My Diabetes, My Community
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: University of Chicago

Official Study Title: My Diabetes, My Community  
IRB number: 20-0870  
NCT Number: NCT04970810  
Final Version Approval date: 11/15/2024  
 
 

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A. Background 
Older African Americans with diabetes are a highly vulnerable population, as tragically 
demonstrated by their disproportionate share of deaths due to COVID-19. In addition to having 
a high susceptibility to external insults, older patients with diabetes suffer from the highest rates 
of cardiovascular and microvascular complications as well as hypoglycemia.1 For many African 
Americans, these risks are compounded by high rates of comorbid illnesses, functional 
impairment, and socioeconomic risks.2  
To address the needs of older patients with diabetes, multiple organizations have called for a 
personalized approach to setting risk factor goals and self-care plans.3,4 The American 
Geriatrics Society (AGS)5 and the American Diabetes Association (ADA)6 have published 
recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, 
or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines 
also acknowledge the importance of addressing individualized socioeconomic risks that are 
barriers to self-care management such as cost-related non-adherence and food insecurity.7 
Despite widespread agreement by experts, the clinical impact of this highly personalized 
approach to diabetes care for older adults has been rarely studied in controlled trials.8 
Interventions designed to personalize diabetes care must overcome multiple challenges to 
implementation including the brief clinical encounter, lack of patient engagement between 
encounters, and lack of systems to leverage community-based self-care resources.     
B. Purpose 
We propose to address these knowledge and care gaps by integrating two evidence-based 
interventions designed to personalize glycemic goals, engage patients and enhance self-care: 
Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and 
CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in 
personalized goal setting and chronic disease management.8,9 The intervention consists of a 
screening survey delivered through the electronic health record (EPIC®) patient portal 
(MyChart®) to assess health status, hypoglycemia risk, barriers to care, and treatment 
preferences. A diabetes nurse then discusses the survey results with the patient to arrive at 
personalized diabetes goals and provides telephonic care management. CommunityRx (CRx) 
is a theory-driven and evidence-based10 community resource referral information system, 
developed and iterated in partnership with stakeholders across health and social care sectors 
and local residents.11,12 During clinical encounters, a printed list of vetted resources (a 
“HealtheRx”) is auto-generated, providing patients with personalized information to address 
basic needs such as food and housing, physical and mental wellness, disease self-management 
and caregiving. In a real-world trial conducted by the PIs, CommunityRx increased knowledge 
about and self-efficacy, or confidence, in finding community resources for self-care.12,13 Based 
on models of shared decision making in minority populations14,15 and the Grey model for self-
care,16 the combination of these scalable interventions would be expected to have additive 
benefits for self-care and clinical outcomes.  
Across the University of Chicago Practice Network, we will conduct a three-arm parallel 
pragmatic randomized controlled trial (1) Attention Control vs. 2) My Diabetes GOAL vs. 3) My 
Diabetes GOAL + CommunityRx) among 505 older, predominantly African American patients. 
We will pilot test the study among 12 additional participants.  During the trial we will address the 
following aims: 
1. Evaluate the impact of My Diabetes GOAL vs. My Diabetes GOAL + CRx vs. Attention 
Control Arm on processes of personalized diabetes care:   

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a. Patients’ experience and satisfaction with goal-setting communication and EHR 
documentation of goals;  
b. Patients’ decisional conflict regarding goals of diabetes care;  
c. Patients’ self-report of diabetes care goals. 
2. Evaluate the impact of My Diabetes GOAL vs. My Diabetes GOAL + CRx vs. Attention control 
on self-care:  
a. Diabetes self-efficacy and self-management behaviors (e.g., physical activity); 
b. Knowledge and utilization of community-based resources. 
3. Evaluate the impact of My Diabetes GOAL vs. My Diabetes GOAL + CRx vs. Attention control 
on clinical outcomes and health care utilization:  
a. Glycemic control and hypoglycemia; 
b. Geriatric syndrome symptom burden (e.g. depression, falls, incontinence); 
d. Functional status; 
e. ED visits and unplanned hospitalizations. 
Personalizing diabetes care in older African American patients with strategies that acknowledge 
personal preference, barriers to self-care and community connections have the potential to 
improve the overall quality of life while minimizing adverse drug events like hypoglycemia. The 
likelihood of sustainability and replicability of My Diabetes GOAL and CRx are high because 
both can be delivered remotely, and both leverage existing clinical staff, electronic health record 
systems, and community resources.17     
C. Methodology 
Potential study subjects will be identified and pre-screened through the electronic medical 
record of the University of Chicago. Physician assent will be obtained to approach a patient. 
Then a research assistant will approach the potential participant to explain the purpose, 
intervention and potential benefits/risks of participating in this study.  All human subjects will be 
consecutively screened for inclusion and enrolled as described in Section P. Recruiting 
Methods.  A research assistant will conduct informed consent with eligible subjects prior to any 
study procedures.  
Electronic Health records will be a critical source of data on key processes of care that are 
affected by My Diabetes GOAL including goal setting measures (documenting personalized 
goals of diabetes care, proportion following ADA recommendations, proportion choosing 
alternative goals) as well as referrals to care management and frequency of phone contacts. 
The EHR will also be the primary source of data for risk factor levels (glycosylated hemoglobin, 
blood pressure, cholesterol levels), medications, and health care utilization (outpatient visits, 
care management services, ER visits, and hospitalizations). These data are continually 
collected as a part of routine care.  If participants receive care outside of the UChicago system 
during the duration of the study and their most recent A1C is not available in the EMR via Care 
Everywhere, we will ask the participant to self-report the A1C and offer the option for them to 
securely upload their results via REDCap survey link to be stored with the rest of their study 
data.  Previously consented subjects that receive care outside of UChicago Medicine will be 
resent the original signed informed consent for review and asked to complete an addendum to 
the consent to include this upload option.  All future subjects will have this upload option 
included in an updated informed consent. We will ask subjects for permission to access their 
medical records for these purposes.   
Subjects will be randomized in a 1:1:1 ratio to the attention control, MDG, or MDG+CRx groups. 
All subjects will be asked to complete surveys upon enrollment, at 6 months, and 12 months.  
This will be a single-blind study, and subjects will be blinded to the different groups. 

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Attention control Arm: These subjects will receive monthly calls with a member of the study 
team. 
My Diabetes GOAL Arm: Subjects will be asked to complete a survey, complete goal setting 
conversation with diabetes nurse, and monthly telephonic care management calls.  Care 
management calls include review of 1) risk assessment and treatment preferences, 2) goal 
setting discussion 3) medication management, and referrals to hospital-based services such as 
diabetes education classes.  
MDG + Community Rx Arm: Subjects will receive the same intervention above as well as 
receive vetted, personalized referrals near the subject’s location to human, social and other 
community-based supports aligned with their diabetes goals and other needs. Beginning with 
the first monthly telephone care management call, the nurse will launch CommunityRx, enroll 
the patient, and utilize NowPow to produce a “prescription” HealtheRx that can be printed, 
delivered by MyChart, text message, and/or or e-mail, according to the patient’s preference. 
This will be repeated at each subsequent monthly call. 
All participants in the study will receive reminders by phone, e-mail, or MyChart message for 
scheduling monthly calls and follow-up surveys. 
 
Participants in all three arms will complete a baseline survey (by phone, video or online) and at 
6 months and 12 months. Please see Table 1 for list of outcomes and corresponding methods 
to obtain the data.  If needed to supplement healthcare utilization data, we will obtain health 
insurance claims for the participant. The informed consent process will inform study participants 
of the rationale for accessing these data and request participants’ permission to do so, if need 
be. 
 
 
Table 1.  Outcomes and Data Collection 
Aim  Outcome 
Source 
Aim 
1 
Shared decision making questionnaire94,95 
Survey 
Decisional Conflict96 
Survey 
Documentation of A1C goal 
EHR 
Patient self-report of A1C goal 
Survey 
Aim 
2 
Diabetes self-efficacy97 
Survey 
Diabetes self-care inventory98  
Survey 
Medication adherence 
Survey 
Dietary adherence 
Survey 
Physical activity adherence 99  
Survey 
Knowledge and utilization of community-based resources12 Survey / NowPow 
Aim 
3 
Glucose control (A1C) 
EHR or Survey 
Hypoglycemia (self-reported)81-83 
Survey 
Hypoglycemia requiring medical assistance 
EHR 
Geriatric syndromes 
Depression100 
Falls101 
Cognitive Impairment102 
Frailty103 
Urine Incontinence104 
Polypharmacy 
Survey and EHR 

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Functional status 
Disability of  (Instrumental) Activities of Daily Living105,106 
Lower Extremity Strength using 5-Repeated Chair 
Stands107 
Gait speed using 8-Foot Usual Walk107  
Survey 
Quality of life (SF-8)108 
Survey 
ED visits and unplanned hospitalizations 
EHR/Medicare claims 
 
Following the trial, we will conduct a brief, qualitative research study. Qualitative data collected 
via focus groups will be used to interpret or triangulate findings from the main trial outcomes 
analysis. Focus group discussions will probe 1) participants’ experiences with the intervention 
and attention control information; 2) participants’ interpretations of preliminary findings, and; 3) 
participants’ thoughts and ideas about opportunities for dissemination of findings to communities 
of interest.   
 
To support Domain 2 of the qualitative protocol (i.e., participants’ interpretations of preliminary 
findings), we will conduct one interim analysis in March 2024 when 100% of participants have 
finished their 6-month survey and about 75% participants will have finished their 12-month 
follow-up survey. The purpose of the interim analysis is to provide findings to share with study 
participants for their feedback and interpretation of mechanisms. We will not change any 
intervention components based on the interim analysis findings. The outcomes studied in the 
interim analysis will be A1C, and self-reported outcome data, including patient self-report of A1C 
goal, Diabetes Self-Care Inventory, medication adherence, knowledge, use of and need for 
community-based resources and hypoglycemia. 
 
D. Duration 
The duration of the protocol is approximately 12 months.  Subjects will be asked to complete 
surveys upon enrollment, at 6 months, and at 12 months.  We anticipate the surveys to take up 
to 25 minutes to complete.  Telephone calls with study team members in all arms should take 
approximately 10-20 minutes to complete. Qualitative focus groups may take 45-60 minutes to 
complete. 
E. Location 
Research under this protocol will be conducted by researchers in the Departments of Internal 
Medicine at the University of Chicago (located at 5841 S. Maryland Ave., Chicago, IL, 60637). 
Additional research (e.g., data preparation and analyses) will be conducted in Dr. Elbert 
Huang’s research offices, located in the Medical Center 2007, Room B214 and Dr. Stacy 
Lindau’s research laboratory, located in the Medical Center 2050, rooms R-311 and R-315. 
The surveys will be conducted via phone, video, or online (Redcap).  Subjects who have 
technical difficulties completing the survey online may ask to meet with the study team in person 
to complete the online survey in person, but with support. Support means helping patients login 
into their MyChart accounts if necessary, supplying a laptop for their use or providing printouts 
or other help needed to complete the surveys. These meetings will only occur at the University 
of Chicago Hospitals, and due to the COVID-19 pandemic, may be conducted via secure ZOOM 
meetings or via telephone. 
F. Special Precautions 

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Protected health information (PHI) will be collected for research purposes and special 
precautions will be made to protect these data. In addition to the unique identifier applied by 
REDCap software, we will use the subject’s name, telephone number and email address to 
facilitate scheduling and completion of the follow-up surveys. We will use the subject’s name 
and medical record number (MRN) to access their electronic medical record to assess their 
eligibility for the study and outcomes data if subjects agree. From EMR data, we will access the 
participant’s health insurance payer and unique beneficiary identification to obtain their health 
insurance claims, if needed. We will compensate participants by gift card, and will use their 
name and address for compensation payment purposes.    
Certain survey data elements collected in the REDCap database will be sent securely to 
NowPow, a systematic resource referral platform, to generate the HealtheRx. Elements of 
PHI sent to NowPow to generate a personalized HealtheRx include: participant name, 
participant home address, date of birth and other non-PHI data elements. Data will be 
securely transferred from REDCap to NowPow through a custom secure integration created 
by the Center for Research Informatics. In addition to other non-PHI data elements, 
respondent address is necessary to better tailor the community resource information 
provided on the personalized HealtheRx.  
 
Metadata generated by use of the NowPow system will be provided to the research team via 
Globus (https://rcc.uchicago.edu/documentation/_build/html/data-transfer/index.html#globus-
online) on a regular basis (see documentation below). NowPow is a company serving dozens 
of blue chip health systems using rigorous data protocols and therefore operates its 
technology in a manner that meets the strict HIPAA and security criteria standards of these 
organizations.  
 
Qualitative interviews will be audio recorded and transcribed using AWS Transcribe by Amazon. 
AWS Transcribe has been reviewed by the University of Chicago Biological Sciences Division’s 
Information Security Office and approved for this use. Interviews will be de-identified upon 
transcription. 
 
 
Because PHI will be accessed and collected for this program of research, there is a risk of loss 
of confidentiality. To protect confidentiality, we will implement a plan to protect data in all its 
forms from improper use and disclosure using HIPAA compliant policies and procedures; see 
Section N. Procedures to Maintain Confidentiality for more information.  
Use of Globus for file transfer  
A Globus endpoint will be created by the Biological Sciences Division’s Information Services 
pointing to the lindau-lab file share on PRFS. The endpoint will be configured to force encryption 
of the data channel. A dedicated subdirectory within the file share will be created, and a guest 
collection will be created permitting authorized users to access that subdirectory. NowPow will 
be granted access to that collection, and will use Globus (either the client or API) to transfer files 
into the dedicated subdirectory where they may be retrieved by an analyst in the Lindau Lab.  
G. Experimental controls and use of placebos  
Participants in this study will be enrolled in attention control, the MDG intervention, or MDG + 
CRx intervention.   

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Usual care for diabetes at the University of Chicago is constantly evolving and has features that 
are important to describe and acknowledge. Since 2018, Dr. Huang has been co-chair for 
diabetes quality improvement at University of Chicago Medicine. University of Chicago has high 
rates of poor diabetes control based on the quality measure of A1C>9.0%. To reduce rates of 
poor control, the ambulatory quality improvement team has: 1) conducted system wide outreach 
to patients to get an A1C test, 2) installed Best Practice Alerts to remind physicians to order lab 
tests for diabetes, 3) installed point of care testing to primary care clinics, 4) created new drug 
prescribing SmartSet modules, and 5) organized and vetted patient education materials. 
University of Chicago also has diabetes education programs, a specialized pharmacist 
designated to solve problems with high drug prices. This collection of interventions has been 
associated with steady decline in the rates of poor control (29.2% in April 2019 to 26.6% in 
March of 2020).  
To reduce the chance that benefits from the My Diabetes GOAL arms are due to attention 
alone, we will also conduct monthly calls to attention control subjects but will not discuss 
specific issues related to diabetes care. These calls will also help to ensure retention of 
attention control subjects in the study. 
To reduce bias, we will blind participants to the arm of the intervention at the time of enrollment.   
 
H. Type and number of experimental subjects 
Individuals will be contacted for enrollment using methods described below in Section P. 
Recruiting Methods. Individuals will be contacted, screened for inclusion, recruited for study 
participation and participate in the informed consent process. We plan to enroll up 517 patients 
(12 in the pilot, 505 in the RCT). We will determine trial arm assignment through a random 
number generator. Patients will be blinded to study hypotheses and will be unaware of 
allocation.  Our data analyst will be blinded to the treatment allocation of patients. 
Inclusion Criteria: 
- Males and females 60 years of age or older 
- A1C 7.5% or greater 
- Clinical encounter at UChicago practice in prior year 
- Have access to a cell phone and provides the research interviewer with the cell phone number 
with internet access OR have a personal email address. 
 
Exclusion Criteria: 
- Patients unable to provide consent for themselves (specifically with a diagnosis of Alzheimer's 
disease and related dementias) and complete outcome assessments 
- Terminal illness 
- Living in an institutional setting (non-community dwelling) 
- Unable to read, write, or speak English or Spanish 
- Recent enrollment in My Diabetes GOAL or Community Rx Trials 
 
 
I. Statistical analysis 
An intention-to-treat analysis principle will be applied to all patients’ outcomes, regardless of 
ineligibility and actual intervention provided. Multiple imputation will be used to impute missing 

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values for those data missing at random.112 We will conduct analyses using observed data as 
main analyses and imputed data as part of sensitivity analyses.  
Aim 1: To compare continuous outcomes such as the decisional conflict score, we will use a 
linear mixed model (LMM) over the three study groups. To compare processes that are binary 
(e.g., patients self-reporting a goal) at 12 months, a chi-squared test and a logistic regression 
model will be used and the latter method will adjust for patients’ potential confounders such as 
age, gender, race, health status, and duration of diabetes. In addition, we will use the 
generalized estimating equations (GEE) and generalized linear mixed model (GLMM) (which 
may be computationally intensive) to model proportion of patients with documented goal over 
time (baseline and 12 months) and test the effects of treatment, time, and interaction between 
treatment and time. 
Aims 2 and 3: To compare self-care continuous outcomes and clinical continuous outcomes 
including A1C (primary outcome) over the three study groups, a repeated measure analysis of 
variance via LMM will be performed to model one outcome over time and test the effects of 
treatment, time and their interaction. Clinic will be considered as random effects in a LMM to 
account for within-site association. We will fit an unadjusted model first and then an adjusted 
model adjusting for baseline outcome and participant-level potential confounders as mentioned 
above. Normality will be checked and appropriate data transformation will be performed if data 
highly skewed. The p-value for the group comparison between MDG and MDG+CRx in A1C at 
12 months will be used for the primary objective analysis at the two-sided significance level of 
5% (consistent to the power justification (below)). Multiple pairwise comparisons will be 
conducted to compare between groups at each time point and compare the multiple time points 
within a group. All the multiple comparisons and analyses of all the secondary outcomes will be 
considered to be exploratory and will not spend the overall type I error rate of 5%. To compare 
each of binary outcomes such as utilization of community-based resources, we will use GEE 
and GLMM for group comparisons, as mentioned in analyses of Aim 1. To compare health care 
use (ED and hospitalizations), we will use both Poisson and negative binomial regression 
models. If the health care use data are zero-inflated (i.e., >50% of patients who have no service 
use), we will use both zero-inflated Poisson and zero-inflated negative binomial models. 
Sensitivity analyses: We will also assess the impact of our interventions across patient 
subgroups (age group, health status, baseline A1C group, and diabetes duration with different 
thresholds). 
 
Interim analyses: We will apply the statistical methods above to all the available data including 
baseline, all 6-month follow-up data, and about 75% 12-month follow-up data.  
Qualitative interview data will be systematically collected and analyzed using rapid qualitative 
methods.117 Rapid qualitative methods are well-suited for mixed methods studies and commonly 
used in implementation science studies when quick understanding of qualitative data is needed 
to inform next steps or to help interpret or triangulate findings. Rapid qualitative methods use 
constant comparison of data to inform continued data collection, and analysis is conducted 
during data collection through the use of text summaries.  
Focus groups will be audio-recorded to ensure the accuracy of participants’ responses. 
Researchers will create a data analysis template that includes a neutral domain name that 
corresponds with each focus group question. Trained researchers will listen to the audio of each 
focus group session and create a summary of each domain, with space for other observations 
that may occur during data collection. Then, all text summaries will be collated into one matrix 
(focus group x domain) and assessed for similarities and differences across responses and by 

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domain. Matrices may also be set up by individual focus group or by respondent study arm 
(e.g., pooling all responses for those who participated in the intervention group), if appropriate. 
Matrices will be analyzed for gaps in the data, emergent themes and to generate summaries of 
responses from participants in each study arm.  
Addition of a Usual Care Arm 
To assess whether the experience of the participants within the trial differs from patients at UCM 
who did not participate in the trial during the study timeframe, we will include a Usual Care Arm 
based on the original eligibility criteria used to generate the ACRES recruitment lists of patients 
and include retrospective outcomes data (A1C and medications between 9-23-2020 to 9-16-
2024).  
Among the 167 patients who were enrolled in attention control arm, 133 patients had an A1C 
result in EHR at 12 month follow up by May of 2024. These patients had an average reduction 
of 0.97% (SD 1.64%) in A1C from baseline to 12 month. Based on our literature review, we 
found no consistent pattern for A1C change in usual care arms in behavioral intervention trials 
published in 2023 and 2024.118-129 Based on this finding, we assume no A1C change will be 
observed in our usual care arm. By a two-sample t-test, a sample size of 39 in the usual care 
arm would guarantee ≥ 90% power to detect at least 0.97% difference in A1C with the common 
SD of 1.64% between the attention control arm and usual care arm with a two-sided significant 
level of 5%. To account for up to 20% of subject attrition at 12 months, the final total sample 
size of the usual care arm is 49.  
For simplicity, we plan to conduct a 1:1 matching for the usual care arm vs attention control arm 
(i.e., 167 patients will be included in the usual care arm). The matching procedure involves three 
steps. First, we identify all the potential usual care arm patients using the original eligibility 
criteria and have CRI generate a deidentified (except month and year of dates) list of patients at 
UCM excluding those who were enrolled in the study and ages over 89. Second, we will only 
include patients who have an A1C >= 7.5% within our trial recruitment time (09-23-2021 to 07-
07-2023). Third, we use R MatchIt package to perform the matching. We use exact matching on 
A1C group (7.5-8, 8-8.5, 8.5-9.5, 9.5+) and the calendar quarter using month and year when the 
A1C test was conducted. This step ensures patients who are enrolled in the usual care arm 
have similar A1C values and baseline dates as the attention control arm. We will also use 
propensity score matching on other covariates, such as age, gender, race/ethnicity. After the 
matching, we test the balance of the data on these covariates.  
 
J. Potential risks and benefits 
This program of research involves no more than minimal risk or no more risk than is 
encountered in routine medical and psychological examinations. The risks of participation in this 
protocol include a potential loss of confidentiality or psychological or emotional discomfort 
associated with the interview questions. Every effort will be made to ensure subject 
confidentiality and that risks due to loss of confidentiality are minimal compared to the protocols 
in place to protect human subjects’ data. To date, more than 113,000 individuals have 
participated in CommunityRx intervention studies with no known adverse events or breaches of 
confidentiality. All data collected from human subjects will be collected using standard survey 
procedures. The surveys will be conducted via telephone or online. Psychological and/or 
emotional discomfort associated with the survey questions is possible. Subjects will be informed 
that they can decline to answer any question and can terminate the survey at any time. 
Explanatory statements will be included in the surveys to help the interviewer monitor and 
respond appropriately to discomfort, including termination of the survey if necessary. 

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Alternatives to participation include not participating in the research; participation is completely 
voluntary. Additional protections against these risks are described in Sections M and N, 
Informed Consent and Confidentiality, respectively. 
 
There is no direct benefit to human subjects involved in the research beyond the information 
provided during attention control and the My Diabetes Goal and CommunityRx interventions. 
However, subjects may see an improvement in their health through additional screening for 
risks associated with their chronic disease, improved communication with their physician, 
referrals to beneficial resources that they may not be aware of, which could improve patient 
outcomes.  
 
Risks include a breach of confidentiality and psychological or emotional discomfort associated 
with the interview questions; both minimal and reasonable in relation to the anticipated benefits 
to research participants and people with Diabetes.  
 
K. Monitoring of safety 
The proposed data collection presents no more than minimal risk or no more risk than is 
encountered in routine medical or psychological examinations. As described, no surveys will be 
conducted without explicit documentation of informed consent and individuals will be provided 
with appropriate information about confidentiality when enrolling in the study and will indicate 
acceptance of these risks upon consent. Because we are not proposing a multi-site clinical trial, 
a Phase III trial, or a drug study, this study will not employ a Data and Safety Monitoring Board. 
Procedures are in place to ensure confidentiality and provide full informed consent as discussed 
below. 
The research team has listed the Principal Investigators and study coordinator phone numbers 
on all study correspondence and forms. The purpose of the phone numbers is to provide 
respondents with a number to call if they have questions about any aspect of the study. 
The subjects will be monitored via their survey responses and screened for any potential risks 
for harm. If the research study diabetes care manager conducts telephonic care management 
with patients, they will also be monitored for safety by a registered nurse as the diabetes care 
manager is a registered nurse.   
Research staff will strictly adhere to the procedures for enrolling participants and collecting data 
as outlined by the investigators. At the conclusion of the study, all hard copy materials, with the 
exception of the consent copies, will be destroyed and electronic files will be deleted or archived 
in password-protected files. Informed consent documents (paper or electronic) will be stored for 
at least 6 years following the completion of the study (defined by the last publication related to 
the study). Due to the small sample sizes associated with the pretest, these data will not be 
made publicly available. 
We will review the contents of the informed consent document together with patients, and ask 
follow up questions about the study. We will make sure to let patients know they can ask 
questions they may have, and that they understand that participation in the study is completely 
voluntary. 
Also, because the baseline survey is interviewer-administered, the research assistants will 
continue to query whether or not the subject continues to understand their participation 
throughout the study. Subjects can refuse to answer any question or decline to participate at 
any time. 

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If they opt to participate and complete the survey, we will continue to check-in with them and 
ask follow up questions about their participation in the study. We will withdraw them from the 
study if requested at any time, and ensure that they understand what the purpose of the study 
is. 
We have listed the Principal Investigators' and study coordinator phone numbers on all study 
correspondence and forms. The purpose of the phone numbers is to provide respondents with a 
number to call if they have questions about any aspect of the study. If concerns regarding a 
participant’s safety are endorsed within the health-related social needs screening, REDCap will 
deliver an alert to the research assistant (RA) after survey completion that the participant 
screened positive for safety concerns, without revealing the survey contents.  The respondent 
will receive the contact information for the 24/7 domestic abuse hotline. During the study, should 
a subject express intent to harm themselves or others, we will contact a health or public safety 
professional. We will give only the subject’s name, contact information, and why we feel he or 
she is at risk of harming themselves or others. This report will not be linked to their survey 
information. Subjects have the right to refuse to speak to the mental health professional. If the 
survey procedure results in the observation or suspicion of elder or child abuse, all research 
personnel will act in compliance with Illinois State law in regards to mandatory reporting of 
abuse. 
L. Payment 
All subjects enrolled in the trial will be paid for completing each survey. Subjects enrolled in the 
study will receive a $25 gift card by mail in compensation for completion of the baseline survey 
(approximately 25 minutes).  They will receive $50 in compensation after the completion of the 6 
month survey. They will finally receive $75 after completing the 12 month survey. