7.
Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this 
study.
d) Exclusion Criteria (assessed at the HARP screening assessment): 

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1.
Primary language is not English or Spanish; 
2.
Recent or current psychosis;
3.
Significant cognitive impairment on a cognitive screening measure at the HARP screening 
assessment;
4.
Hearing problems that preclude completion of the intervention.
e) Vulnerable Subjects: Individuals who are 40 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 at improving mental health treatment for older Hispanic/Latino caregivers.
III. METHODS AND PROCEDURES
a) Design: This study is a single-arm clinical trial of Social Engage psychotherapy. We will enroll n=30 
participants. Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions by 
Zoom. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two 
weeks without meeting to address life stressors such as illnesses that may pop up. The first and last session 
are longer – up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Participants will 
complete follow-up assessments at 3-months (phone/Zoom and online via REDCap) and 6-months (online 
via REDCap or by phone).
The study team will remain vigilant about any further changes that need to be made to study procedures if 
there are changes to the research reboot guidance found here: 
https://www.urmc.rochester.edu/coronavirus/coronavirus-research/guidance-for-researchers/human-subjects-
research.aspx
b) Intervention Setting: The assessments and intervention will be remote by phone/Zoom/online. 
c) Recruitment Setting and Procedures: Subjects will be recruited via the IRB approved HARP Population 
Study (RSRB00068059), a research registry run by the current study’s Investigators. In compliance with 
procedures of the Population Study protocol, subjects of the Population Study consent to allow HARP 
Population Study researchers to share subjects’ identifiable data (both name and contact information) with 
investigators conducting HARP research at the University of Rochester; in addition, they consent to allow 
their data collected as part of the Population Study to be included in their research record for subsequent 
HARP studies they participate in, including the current study. All eligible participants will be given information 
about this study at their HARP in-person assessment. Contact information is collected and maintained via the 
IRB approved HARP Database Study. A brochure (available in English and Spanish) describing the study will 
be given to participants in the HARP Population study (brochure is uploaded in the rsrb online application). 
Information about the study will also be provided on ResearchMatch (Request-the-use-of-
ResearchMatch_March2020 is uploaded in the rsrb online application) and the URMC Clinical Trials website, 
the UR STAR Center and URMC HOPE lab webpage (webpage info is uploaded in the rsrb online 
application). Information about this study will also be provided at URMC affiliated primary care and 
ambulatory psychiatry clinics, and community partners (Lifespan, Ibero) via brochures/flyers (flyer is uploaded 
in rsrb online application). We will also provide information about the study in a newspaper and/or radio 
advertisement (newspaper/radio ad info are uploaded in rsrb online application). We will utilize a REDCap 
eligibility screening survey given the relatively low base rate of loneliness, which is our key inclusion criteria, 
to increase the efficiency of our screening/enrollment process. Individuals who complete this survey and 
endorse loneliness (UCLA 3-Item Loneliness Scale) and/or at least mild stress will have the option to provide 
their contact information to share with the Healthy Aging Research Program (HARP) staff to complete the 
HARP Database (RSRB00067245) and Population Study (RSRB00068059) assessments (also available in 
English or Spanish), which will provide information needed to determine final eligibility for this Engage 
Coaching study, which is part of the Rochester Roybal Center for Social Ties & Aging Research. 

