SUPeRFOOD: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
Phase: NA
Conditions: Cardiac Rehabilitation, Nutrition, Healthy, Nutrition Poor
Sponsor: University of California, San Francisco

 
 
 
SUPeRFOOD Study 
Version 1.4 
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SUPeRFOOD: enhanced SUPport for 
initiation and paRticipation in a FOOD is 
medicine program 
 
 
 
 
 
Principal Inves=gator:  Alexis BeaCy, MD, MAS 
 
 
 
Phone: 415-476-2300 
Fax: 415-514-8150 
Email: alexis.beaCy@ucsf.edu 
 
 
 
 
Ins=tu=on: University of California, San Francisco (UCSF) 
 
Community Partner: Project Open Hand (POH) 
 
Sponsor: American Heart Associa=on (AHA) 
 
Protocol Number: N/A 
 
Clinicaltrials.gov: NCT06500962 
Version History 
Version 
Date 
Summary of Changes 
1.0 
2/16/2024 
Ini=al version submiCed to IRB 
1.1 
3/22/2024 
Modiﬁed data sharing language to match sponsor 
language. 
Modiﬁed primary objec=ve and endpoint of phase 2 to 
be acceptability based on sponsor feedback. Original 
outcomes are retained as secondary outcomes. 
Added poten=al recruitment through ﬂiers, phone calls, 
or in-person contact. 
Removed collec=on of electronic health record data by 
FHIR. 
Clariﬁed inconsistencies, typos, references. 
1.2 
07/3/2024 
Added measurements to include AHA common data 
elements. Modiﬁed recruitment procedures to comply 
with UCSF requirements. 

 
 
 
SUPeRFOOD Study 
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1.3 
10/11/2024 
Added addi=onal exclusion to exclude pa=ents who are 
currently receiving services from Project Open Hand. 
1.4 
11/26/2024 
Added clinicaltrials.gov number  
Modiﬁed inclusion criteria to include pa=ents who have 
had at least one CR session within the last year at UCSF 
or ZSFG, and to include pa=ents who have internet or 
smartphone access. 
Added language describing new recruitment methods. 
Updated Table 2 to include addi=onal data collec=on on 
FIM meal units for par=cipants’ insurance authoriza=on 
period and dependents. 
 
 
 

 
 
 
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Table of Contents 
Version History ........................................................................................................................ 1 
Abbrevia2ons ......................................................................................................................... 5 
Protocol Synopsis .................................................................................................................... 6 
Background and Ra2onale ...................................................................................................... 8 
Preliminary Studies ............................................................................................................... 10 
Objec2ves ............................................................................................................................. 10 
Study Hypotheses ................................................................................................................. 10 
Study Design ......................................................................................................................... 11 
Endpoints .............................................................................................................................. 11 
Par2cipant Selec2on ............................................................................................................. 11 
Study Procedures .................................................................................................................. 12 
Phase 1 Recruitment ...................................................................................................................... 12 
Phase 1 Screening and Consent ...................................................................................................... 12 
Phase 1 Human-Centered Design Sessions ..................................................................................... 12 
Phase 1 Par:cipant Compensa:on ................................................................................................. 12 
Phase 2 Recruitment ...................................................................................................................... 12 
Phase 2 Screening and Consent ...................................................................................................... 13 
Phase 2 Randomiza:on .................................................................................................................. 13 
Phase 2 Blinding ............................................................................................................................ 13 
Phase 2 eVisits ............................................................................................................................... 13 
Phase 2 Par:cipant Compensa:on ................................................................................................. 15 
Comparators ......................................................................................................................... 15 
Adverse Experience Repor2ng and Documenta2on ............................................................... 16 
Adverse Events .............................................................................................................................. 16 
AE Severity .................................................................................................................................... 17 
AE Rela:onship to Study Interven:on ............................................................................................ 17 
Serious Adverse Experiences (SAE) ................................................................................................. 18 
Serious Adverse Experience Repor:ng ........................................................................................... 18 
Discon2nua2on and Replacement of Par2cipants ................................................................. 18 
Protocol Viola2ons ................................................................................................................ 19 
Data Safety Monitoring ........................................................................................................ 19 

 
 
 
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Analysis Methods .................................................................................................................. 19 
Cost Es2ma2on ..................................................................................................................... 20 
Data Collec2on, Reten2on, and Monitoring .......................................................................... 21 
Data Collec:on Instruments ........................................................................................................... 21 
Data Management Procedures ....................................................................................................... 22 
Data Quality Control and Repor:ng ............................................................................................... 22 
Archival of Data ............................................................................................................................. 22 
Availability and Reten:on of Inves:ga:onal Records ..................................................................... 22 
Monitoring .................................................................................................................................... 22 
Par:cipant Conﬁden:ality ............................................................................................................. 23 
Data Sharing .................................................................................................................................. 23 
Administra2ve, Ethical, and Regular Considera2ons ............................................................. 23 
Protocol Amendments ................................................................................................................... 23 
Ins:tu:onal Review Boards and Independent Ethics CommiSees .................................................. 24 
Informed Consent .......................................................................................................................... 24 
Role of the Sponsor ............................................................................................................... 25 
References ............................................................................................................................ 26 
 
 
 
 

 
 
 
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Abbrevia0ons 
 
AHA 
 
 
American Heart Associa=on 
CR 
 
 
Cardiac Rehabilita=on 
CV 
 
 
Cardiovascular 
EHR 
 
 
Electronic Health Record 
FHIR 
 
 
Fast Health Interoperability Resource 
FIM 
 
 
Food is Medicine 
MTG 
 
 
Medically tailored groceries 
MTM  
 
Medically tailored meals 
POH 
 
 
Project Open Hand 
UC 
 
 
Usual Care 
UCSF  
 
University of California, San Francisco 
 
 

 
 
 
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Protocol Synopsis 
Title 
SUPeRFOOD: enhanced SUPport for ini=a=on and paR=cipa=on in a 
FOOD is medicine program 
Sponsor 
American Heart Associa=on (AHA) 
Site 
UCSF 
Ra=onale 
Food is Medicine (FIM) interven=ons improve quality of life, improve 
cardiovascular risk factors, reduce hospitaliza=ons, and reduce 
healthcare costs, but ques=ons remain about op=mal approaches for 
referral, ini=a=on, engagement, and reten=on in FIM programs to 
improve par=cipa=on and ul=mately health outcomes. 
Study Design 
Two phase study: 
• Phase 1: Human-centered design 
• Phase 2: 2x2 factorial randomized clinical trial 
Objec=ves 
• Phase 1: Optimize the design of the text-messaging and 
navigation interventions. 
• Phase 2:  
§ To determine the acceptability of navigation to 
encourage participation in a FIM program. 
§ To determine the acceptability of text messaging to 
encourage participation in a FIM program. 
Target Par=cipant 
Enrollment (Total) 
• Phase 1: up to 6 per session, up to 18 participants total 
• Phase 2: 84 
Par=cipant Selec=on 
Criteria 
Inclusion Criteria 
1. Age 18 or older 
2. Attended at least 1 cardiac rehabilitation session in the last 
year at UCSF or ZSFG 
3. Has access to the internet or a smartphone 
4. Able to communicate in English or Spanish 
5. Resident of San Francisco County 
Exclusion Criteria 
1. Enrolled in hospice 
2. Unable to consent for self 
3. Currently receiving Project Open Hand services 
 
Dura=on of 
Par=cipant 
Par=cipa=on 
• Phase 1: 1-6 2-hour sessions over 3 months 
• Phase 2: 3 months 
Comparators 
• Navigation 
• Text-messaging 
• Usual care (UC) 

 
 
 
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Study Visits 
• Phase 1: 1-6 2-hour sessions over 3 months 
• Phase 2: Entirely remote study visits through Eureka 
Primary Endpoint 
• Satisfaction with the intervention. 
Secondary Endpoints 
• Number of FIM meals received within 3 months, the 
propor=on of pa=ents ini=a=ng and engaged in the FIM 
program (received at least 1 and 8 FIM meals in 3 months, 
respec=vely), number of CV events in 3 months, and changes 
from baseline to 3 months in self-eﬃcacy, food security, 
healthy ea=ng, quality of life, and cardiovascular risk factors. 
 
Study Hypotheses 
• Primary:  
o Naviga=on + UC (±text messaging) [experimental] will 
result in mean overall sa=sfac=on of >3.5 (scale of 1-
5, with 5 being very sa=sﬁed). 
o Text messaging + UC (±naviga=on) [experimental] will 
result in mean overall sa=sfac=on of >3.5 (scale of 1-
5, with 5 being very sa=sﬁed). 
• Secondary: 
o Naviga=on + UC (±text messaging) [experimental] will 
result in a greater mean number of FIM meals 
received in 3 months than UC (± text messaging) 
[control]. 
o Text messaging + UC (±naviga=on) [experimental] will 
result in a greater mean number of FIM meals 
received in 3 months than UC (± naviga=on) [control]. 
 
 
 
 

 
 
 
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Background and Ra-onale 
Healthy ea=ng prevents cardiovascular (CV) events.1–4 Food is Medicine (FIM) interven=ons 
include medically tailored meals (MTMs), medically tailored groceries (MTGs), and nutri=ous 
food referrals.2,5 In people with chronic disease, FIM interven=ons improve quality of life, 
improve CV risk factors, reduce hospitaliza=ons, and reduce healthcare costs.2,5–9 Many 
ques;ons remain about op;mal approaches for referral, ini;a;on, engagement, and 
reten;on in FIM programs to improve par;cipa;on and ul;mately health outcomes.2 
 
Cardiac rehabilita=on (CR) is a guideline-recommended, mul=-disciplinary program for people 
with heart condi=ons that includes nutri=on counseling.10,11 The 12-week program is an 
opportune =me for people to establish long-term habits. The CR popula=on is well-suited for 
integra=ng and studying FIM programs because 1) CR pa=ents are at risk for CV events, 2) FIM 
programs beneﬁt people with CV condi=ons,5–7 and 3) CR pa=ents are ac=vely engaging in 
behavior change, which may be a beneﬁcial =me for engaging with a FIM program.12 
 
Connec=ng CR and FIM programs oﬀers a scalable opportunity to improve healthy ea=ng and 
health outcomes in people with heart condi=ons. Our long-term goals are to op=mize 
approaches for pa=ents to engage in FIM programs and to examine the eﬀects on health 
outcomes. Our central hypothesis is that enhanced support for pa;ents in addressing barriers 
to par;cipa;on in FIM programs will improve engagement in FIM programs and health 
outcomes. Forma=ve and pilot studies are needed to adapt enhanced support interven=ons to 
diverse heart condi=on pa=ents to inform future larger scale studies to test the eﬀects of these 
interven=ons on health outcomes.  
 
Medically Tailored Meals (MTM): MTMs improve outcomes for those with heart condi=ons, 
especially those unable to plan, shop for and/or prepare healthy food. Studies of MTM show 
improvements in health-related quality of life, diet quality, self-eﬃcacy, food security, and 
cardiovascular (CV) risk factors (e.g., blood pressure and cholesterol).7,13,14 Because of these 
results and pilot programs,15 California now includes MTMs as a Community Supports beneﬁt 
through its state Medicaid program. 
 
Medically Tailored Groceries (MTG) and Nutri=ous Food Referrals: MTGs and food referrals (e.g., 
produce prescrip=ons and nutri=on incen=ves) support people who can prepare their own 
meals. MTG and food referrals, among those who maintain engagement with the programs, can 
increase diet quality and reduce food insecurity.9,16 Though trial-based evidence regarding MTGs 
and produce prescrip=ons is less robust, modeling suggests that incen=ves for fruits and 
vegetables could prevent over 1.9 million life=me cardiovascular disease events and save 
approximately $40 billion in healthcare costs.17  
 
Known barriers to FIM programs: Barriers that impact access to and engagement with FIM 
interven=ons exist at both the health care and par=cipant levels.18 Health care barriers include 
provider awareness, buy-in and ins=tu=onal workﬂows, and staﬃng capacity that support 
referral to and discussion of FIM interven=ons during encounters. Fractured coordina=on of 

 
 
 
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care between the FIM organiza=on and the referring provider/organiza=on can result in loss to 
follow-up or incomplete applica=ons for services. Communica=on with poten=al par=cipants as 
the conduit between the referring provider and the FIM organiza=on places burden on the 
par=cipant, who may already be experiencing signiﬁcant complexity in managing their health. 
During enrollment and throughout FIM service, par=cipants experience a range of access issues 
(e.g., inadequate housing, cooking facili=es, and transporta=on). Cultural appropriateness, taste 
preferences, and language preferences can also inﬂuence access and engagement. Interven=ons 
that include FIM alongside supports that increase knowledge, conﬁdence, and enhance the 
accessibility of services are of cri=cal value for FIM programs.12  
 
Project Open Hand (POH), the community partner for this project, provides nutri=ous meals to 
support medical treatment for people with chronic condi=ons, such as coronary artery disease, 
heart failure, diabetes, recent surgery, and HIV. POH provides both MTM and MTG to 
par=cipants. MTM or MTG can be picked up once per week from the POH facility or mobile van. 
For par=cipants who are unable to pick-up MTM or MTG, the food will be delivered to the 
par=cipant’s home. POH also operates a community nutri=on program where people can 
receive meals in-person at the POH facility. POH works with par=cipants to iden=fy and meet 
dietary needs, including counseling and educa=on from a die=cian. Sample meals can be viewed 
on the POH website. 
 
Interven=on A: Naviga=on: Similar to FIM programs, CR is a beneﬁcial, but underu=lized 
service.19–21 Among the interven=ons that improve par=cipa=on in CR,22 pa=ent naviga=on may 
be the most adaptable to FIM programs. A navigator can guide pa=ents through the system and 
help pa=ents overcome barriers to accessing services. A structured approach to naviga=on in CR 
includes: 1) explain the program, 2) explain the beneﬁts, 3) provide posi=ve endorsement, 4) 
describe process to enroll, 5) welcome ques=ons, 6) address barriers to aCendance, and 7) 
provide follow-up informa=on; this approach may be adapted to FIM.23 Naviga=on ooen 
employs behavioral science strategies, such as mo=va=onal interviewing, to promote self-
eﬃcacy.24–26 Naviga=on can be individualized with regard to pa=ent needs, capabili=es, and 
cultural preferences. To our knowledge, there are no randomized trials of pa=ent naviga=on as a 
strategy to improve ini=a=on and engagement in FIM programs. 
 
Interven=on B: Text messaging: Behavioral science-based text messaging for promo=on of 
health behaviors can improve self-eﬃcacy, health behaviors (e.g., diet quality, steps, tobacco 
use), and CV health outcomes, including blood pressure, cholesterol, and weight.27–30 Text 
messages can be individualized based on programmable algorithms, and the approach may 
have advantages with regard to cost and scalability.  Behavioral science-based text messaging to 
improve par=cipa=on in FIM programs has not been previously studied.  
 
This study will proceed in two phases. In Phase 1, we will conduct human-centered design 
sessions in CR par=cipants to understand barriers to par=cipa=ng in a FIM program and 
op=mize the design of naviga=on and text-messaging interven=ons for addressing these 
barriers. In Phase 2, we will conduct a 2x2 randomized factorial study in people par=cipa=ng in 

 
 
 
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CR comparing naviga=on to usual care and text messaging to usual care with regard to number 
of FIM meals received. 
Preliminary Studies 
In 2022, Project Open Hand (POH) served >477,000 MTM or MTG to almost 3,200 people (15% 
with CV disease). Par=cipants are 35% female and 1% transgender with 27% La=no/Hispanic, 
21% African American/Black, and 5% Asian American/Paciﬁc Islander. Over 80% have an income 
less than $2400/month. Of those enrolled, 64% take home at least seven MTMs each week. 
Outcomes include 89% repor=ng more balanced nutri=on, 55% helping them reach health-
related goals, 51% beCer energy levels, 80% beCer able to manage their health condi=on, and 
66% able to take medica=ons as instructed. 
 
POH collects data on barriers and facilitators using a mul=-dimensional approach based on 
par=cipant ac=vi=es, par=cipant surveys, and interac=ons with staﬀ.31 Barriers include 
appropriateness (available only to limited diagnoses), availability/accommoda=on (limited care 
coordina=on, opera=ng hours, loca=on, challenges in reaching staﬀ), acceptability (food not 
mee=ng preferences), facilita=ng condi=ons (lack of knowledge about cooking, inadequate 
housing/cooking facili=es, lack of social support), and other factors (medical illnesses). 
Facilitators include appropriateness (tailoring service to needs, variety of diets, nutri=onist), 
availability/accommoda=on (rela=onships with referring partners, mobile sites, home delivery 
services, bilingual staﬀ, interpreter services, telehealth op=ons), acceptability (ongoing 
development of culturally appropriate meals/groceries, dietary preferences, treated with 
respect [98%], deliveries on-=me [92%], deliveries accurate [93%]), and responsive client 
services. These barriers and facilitators will guide the ini=al development of the interven=ons. 
Objec-ves 
Phase 1: Op=mize the design of the text-messaging and naviga=on interven=ons. 
 
Phase 2:  
• 
To determine the acceptability of navigation to encourage participation in a FIM program. 
• 
To determine the acceptability of text messaging to encourage participation in a FIM program. 
Study Hypotheses 
Phase 1: Not applicable 
 
Phase 2: 
§ 
Primary: 
o Naviga=on + UC (±text messaging) [experimental] will result in mean overall 
sa=sfac=on of >3.5 (scale of 1-5 with 5 being very sa=sﬁed). 
o Text messaging + UC (±naviga=on) [experimental] will result in mean overall 
sa=sfac=on of >3.5 (scale of 1-5 with 5 being very sa=sﬁed). 
§ 
Secondary: 

 
 
 
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o Hypothesis A: Navigation + UC (±text messaging) [experimental] will result in a greater 
mean number of FIM meals received in 3 months than UC (± text messaging) [control]. 
o Hypothesis B: Text messaging + UC (±navigation) [experimental] will result in a greater 
mean number of FIM meals received in 3 months than UC (± navigation) [control]. 
Study Design 
Phase 1: Conduct human-centered design sessions with CR pa=ents to adapt two enhanced 
support interven=ons to FIM programs: A) naviga;on and B) text messaging. Naviga=on will be 
adapted from approaches known to work for enhancing enrollment and par=cipa=on in CR.22 
Text messages will be based on behavioral science to promote ini=a=on and engagement and 
adapted from previously studied text message libraries.32  
 
 
Phase 2: We will conduct a 2x2 factorial design pilot randomized trial in 84 CR par=cipants to 
compare the eﬃcacy of naviga=on and text messaging interven=ons for increasing par=cipa=on 
in a FIM program (Table 1). All par=cipants will experience usual care (UC): a MyChart message 
with links to the FIM program and study measurement-related text messaging in the Eureka 
Research Plasorm. Addi=onally, par=cipants will be co-randomized 1:1 to A) naviga=on 
(present/absent) and B) enhanced text messaging 
(present/absent), such that 25% of par=cipants will be 
allocated to each of the four interven=on arms. The 
primary outcome will be the number of MTMs or 
MTGs for meals (termed “FIM meals”) received during 
the 3-month study period. We will also evaluate the implementa;on of the interven=ons 
through interviews, review of “ar=facts” of implementa=on (e.g., mee=ng minutes, materials), 
and data on implementa=on inputs, ac=vi=es, outputs, and outcomes using a logic model 
framework.33  
Endpoints 
Phase 1: Not applicable 
Phase 2:  
§ 
Primary endpoint:  Satisfaction with the intervention.  
§ 
Secondary endpoints include the number of FIM meals received in 3 months, the proportion of 
patients initiating and engaged in the FIM program (received at least 1 and 8 FIM meals in 3 
months, respectively), number of CV events in 3 months, and changes from baseline to 3 
months in self-efficacy, food security, healthy eating, quality of life, and Life’s Essential 8 CV risk 
factors. 
Par-cipant Selec-on 
Inclusion Criteria: 
1. Age 18 or older 
2. Attended at least one cardiac rehabilitation session within the last year at UCSF or ZSFG 
3. Has access to the internet or a smartphone 
4. Able to communicate in English or Spanish 
5. Resides in San Francisco County 
Table 1. Four arms of the 2x2 factorial trial 
Usual care (UC) 
UC + Naviga:on 
UC + Text messaging 
UC + Naviga:on + 
Text messaging 

 
 
 
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Exclusion Criteria: 
1. Enrolled in hospice 
2. Unable to consent for self 
3. Currently receiving Project Open Hand services 
Study Procedures 
Phase 1 Recruitment 
We will send a MyChart message to current UCSF CR pa=ents invi=ng them to par=cipate in 
human-centered design sessions.   
 
Phase 1 Screening and Consent 
Pa=ents who respond to the recruitment email will be screened for eligibility based on inclusion 
and exclusion criteria. Par=cipants will be asked to provide wriCen, informed consent. 
 
Phase 1 Human-Centered Design Sessions 
Par=cipants will complete a brief REDCap survey about demographics. We will conduct human-
centered design sessions with CR pa=ents. The human-centered design process will itera=vely 
proceed through 4 phases: discover, deﬁne, develop, and deliver. The process will follow 
principles of technology design for health equity.34 We will conduct 3 design sessions with 
groups of 2-6 CR pa=ents each, audio and video-recorded and transcribed for rapid qualita=ve 
template analysis.35 Groups will be language-concordant. The ﬁrst session will focus on 
discovery and deﬁni=on of pa=ent needs and behaviors related to FIM in the context of the 
Theory of Planned Behavior, following an interview guide.36 Based on this informa=on, we will 
reﬁne the interven=ons. The second session will focus on feedback on draos of the developed 
materials. If signiﬁcant revisions are needed, an addi=onal session will be added. The third 
session will focus on reﬁning the interven=on materials by asking par=cipants to “walk-through” 
the experiences of naviga=on and receiving text messages. If signiﬁcant revisions are suggested, 
addi=onal sessions of itera=ve revision will con=nue.  
 
Phase 1 Par8cipant Compensa8on 
Par=cipants will receive $200 per design session. 
 
Phase 2 Recruitment 
We will give a recruitment ﬂyer to current UCSF CR pa=ents and newly ini=a=ng CR par=cipants 
informing them about Food is Medicine and oﬀering the opportunity to par=cipate in the study. 
Par=cipants may also be recruited to the study from referrals from health care providers, phone 
call from a clinical research coordinator, or contact from a clinical research coordinator in the CR 
center. We will also send a MyChart message to UCSF pa=ents who have had a CR visit within 
the last year. Par=cipants who do not use MyChart will be mailed a paper leCer. Par=cipants will 
be informed that they are 1) eligible for referral to a Food is Medicine program, 2) poten=ally 
eligible for a research study tes=ng diﬀerent ways to help people par=cipate in a Food is 
Medicine program, 3) able to par=cipate in the Food is Medicine program, even if they do not 

 
 
 
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par=cipate in the study. Par=cipants interested in the study will be given a link to join the study, 
which will take them to the Eureka Research Plasorm. 
In addi=on, we will recruit par=cipants who have completed at least one CR session at 
Zuckerberg San Francisco General Hospital (ZSFG) within the last year. Par=cipants at ZSFG may 
also be recruited to the study from ﬂyers, word of mouth, or contact from a clinical research 
coordinator. 
 
Phase 2 Screening and Consent 
Par=cipant screening, consent, and subsequent study par=cipa=on will occur on the Eureka 
Research Plasorm. The par=cipant will answer screening ques=ons based on inclusion and 
exclusion criteria for eligibility conﬁrma=on. The par=cipant will provide eConsent for this 
minimal risk study in Eureka.  
 
Phase 2 Randomiza8on 
Consented par=cipants will undergo two randomiza=ons: 
A) Randomization to navigation or usual care (1:1) 
B) Randomization to text messages or usual care (1:1) 
Par=cipants will be considered enrolled in the study aoer randomiza=on. 
 
Phase 2 Blinding 
The randomiza=on groups of the par=cipant will not be explicitly disclosed to the par=cipant. 
However, since the interven=ons are diﬀerent from usual care, it is possible that the par=cipant 
may infer randomiza=on group. Study staﬀ delivering the naviga=on interven=on will not be 
blinded to group alloca=on for naviga=on, since this will not be possible for the delivery of the 
interven=on. Study staﬀ will be blinded to text-messaging interven=on. POH staﬀ determining 
the number of meals received will be blinded to par=cipant randomiza=on groups. 
 
Phase 2 eVisits 
Par=cipants will complete 2 study eVisits on Eureka. eVisit 1 will occur at the =me of 
randomiza=on. eVisit 2 will occur 3 months aoer randomiza=on. Par=cipants will complete 
ques=onnaires in Eureka (Table 2). If par=cipants have connected health data (e.g., Fitbit, Apple 
Watch), they will be asked to contribute this op=onal data. In addi=on, study staﬀ will abstract 
the electronic health record (EHR) for addi=onal data (Table 2). Aoer the ﬁnal eVisit, the meals 
outcome data will be entered into Eureka via a coordinator form based on POH records. If 
par=cipants are unable to complete eVisits on Eureka, a clinical research coordinator may call 
par=cipants to complete surveys over the phone and enter data into Eureka via proxy data 
entry. 
 
Table 2. Study Measurements 
Measurement 
Ra5onale 
Source 
Month 
 
 
 
0 
3 
Demographics and Health literacy37,38 
Understand characteris:cs of par:cipants. 
Eureka 
x 
 

 
 
 
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Medical condi:ons 
Understand characteris:cs of par:cipants. 
Eureka 
x 
 
Subjec:ve social status39 
Important social determinant of health. 
Eureka 
x 
 
Income and ﬁnancial security 
Important social determinant of health 
Eureka 
x 
 
Barriers to healthy ea:ng (adapted)  
Directly relevant to eﬀects of interven:on. 
Eureka 
x 
x 
Food security40,41 
Important social determinant of health, directly 
relevant to poten:al eﬀects of FIM programs. 
Eureka 
x 
x 
Mediterranean Ea:ng PaOern 
Assessment (MEPA)42 
Validated measure of diet quality, included in 
Life’s Essen:al 8. 
Eureka 
x 
x 
Quality of Life (EQ-5D-5L) 
Validated quality of life ques:onnaire that can 
be used to support cost eﬀec:veness analysis.43  
Eureka 
x 
x 
General health status 
Measure of general health status. 
Eureka 
x 
x 
 
Cardiac Self-eﬃcacy44 
Important behavioral science construct that may 
be inﬂuenced by the interven:ons. 
EHR 
x 
x 
Pa:ent Health Ques:onnaire – 945 
Validated measure of depressive symptoms 
EHR 
x 
x 
General Anxiety Disorder - 746  
Validated measure of anxiety symptoms 
EHR 
x 
x 
Tobacco use 
Important CV risk factor in Life’s Essen:al 8. 
Eureka 
x 
x 
Sleep hours 
Important CV risk factor in Life’s Essen:al 8. 
Eureka 
x 
x 
Blood pressure 
Important CV risk factor in Life’s Essen:al 8. 
EHR 
x 
x 
Weight/Body Mass Index (BMI) 
Important CV risk factor in Life’s Essen:al 8. 
EHR 
x 
x 
Cholesterol 
Important CV risk factor in Life’s Essen:al 8. 
EHR 
x 
x 
Hemoglobin A1c 
Important CV risk factor in Life’s Essen:al 8. 
EHR 
x 
x 
Self-reported minutes/week of 
moderate to vigorous physical ac:vity  
Important CV risk factor in Life’s Essen:al 8. 
Eureka 
x 
x 
Steps/day 
Objec:ve measure of physical ac:vity in people 
with available data. 
Eureka 
x 
x 
Six-minute walk distance47 
Objec:ve exercise capacity measure collected 
rou:nely as an outcome in CR programs. 
EHR 
x 
x 
Sa:sfac:on with the interven:on(s)48 
Measure of acceptability. 
Eureka 
 
x 
Net promoter score 
Measure of acceptability 
Eureka 
 
x 
Time and costs 
Custom ques:onnaire to help es:mate costs. 
Eureka 
 
x 
Consump:on of food 
Custom ques:onnaire to report consump:on of 
distributed food 
Eureka 
 
x 
Cardiovascular Events 
Events include CV hospitaliza:ons for myocardial 
infarc:on, heart failure, stroke, and deaths. 
EHR 
 
x 
Number of CR sessions aOended 
AOending a greater number of CR sessions is 
associated with greater beneﬁt.49 
EHR 
 
x 
Number of FIM meal units 
Primary outcome of study. We will be able to 
determine this outcome in all par:cipants. 
Because some par:cipants will receive groceries 
and some par:cipants will received meals, we 
will deﬁne this outcome as a meal “unit” 
received from POH. A meal unit is deﬁned as 7 
packaged meals (delivery), 1 grocery box 
(delivery), 1 set (5 or 7) of packaged meals (pick-
up), or 1 grocery distribu:on (pick-up). We will 
collect number of FIM meal units throughout 
par:cipants’ 3-month study par:cipa:on and 
throughout their insurance authoriza:on period. 
POH 
 
x 

 
 
 
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We will also collect number of FIM meal units for 
their dependents, if applicable. 
 
We will conduct op=onal individual semi-structured interviews in a convenience sample of 
study par=cipants and staﬀ with regard to implementa=on of the interven=ons. Par=cipants will 
be asked to provide verbal consent for the interviews. Interviews will be audio-recorded and 
transcribed without reference to the par=cipant iden=fy. 
 
Phase 2 Par8cipant Compensa8on 
Par=cipants will receive $50 for comple=ng eVisit 1 (Month 0) and $50 for comple=ng eVisit 2 
(Month 3) and $50 for comple=ng the op=onal interview. 
Comparators 
Interven;on A: Naviga;on: Naviga=on will occur at both the health system and FIM program 
levels. The health system navigator will be separate personnel from CR program staﬀ to limit 
eﬀects on usual care. Naviga=on will include: mo=va=onal interviewing,24 pa=ent-determined 
visits (i.e., phone, video, or in-person visits depending on pa=ent preference), and delivery of a 
structured approach to par=cipa=on: 1) explain the program, 2) explain the beneﬁts, 3) provide 
posi=ve endorsement, 4) describe process to enroll, 5) welcome ques=ons, 6) address barriers 
to aCendance, and 7) provide with follow-up informa=on.23  Health system naviga=on will 
include at least 3 aCempts to contact par=cipant for each individual session. Par=cipants will 
have 1 weekly naviga=on session un=l the par=cipant enrolls in the FIM program or declines 
further contact. Scripts will be reﬁned based on Phase 1 ac=vi=es. FIM program naviga=on will 
include individual in-person, video, or telephone contacts by FIM staﬀ to par=cipants to address 
par=cipa=on barriers. FIM naviga=on contacts will occur on a weekly basis un=l the par=cipant 
has achieved suﬃcient engagement (receipt of 8 FIM meals) or the par=cipant declines further 
contact. Scripts will be reﬁned based on Phase 1 ac=vi=es. 
 
Interven;on B: Text-messaging: The text-messaging interven=on will be informed by behavioral 
science.32 Text messages will promote healthy ea=ng and par=cipa=on in a FIM program 
through behavior change techniques: provide informa=on about behavior-health link (“Did you 
know that joining a Food is Medicine program like Project Open Hand can lower your chance of 
being hospitalized?), provide instruc=on (“When cooking, use olive oil or canola oil instead of 
buCer”), prompt inten=on forma=on (“Write a list of 3 reasons you want to eat healthy foods, 
and put the list somewhere you will see it ooen”), and provide general encouragement (“Did 
you eat a heart-healthy meal today? )32 The ini=al text messaging library will be adapted from 
messages found acceptable in our previous research. Text messaging will be reﬁned in Aim 1. 
Text messages will be tailored based on a programmed algorithm (e.g., before ini=a=ng the FIM 
program will receive messages about enrolling and aoer ini=a=ng the program will receive 
messages about engagement).  Par=cipants will receive 2-4 text messages per week (frequency 
to be determined in Aim 1)28 un=l the end of the 3-month interven=on or un=l the par=cipant 
opts out of text messages. 
 

 
 
 
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Usual Care: All par=cipants will receive a MyChart message with wriCen instruc=ons about how 
to enroll in a Food is Medicine program. 
Adverse Experience Repor-ng and Documenta-on 
For this minimal risk study, the risks related to par=cipa=on in the research are related to the 
poten=al loss of privacy due to par=cipa=on in research and poten=al discomfort related to 
sensi=ve ques=ons on ques=onnaires. However, we recognize that this popula=on may 
experience adverse events due to their underlying health condi=ons, and that repor=ng of 
these adverse events may be relevant to understanding the eﬀects of the interven=ons and 
Food is Medicine programs more broadly. Thus, we plan to collect data on adverse events as 
part of this study. 
 
Adverse Events 
Following deﬁni=ons from the US Department of Health and Human Services,50 an adverse 
event is any untoward or unfavorable medical occurrence in a human par=cipant, including any 
abnormal sign (for example, abnormal physical exam or laboratory ﬁnding), symptom, or 
disease, temporally associated with the subject’s par=cipa=on in the research, whether or not 
considered related to the subject’s par=cipa=on in the research.  An unexpected AE is deﬁned 
as any adverse event occurring in one or more par=cipants, the nature, severity, or frequency of 
which is not consistent with either: 
1. the known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in (a) the protocol-related documents, such as the IRB-approved 
research protocol and the current IRB-approved informed consent document; or 
2. the expected natural progression of any underlying disease, disorder, or condition of the 
participant experiencing the adverse event and the participant’s predisposing risk factor profile 
for the adverse event. 
Expected adverse events (EAE) are deﬁned as an=cipated events based on the prior experience 
with the assessments and/or interven=on that are listed in the par=cipant consent and 
protocol; these can be aCributed to an underlying health condi=on, the par=cipant popula=on 
being studied, or normal consequences of an interven=on. Within this study, events such as 
sore muscles, minor muscle/ joint pain, fa=gue, sleep disturbance, appe=te disturbance, pain, 
cough, heartburn, cons=pa=on or diarrhea, rashes, nocturia, mood or anxiety, and =nnitus are 
common among older adults with cardiovascular disease who are expected to enroll.  In 
cardiovascular disease pa=ents there are ooen events associated to their health condi=on that 
do not require discon=nuing the study interven=on or components of the interven=on.  
Par=cipants in CR may experience events such as shortness of breath; new pain, pressure or 
aching in chest, arms, jaw, neck, shoulder, or back; fa=gue; light-headedness; irregular heart 
rhythm or heart ﬂuCering; worsening and/or new joint or muscle pain. Par=cipants in this 
research may also experience loss of privacy. 
 
Adverse events will be recorded in the Eureka data collec=on plasorm.  Adverse events will be 
described by dura=on (start and stop dates and =mes), severity, outcome, treatment, and 
rela=on to study interven=on, or if unrelated, the cause. 

 
 
 
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AE Severity 
The guidelines shown in Table 3 below should be used to grade severity.  It should be pointed 
out that the term “severe” is a measure of intensity and that a severe AE is not necessarily 
serious. 
 
Table 3. AE Severity Grading 
Severity  
Descrip;on 
Mild (1) 
Transient or mild discomfort; no limita=on in ac=vity; no 
medical interven=on or therapy required. The subject may be 
aware of the sign or symptom but tolerates it reasonably well. 
Moderate (2) 
Mild to moderate limita=on in ac=vity, no or minimal medical 
interven=on/therapy required. 
Severe (3) 
Marked limita=on in ac=vity, medical interven=on/therapy 
required, hospitaliza=ons possible. 
Life-threatening (4) 
The subject is at risk of death due to the adverse experience as 
it occurred. This does not refer to an experience that 
hypothe=cally might have caused death if it were more severe. 
 
AE Rela8onship to Study Interven8on 
The rela=onship of an AE to the study interven=on should be assessed using the following the 
guidelines in Table 4. 
 
Table 4. AE Rela5onship to Study Interven5on 
Rela;onship 
to Interven;on 
Comment 
Deﬁnitely 
Previously known side eﬀect of interven=on; or an event that follows a 
reasonable temporal sequence from the interven=on; that follows a known 
or expected response paCern to the interven=on; that is conﬁrmed by 
stopping or reducing the interven=on; and that is not explained by any other 
reasonable hypothesis. 
Probably 
An event that follows a reasonable temporal sequence from the interven=on; 
that follows a known or expected response paCern to the interven=on; that 
is conﬁrmed by stopping or reducing the interven=on; and that is unlikely to 
be explained by the known characteris=cs of the par=cipant’s clinical state or 
by other interven=ons. 
Possibly 
An event that follows a reasonable temporal sequence from the interven=on; 
that follows a known or expected response paCern to the interven=on; but 
that could readily have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no rela=onship to 
the study interven=on. 
 

 
 
 
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In accordance with the standard opera=ng procedures and policies of the Ins=tu=onal Review 
Board (IRB)/Independent Ethics CommiCee (IEC), the site inves=gator will report Unexpected 
AEs that are Deﬁnitely, Probably, or Possibly related to study par=cipa=on to the IRB/IEC and 
Principal Inves=gator. 
 
Serious Adverse Experiences (SAE) 
An SAE is deﬁned as any AE occurring that results in any of the following outcomes: 
• 
death 
• 
a life-threatening adverse experience 
• 
inpa=ent hospitaliza=on or prolonga=on of exis=ng hospitaliza=on 
• 
a persistent or signiﬁcant disability/incapacity 
• 
a congenital anomaly/birth defect  
 
Other important medical events may also be considered an SAE when, based on appropriate 
medical judgment, they jeopardize the par=cipant or require interven=on to prevent one of the 
outcomes listed.  
 
Serious Adverse Experience Repor8ng 
We will document all SAEs that occur (whether or not related to study interven=on).  The 
collec=on period for all SAEs will begin aoer informed consent is obtained and end aoer 
procedures for the ﬁnal study visit have been completed. 
 
In accordance with the standard opera=ng procedures and policies of the Ins=tu=onal Review 
Board (IRB)/Independent Ethics CommiCee (IEC), the Principal Inves=gator will report SAEs to 
the IRB/IEC. 
Discon-nua-on and Replacement of Par-cipants 
A par=cipant may be discon=nued from the study at any =me if the par=cipant or the 
Inves=gator feels that it is not in the par=cipant’s best interest to con=nue. The following is a list 
of possible reasons for discon=nua=on: 
• Participant withdrawal of consent 
• Participant does not meet final eligibility confirmation 
• Participant not adherent to study procedures 
• Adverse event occurs that indicates in the opinion of the investigator that it would be in 
the best interest of the participant to discontinue the study 
• Protocol violation requiring discontinuation 
• Lost to follow-up 
• Death 
• Funder or Institution request for early termination of study 

 
 
 
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A par=cipant may be withdrawn from the study at any =me if the par=cipant or the inves=gator 
feels that it is not in their best interest to con=nue.   
 
All par=cipants are free to withdraw from par=cipa=on at any =me, for any reason, speciﬁed or 
unspeciﬁed, and without prejudice. 
 
Reasonable aCempts will be made by the inves=gator to document a reason for par=cipant 
withdrawals.  The reason for the par=cipant’s withdrawal from the study will be speciﬁed in the 
par=cipant’s ﬁle source documents.   
 
Par=cipants who withdraw from the study aoer randomiza=on may not be replaced. 
Protocol Viola-ons 
A protocol viola=on occurs when the par=cipant or inves=gator team fails to adhere to 
signiﬁcant protocol requirements aﬀec=ng the inclusion, exclusion, subject safety and primary 
endpoint criteria.  
  
When a protocol viola=on occurs, it will be discussed with the inves=gator and a Protocol 
Viola=on Form detailing the viola=on will be generated. This form will be signed by the 
Inves=gator. A copy of the form will be ﬁled in the site’s regulatory binder. 
Data Safety Monitoring 
This minimal risk study will not have an external Data Safety Monitoring Board. The Principal 
Inves=gator will monitor study data for completeness and monitor and report adverse events as 
described above. 
Analysis Methods 
Phase 1: We will qualita=vely describe par=cipant responses using rapid template analysis35 
based on the Theory of Planned Behavior36 and emergent themes. At least two study staﬀ 
members will review and code transcripts. Study staﬀ members will meet to achieve consensus, 
with any disputes resolved by the Principal Inves=gator. 
 
Phase 2: Respec=ng sta=s=cal norms for pilot studies, the proposed pilot randomized trial 
mimics the design we hope to use in the future and does not provide p-values or formal sample 
size calcula=ons.51 The pilot study will provide informa=on on the acceptability of the 
interven=ons. The sample size represents 1/3 of CR pa=ents seen at UCSF in 9 months. 
With a sample size of 42 for each experimental condi=on, his pilot study would be able to 
es=mate a mean sa=sfac=on score of 3.5 (scale of 1 to 5, with 5 being very sa=sﬁed) with a 95% 
conﬁdence interval from 3.2-3.8, assuming a standard devia=on of 1. 
This pilot study will address two hypotheses (N=42 each) for the secondary outcome (which we 
expect to be the primary outcome for the future larger study):  
Hypothesis A: Naviga=on + UC (±text messaging) [experimental] will result in a greater mean 
number of FIM meals received in 3 months than UC (± text messaging) [control]. 

 
 
 
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Hypothesis B: Text messaging + UC (±naviga=on) [experimental] will result in a greater mean 
number of FIM meals received in 3 months than UC (± naviga=on) [control]. 
For each interven=on, the null hypothesis is the mean number of FIM meals received will not 
diﬀer between experimental and control groups. Interven=on-speciﬁc analyses will use separate 
generalized es=ma=ng equa=on (GEE) log-Poisson models with robust standard errors to 
es=mate the mean (95%CI) count per group and experimental: control risk ra=o (RR);52 models 
will be adjusted for the opposite experimental arm and baseline 6MWD as a measure of health 
status. An exploratory GEE model adding the A*B interac=on term to models will be conducted 
and displayed in a forest plot of RR (95%CI) of each interven=on arm (n=21) versus UC alone 
(n=21). Log-Poisson models will be used to es=mate mean sa=sfac=on and the propor=ons who 
ini=ated and engaged. We will use standard ANCOVA models to analyze 3-month changes in 
con=nuous outcomes (e.g., self-eﬃcacy) and rank-based ANCOVA for changes in discrete 
outcomes (e.g., Life’s Essen=al 8).53 All ANCOVA models include the baseline value of the 
outcome as a covariate, the opposite experimental arm, and 6MWD. 
 
We will also describe inputs, ac=vi=es, outputs, outcomes using descrip=ve quan=ta=ve 
measures (e.g., counts, propor=on, mean, standard devia=on) and narra=ve descrip=on. We will 
qualita=vely describe par=cipant and staﬀ responses from interviews and study ar=facts using a 
rapid analysis template35 based on the Theory of Planned Behavior,36 Consolidated Framework 
for Implementa=on Research,54 and emergent themes.  
Cost Es-ma-on 
As part of this project, we will es=mate costs of usual care and the interven=ons. 
Usual care (costs may apply to all par=cipants):  
• 
Staff (health system): we will estimate the time it takes for staff to complete the following 
activities: 
o Draft MyChart message 
o Send MyChart message to participant 
o Complete and send referral for to POH 
• 
Staff (POH): we will estimate the time it takes for staff to complete the following activities: 
o Receive and review referral from health system 
o Schedule participant intake 
o Conduct participant intake 
o Engage with participant during the course of the usual care program 
• 
Participant: we will ask participants to estimate time and costs using a custom questionnaire, 
administered at the 3-month eVisit. Time and costs will be related to scheduling POH visits and 
receiving POH meals or groceries. 
• 
POH Supplies, Capital Equipment, Facilities, and Other costs: we will consider POH Supplies, 
Capital Equipment, Facilities, and Other costs on a per participant and/or per meal basis. 
Interven=on A – Naviga=on (costs will only apply to par=cipants randomized to these groups): 
• 
Staff (health system): we will ask staff to record or estimate the time it takes to: 
o Schedule session with participant 
o Prepare for session with participant 
o Engage in session with participant 

 
 
 
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o Complete follow-up tasks from session with participant 
o Hand off to POH 
• 
Staff (POH): we will estimate the time it takes for staff to: 
o Receive hand off from health system 
o Schedule session with participant 
o Prepare for session with participant 
o Engage in session with participant 
o Complete follow-up tasks from session with participant 
• 
Participant: we will estimate participant time from the reported staff time for scheduling and 
engaging with participant. 
• 
Supplies, Capital Equipment, Facilities, and Other costs: we will estimate overhead costs based 
on staff time per participant. 
Interven=on B – Text Messaging (costs will only apply to par=cipants randomized to these 
groups): 
• 
Staff (health system):  
o Time to draft text messages 
o Time to program messages into Eureka 
• 
Cost of delivering messages through Twilio, the service used by Eureka 
• 
Participants will report monthly cost of phone service, include text messaging on the Time and 
Costs questionnaire. 
Data Collec-on, Reten-on, and Monitoring 
Data for Phase 1 will be recorded in study records on UCSF REDCap or UCSF OneDrive. 
 
The primary data collec=on source for Phase 2 will be the Eureka Research Plasorm. This 
plasorm includes par=cipant-facing interfaces for data collec=on, along with inves=gator- and 
clinical research staﬀ-facing interfaces for data entry and management. 
 
Par=cipant data for Phase 2 will also be collected from the UCSF Electronic Health Record and 
entered in the Eureka Research Plasorm. 
 
Data Collec8on Instruments 
The Inves=gator will prepare and maintain adequate and accurate source documents designed 
to record all observa=ons and other per=nent data for each par=cipant.   
 
Where possible, the par=cipant will be asked to supply informa=on regarding par=cipant-
oriented outcomes via par=cipant ques=onnaires in the Eureka Research Plasorm. If 
par=cipants are not able to enter their own responses, study staﬀ may enter par=cipant 
responses through proxy data entry by interviewing the pa=ent in-person or over phone or 
video. 
 

 
 
 
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Study personnel will enter data from source documents corresponding to a par=cipant’s visit or 
par=cipant events into the study Eureka database when the informa=on corresponding to that 
visit or event is available. 
 
The Inves=gator is responsible for all informa=on collected on par=cipants enrolled in this study.  
All data collected during the course of this study must be reviewed and veriﬁed for 
completeness and accuracy by the Inves=gator. 
 
Data Management Procedures 
The data will be entered into the Eureka database.  Database lock will occur once quality 
assurance procedures have been completed. All procedures for the handling and analysis of 
data will be conducted using good sta=s=cal and compu=ng prac=ces.  
 
Data Quality Control and Repor8ng 
Aoer data have been entered into the study database, a system of computerized data valida=on 
checks will be implemented and applied to the database on a regular basis. The study database 
will be updated in accordance with the resolved queries.  All changes to the study database will 
be documented. 
 
Archival of Data 
The database is safeguarded against unauthorized access by established security procedures, 
including two-factor authen=ca=on for inves=gator and study staﬀ access; appropriate backup 
copies of the database and related sooware ﬁles will be maintained.  Databases are backed up 
by the database administrator in conjunc=on with any updates or changes to the database.   
At cri=cal junctures of the protocol (e.g., produc=on of interim reports and ﬁnal reports), data 
for analysis is locked and cleaned per established procedures. 
 
Availability and Reten8on of Inves8ga8onal Records 
The Inves=gator must make study data accessible to authorized representa=ves of the Funder 
(or designee), IRB/IEC, and Regulatory Agency (e.g., FDA) inspectors upon request.  A ﬁle for 
each par=cipant must be maintained that includes the signed Informed Consent, HIPAA 
Authoriza=on and Assent Form and copies of all source documenta=on related to that 
par=cipant.  The Inves=gator must ensure the reliability and availability of source documents 
from which the informa=on in the study database was derived. 
 
All study documents (pa=ent ﬁles, signed informed consent forms, Study File Notebook, etc.) 
must be kept secured for a period of two years following the conclusion of the study. 
 
Monitoring 
Monitoring visits may be conducted by the Funder (or designee), UCSF, or other regulatory 
bodies (e.g., IRB, FDA).   
 

 
 
 
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Par8cipant Conﬁden8ality 
In order to maintain participant confidentiality, all participants will be assigned a unique 
participant number. That number will be used to identify the participant on all study materials. 
 
Data Sharing 
Par=cipant data will be shared with Project Open Hand so that Project Open Hand can provide 
services to the par=cipants. 
 
The UCSF Coordina=ng Center will be responsible for crea=ng analy=c datasets for study 
inves=gators. Data generated within this study will be provided to the American Heart 
Associa=on in a de-iden=ﬁed form, to be deposited within the Health Care x Food data 
repository on the Precision Medicine Plasorm, and subject to the Precision Medicine Plasorm 
Terms and Condi=ons. Data on the Precision Medicine Plasorm will be collated with data from 
other studies that are funded by the American Heart Associa=on Health Care x Food ini=a=ve, 
and used by future inves=gators for analysis. In addi=on, data will be made available on Dryad, 
in alignment with agreed-upon Open Science Policies at the American Heart Associa=on, 
whereby any factual data that is needed for independent veriﬁca=on of research results must 
be made freely and publicly available in an AHA-approved repository as soon as possible, and no 
later than the =me of an associated publica=on or the end of the award period (and any no-cost 
extension), whichever come ﬁrst.   
  
Administra-ve, Ethical, and Regular Considera-ons 
The study will be conducted according to the Declara=on of Helsinki, Protec=on of Human 
Volunteers (21 CFR 50), Ins=tu=onal Review Boards (21 CFR 56), and Obliga=ons of Clinical 
Inves=gators (21 CFR 312). 
 
To maintain conﬁden=ality, all records will be iden=ﬁed by a coded number only.  All study 
records will be kept in a secure electronic ﬁle or locked ﬁle cabinet and code sheets linking a 
pa=ent’s name to a pa=ent iden=ﬁca=on number will be stored separately in another secure 
electronic ﬁle or locked ﬁle cabinet.  Clinical informa=on will not be released without wriCen 
permission of the par=cipant, except as necessary for monitoring by the FDA.  The Inves=gator 
must also comply with all applicable privacy regula=ons (e.g., Health Insurance Portability and 
Accountability Act of 1996, EU Data Protec=on Direc=ve 95/46/EC). 
 
 
Protocol Amendments 
Any amendment to the protocol will be wriCen by the Principal Inves=gator. Protocol 
amendments cannot be implemented without prior wriCen IRB/IEC approval except as 
necessary to eliminate immediate safety hazards to pa=ents.  A protocol amendment intended 
to eliminate an apparent immediate hazard to pa=ents may be implemented immediately, 
provided the IRBs are no=ﬁed within ﬁve working days. 
 

 
 
 
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Ins8tu8onal Review Boards and Independent Ethics CommiMees 
The protocol and consent form will be reviewed and approved by the IRB/IEC prior to study 
ini=a=on.  Serious adverse experiences regardless of causality will be reported to the IRB/IEC in 
accordance with the standard opera=ng procedures and policies of the IRB/IEC, and the 
Inves=gator will keep the IRB/IEC informed as to the progress of the study.  The Inves=gator will 
obtain assurance of IRB/IEC compliance with regula=ons. 
 
Any documents that the IRB/IEC may need to fulﬁll its responsibili=es (such as protocol, 
protocol amendments, Inves=gator’s Brochure, consent forms, informa=on concerning pa=ent 
recruitment, payment or compensa=on procedures, or other per=nent informa=on) will be 
submiCed to the IRB/IEC.  The IRB/IECs wriCen uncondi=onal approval of the study protocol 
and the informed consent form will be in the possession of the Inves=gator before the study is 
ini=ated.  This approval must refer to the study by exact protocol =tle and number and should 
iden=fy the documents reviewed and the date of review. 
 
Protocol and/or informed consent modiﬁca=ons or changes may not be ini=ated without prior 
wriCen IRB/IEC approval except when necessary to eliminate immediate hazards to the pa=ents 
or when the change(s) involves only logis=cal or administra=ve aspects of the study.  Such 
modiﬁca=ons will be submiCed to the IRB/IEC and wriCen veriﬁca=on that the modiﬁca=on was 
submiCed and subsequently approved should be obtained.   
 
The IRB/IEC must be informed of revisions to other documents originally submiCed for review; 
serious and/or unexpected adverse experiences occurring during the study in accordance with 
the standard opera=ng procedures and policies of the IRB; new informa=on that may aﬀect 
adversely the safety of the pa=ents of the conduct of the study; an annual update and/or 
request for re-approval; and when the study has been completed. 
 
Informed Consent  
Informed consent will be obtained in accordance with the Declara=on of Helsinki, ICH GCP, US 
Code of Federal Regula=ons for Protec=on of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, 
and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act (HIPAA, if 
applicable), and local regula=ons. 
 
For Phase 1, we will obtain wriCen informed consent via DocuSign. 
 
For Phase 2, we will obtain eConsent via Eureka. 
 
The Inves=gator will prepare the informed consent form prior to submission to the IRB/IEC.  The 
consent form generated by the Inves=gator must be approved by the IRB/IEC.  The wriCen 
consent document will embody the elements of informed consent as described in the 
Interna=onal Conference on Harmonisa=on and will also comply with local regula=ons. The 
Inves=gator will send an IRB/IEC-approved copy of the Informed Consent Form to the Funder (or 
designee) for the study ﬁle. 

 
 
 
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A properly executed, wriCen, informed consent will be obtained from each par=cipant prior to 
entering the par=cipant into the study.  Informa=on should be given in both oral and wriCen 
form and par=cipants must be given ample opportunity to inquire about details of the study.  If 
appropriate and required by the local IRB/IEC. A copy of the signed consent form (and assent) 
will be given to the par=cipant and the original will be maintained with the par=cipant’s 
records. 
Role of the Sponsor 
This work was supported by the American Heart Associa=on. All statements in this work, 
including its ﬁndings and conclusions, are solely those of the authors and do not necessarily 
represent the views of the American Heart Associa=on. 
 

 
 
 
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References 
1.  
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