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 4 of 11
e) Assessment Measures & Administration Schedule: The following list specifies the assessment 
measures we propose to collect at follow-up assessments, with assessments conducted in English or 
Spanish at both 3 and 6 month follow-up unless otherwise specified:
Domain 1, Social connectedness: Loneliness scales (UCLA Loneliness Scale and DeJong Loneliness 
Scale); Berkman-Syme Social Network, Unidimensional Relationship Closeness Scale, PROMIS social 
functioning computerized adaptive tests (satisfaction with roles/activities, social isolation, meaning/purpose, 
companionship, emotional support, instrumental support.
Domain 2, Caregiving: Montgomery Borgatta Caregiver Burden Scale, Modified Caregiver Strain Index 
(MCSI), Caregiver Reaction Scale
Domain 3, Health indicators: WHODAS, PROMIS computerized adaptive tests of depression, anxiety, 
fatigue and pain interference; Modified Cornell Services Index (only 3 month); Neuropsychiatric Inventory 
(only 3 month), FAST (only 3 month) Modified Barthel Index (only 3 month), Columbia Suicide Severity 
Rating Scale (only 3-month).
Domain 4, Well-being indicators: WHOQOL-BREF is a 36-item measure of several domains of health 
related quality of life
Domain 5, Mechanisms of behavior/social connectedness change. Interpersonal Needs Questionnaire 
(INQ); the PSS-10 measures perceived stress.
Domain 6, Feedback about intervention 
Participations will be provided an opportunity 
to discuss what they liked and did not like 
about the intervention, including what 
aspects they found helpful. This part of the 3 
month interview will be recorded on Zoom. A 
short self-administered feedback 
questionnaire will be completed at 6 month 
follow-up.
f) Study Conditions: This study is a single-
arm clinical trial of Social Engage 
psychotherapy. Social Engage 
psychotherapy has demonstrated increases 
in well-being and social engagement for 
lonely older adults in a previous study 
conducted at URMC (K23MH096936; Van 
Orden). Social Engage psychotherapy 
involves psychoeducation on the importance 
of social connections for health as well as 
structured goal setting for increasing social 
connectedness. The study PI will train and supervise study therapists as done in the prior study. Therapists 
and the PI will work together to devise caregiver specific barrier strategies as needed, such as brief 
communication skills coaching or education on behavioral issues in dementia. The development and piloting 
of these new caregiver specific barrier strategies is a key objective of this pilot study. Figure 1 describes the 
content, objectives, and tasks of each Engage session.
g) Analytic Procedures: Participants will be characterized with regards to demographic characteristics, 
degree of social disconnectedness, caregiver distress, well-being (depressive symptoms, quality of life), 
cognitive function, and relationship satisfaction with the person they care for. For Aim 1 the number of 
subjects and the number of sessions completed by each will be examined to determine if at least 80% of 
subjects will be willing to start Social Engage and at least 75% complete a full dose of the intervention. Aim 2 
is to determine the most useful barrier strategies to use with caregivers. We will tabulate how often each 
strategy is used within and across participants. Qualitative analyses of interview data from participants at 
follow-up regarding their perceptions of effective barrier strategies (Aim 2) and effective/ineffective aspects of 
the therapy in general (Aim 3) will be led by Dr. Silva and follow these procedures: The feedback portion of 
Figure 1. Social Engage psychotherapy for caregivers objectives and tasks.

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 5 of 11
the 3 month interview will be transcribed verbatim using the method described by Easton and colleagues. A 
research assistant will review the accuracy of each transcript and correct any errors, note any extended 
pauses, emotional displays, and/or disruptions (e.g. people leaving the room, telephone calls). The corrected 
transcript will be de-identified, dated, timed, and entered into the Atlas.ti8.01a data management software 
program. We will use a phased approach to data analysis. During phase 1 we will use an inductive technique 
called open coding. Open coding is a process of identifying and labeling emergent ideas in the text, often 
using the participants’ own language. We will then code for pre-specified domains of social connectedness 
including the structure, function, and quality of caregivers’ social connections and their barriers and 
facilitators. Subsequently, we will develop a coding scheme reflecting both emergent and pre-specified 
domains. During phase 2 we will code all transcripts with our coding scheme. Finally, during phase 3 we will 
examine for patterned variation based on high or low scores of social connectedness, first within each group 
and then across the two groups.
Aim 3 is to obtain evidence for a signal for efficacy with regards to social connectedness. Baseline data from 
the assessment battery will be used: a behavioral indicator of social connectedness (quality and quantity of 
positive social interactions), a psychological indicator of connectedness (loneliness), mechanisms of change 
(autonomy, competence, and relatedness), and indicators of well-being (psychological distress and quality of 
life). Assessments will be completed at the end of intervention (3 months), and 6-month follow-up. Follow-up 
data will be used to estimate the length of treatment needed to demonstrate improvement and to estimate the 
proportion of participants who demonstrate increases in social connectedness by the end of the intervention 
and the proportion who maintain gains after the intervention. Our hypotheses will be tested with repeated 
measures ANOVAs with the Stata software package; significant increases support a signal for efficacy. 
h) Data and Safety Monitoring Plan: See Data and Safety Monitoring Plan document.
i) Data Storage & Confidentiality: 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. 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. Silva 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. Silva. 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. Audio-visual recordings of semi-structured 
interviews will be transcribed and then destroyed to protect the security and confidentiality of identifiable 
information. In order to protect subjects’ privacy, audio-visual recordings will only be made with subjects’ 
written consent; subjects will be free to refuse to answer any questions they would prefer to not answer; 
interviews will be conducted in private settings. If a subject only wants to have audio recordings done, the 
subject can choose to disable the video function in Zoom or call into Zoom by telephone only. Engage 
sessions will be recorded for supervision of therapists and to identify strategies that are best suited to 
addressing barriers to social engagement for caregivers. The data on the recording will be identified only by 
an ID number. Recordings for the ENGAGE sessions will be uploaded onto UR Box.
IV. RISK BENEFIT ASSESSMENT
1. Risk Category: Minimal risk for all procedures.
2. Potential Risks: 

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 6 of 11

For research assessments—self-report questionnaires and semi-structured interviews—the primary 
risk is invasion of privacy (including because study staff may send email reminders of assessment 
visits), breach of confidentiality (if safety issues are detected), or mild reactions of distress or 
fatigue. Given that assessments and intervention are conducted/provided in the subjects’ homes 
through Zoom/phone/online, others could be present, which risks revealing the subject's participation 
in the study; subjects will have full discretion in having others present. All assessment measures and 
procedures have been safely used previous research with older adults; no sustained negative effects 
from assessments are expected, but negative outcomes cannot be ruled out.

For the intervention, Social Engage psychotherapy, the primary risk of is emotional distress or 
fatigue. Subjects may think about stressors, negative life events, and caregiving burden/distress; they 
will receive support from the Engage therapist for such experiences. No sustained negative effects 
are expected, but negative outcomes from behavioral interventions cannot be ruled out. The study PI 
(Dr. Silva) is a licensed clinical psychologist and will provide weekly (and as needed) clinical 
supervision for Engage psychotherapists. Dr. Silva and Dr. Quiñones are  bilingual clinical 
psychologists experienced in working with older adults, including those experiencing emotional 
distress and will be on-call at all times to support therapists and participants as needed.
3. Protection Against Risks
Informed Consent: Once a protocol is approved by the IRB, all study team members must read and 
understand the study protocol, the informed consent form, and the case report forms prior to being involved in 
the informed consent process. The PI of the protocol will practice the consent process with the consent 
designee(s) prior to the enrollment of the first subject. PIs will train the study staff to conduct consent by 
explaining, demonstrating, and observing the consent process until they master the consent process. PIs will 
randomly check the consent process quarterly and re-train staff as needed. 
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. 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. Silva 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. Silva. 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. Zoom audio (or audiovisual) recordings of semi-structured interviews will be transcribed 
and then destroyed to protect the security and confidentiality of identifiable information. Audio (or audio-
visual) recordings of the Engage sessions will be saved and stored on UR Box. 
In order to protect subjects’ privacy, audio-visual recordings will only be made with subjects’ written consent; 
subjects will be free to refuse to answer any questions they would prefer to not answer; interviews will be 
conducted in private settings. If a subject only wants to have audio recordings done, the subject can disable 
the video function in Zoom or call into zoom by telephone only.
Risks associated with emotional distress or fatigue 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 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-

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 7 of 11
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 the PI and Co-I’s past 
research involving older adult populations.  

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. 

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. Siva (or the person covering 
for her), who will maintain a cell phone for this purpose. If neither is available, or if otherwise 
necessary, study staff will connect the subject with supports from: the nation-wide area agencies on 
aging, which provide social services for older adults (via Eldercare Locator, a public service of the 
U.S. Administration on Aging at 1-800-677-1116 or https://eldercare.acl.gov/), the National Suicide 
Prevention Hotline (1-800-273-TALK), or by calling 9-1-1 (as the subject’s physical location will be 
confirmed at the beginning of the session).  
Given that we will be assessing depressive symptoms and subjects may report suicide ideation, the CRC’s 
will be trained in the study’s safety protocol for mental distress, suicide risk, and elder abuse, which involves 
items from the Columbia Suicide Severity Rating Scale and clinical interview. 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 or treatment sessions. 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. Any subject who 
endorses death or suicidal ideation will be asked additional questions to assess his/her safety. Any 
endorsements of active suicidal ideation will involve notifying Dr. Silva for review of risk and protective factors 
and consideration of emergency psychiatric services. Dr. Silva has expertise in suicide and regularly 
conducts research studies with distressed and suicidal Hispanic/Latino adults. While it is expected (based on 
prior research) that only a small minority of subjects for the current study will report significant distress (and 
even fewer suicide ideation or elder abuse), CRC’s will be trained in the study’s safety protocol and data from 
each assessment will be reviewed with Dr. Silva weekly, or more often if needed. 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, or a similar program in their area, as the nationwide Eldercare Locator provides a 
national listing of such programs, which are available in every state through the nationwide Area Agencies on 
Aging—these programs. A phone call may be made to the primary care provider. Any suspected cases of 
elder abuse will be immediately reviewed with the PI before the CRC ends the assessment. Situations 
involving potential imminent dangerousness may involve the use of emergency services and law enforcement 
authorities per discussion above. This safety protocol has been used successfully in Dr. Silva’s prior and 
ongoing studies.
4. Informed Consent Procedures:
Informed consent for the study. Eligible participants will provide informed consent prior to entering the study 
and beginning the intervention. Consent will be done over the phone or through Zoom. Prior to the consent, 
the study coordinator will call the subject and 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 be documented. The email will not include PHI.    
To verify the subject’s identity - the study team will add a security question to answer at the time of accessing 
the survey/eConsent. This question will be a pre-established security question such as “What is your favorite 

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 8 of 11
color?” that is needed to access the eConsent.  The responses will be agreed upon by both the study team 
and the subject during the initial call. The answer will be saved in the subject record for verification later. 
The informed consent process will be conducted in a manner to facilitate questions from potential study 
subjects. If a study team member is unable to answer a question, an investigator will be contacted. All 
questions from potential subjects should be answered prior to signature. No subjects will be involved in 
research activities unless an investigator or a designated study staff has obtained documentation of legally 
effective informed consent of the subject. The collection of protected health information (PHI) and 
questionnaires are considered to be research activities requiring prior documentation of informed consent.
Consent will only be sought under circumstances that provide the prospective subject sufficient opportunity to 
consider whether or not to participate and that minimize the possibility of coercion or undue influence. The 
information that is given to the subject or the representative shall be in language understandable to the 
subject. Potential study subjects will be given ample time to read and consider the consent form. All subjects 
will be reminded of the voluntary nature of study participation. Using the consent form to structure discussion, 
research personnel will explain the study, its potential benefits and risks, and alternatives, and document the 
consent process by signature of the subject and the person obtaining consent. 
During informed consent procedures, individuals will be told about possible risks and benefits of participation. 
This will include information 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 receive full 
reimbursement for that assessment; and, they may withdraw from the research study at any time without 
negative consequences. Subjects are further informed that we will perform an immediate evaluation of their 
dangerousness towards self or others should safety concerns arise during assessments or treatment 
sessions. As well, they will be informed that we may contact their primary care physicians should concerns 
arise about medical or psychological risk. The staff will assess the participant’s understanding of the study 
using an IRB-approved adapted version of the San Diego Brief Assessment of Capacity to Consent (UBACC), 
that we have implemented successfully in all of our studies with older adults. If a participant fails to answer all 
questions correctly, the staff will re-explain the study and then test the participant again. The consent will be 
an ongoing process during the study. Explanations of the study and verbal consent will be conducted at each 
data collection. Participants will be reminded that their participation is voluntary and that they can withdraw at 
any time for any reasons.
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’s name and timestamp will be saved in REDCap as their signature. Consents 
will be stored within REDCap, and a copy will be e-mailed to the subject.
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 a 
Certificate of Confidentiality from the Department of Health and Human Services (DHHS), 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 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 

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 9 of 11
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.
7. Potential Benefits to the Subjects: All study subjects will receive a behavioral intervention aimed to 
increase social connectedness and reduce loneliness – an intervention that targets a significant risk factor for 
reduced well-being, morbidity and mortality. 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 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.
8. Importance of the Knowledge to be Gained: Importance of the knowledge to be gained from the 
proposed research: There is a pressing public health need to find interventions that reduce loneliness in later 
life, which is associated with significant morbidity and mortality among older adults who are caregivers. There 
are no evidence-based interventions for promoting social connectedness in older adults. Reducing loneliness 
and promoting connectedness would significantly improve the lives of older adults who are caregivers by 
improving well-being and promoting health and longevity. 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.
9. Alternatives to Participation: Regarding alternative interventions, subjects will not be prohibited from 
seeking out supportive social services, or mental health services (for ethical reasons). If subjects do engage 
these services, he/she will be followed for the full 6 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: This study will be registered at clinicaltrials.gov

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 10 of 11
VII. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT
1. Method of Subject Identification And Recruitment: Subjects will be recruited via the IRB approved 
HARP Population Study (RSRB00068059), a research registry run by the current study’s Investigators. In 
compliance with procedures of the Population Study protocol, subjects of the Population Study consent to 
allow HARP Population Study researchers to share subjects’ identifiable data (both name and contact 
information) with investigators conducting HARP research at the University of Rochester; in addition, they 
consent to allow their data collected as part of the Population Study to be included in their research record for 
subsequent HARP studies they participate in, including the current study. All eligible participants will be 
provided with a study brochure (brochure is uploaded in the rsrb online application). Information about the 
study will also be posted on the PI’s URMC lab webpage (content to be displayed is uploaded in the rsrb 
online application) and the URMC Clinical Trials website. Information about this study will also be provided in 
the ResearchMatch registry. We will utilize a REDCap eligibility screening survey given the relatively low 
base rate of loneliness, which is our key inclusion criteria, to increase the efficiency of our 
screening/enrollment process. Information about the study will be included at the beginning of the survey. 
Individuals who complete this survey and endorse loneliness (UCLA 3-Item Loneliness Scale) and/or at least 
mild stress will have the option to provide their contact information to share with the Healthy Aging Research 
Program (HARP) staff to complete the HARP Database (RSRB00067245) and Population Study 
(RSRB00068059) assessments, which will provide information needed to determine final eligibility for this 
Engage Coaching study, which is part of the Rochester Roybal Center for Social Ties & Aging Research. The 
link to the eligibility screen will be available via research match, the URMC Clinical Trials website, and the 
URMC website with information about the study.
2. Process of Consent: Consent will be done over the phone or through Zoom in participant’s preferred 
language (i.e., English or Spanish). Eligible participants will provide informed consent prior to study start. E-
consent will be done through the REDCap module. An agreed upon security question will be used for the 
subject to access the E-consent.  The informed consent process will be conducted in a manner to facilitate 
questions from potential study subjects. If a study team member is unable to answer a question, an 
investigator will be contacted. All questions from potential subjects should be answered prior to signature. 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’s name and timestamp will be saved in 
REDCap as their signature. Consents will be stored within REDCap, and a copy will be e-mailed to the 
subject (or mailed if email is not an option). No subjects will be involved in research activities unless an 
investigator or a designated study staff has obtained documentation of legally effective informed consent of 
the subject. The collection of protected health information (PHI) and questionnaires are considered to be 
research activities requiring prior documentation of informed consent. Consent will only be sought under 
circumstances that provide the prospective subject sufficient opportunity to consider whether or not to 
participate and that minimize the possibility of coercion or undue influence. The information that is given to 
the subject or the representative shall be in language understandable to the subject. Potential study subjects 
will be given ample time to read and consider the consent form. All subjects will be reminded of the voluntary 
nature of study participation. Using the consent form to structure discussion, research personnel will explain 
the study, its potential benefits and risks, and alternatives, and document the consent process by signature of 
the subject and the person obtaining consent. During informed consent procedures, individuals will be told 
about possible risks and benefits of participation. This will include information 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 receive full reimbursement for that assessment; and, they may 
withdraw from the research study at any time without negative consequences. Subjects are further informed 
that we will perform an immediate evaluation of their dangerousness towards self or others should safety 
concerns arise during assessments or treatment sessions. As well, they will be informed that we may contact 
their primary care physicians should concerns arise about medical or psychological risk.

Silva (PI); STUDY00006126 Engage Coaching; 5/10/21; Page 11 of 11
3. Subject Comprehension and Capacity to Consent: The staff will assess the participant’s understanding 
of the study using an IRB-approved adapted version of the San Diego Brief Assessment of Capacity 
to Consent (UBACC), available in English or Spanish, that we have implemented successfully in previous 
studies with older adults. If a participant fails to answer all questions correctly, the staff will re-explain the 
study and then test the participant again. At follow-up assessments, study staff will review relevant parts of 
the consent form with subjects and will remind subjects that their participation is voluntary and that they can 
withdraw at any time for any reasons.
4. Debriefing Procedures: At the final interview, the CRC will answer any questions subjects have about the 
study. Given the lack of deception, more formal debriefing procedures are not indicated.
5. Consent Forms: See attached.
6. Documentation of Consent: Consents will be stored within REDCap, and a copy will be e-mailed to the 
subject.
7. Costs to the Subject: There are no costs to the subject. Parking at URMC will be paid for by the study.
8. Payment for Participation: Participants will be paid $60 for an internet-based/phone/Zoom survey follow-
up at 3 months and $30 for an internet-based/phone follow-up at 6 months. 
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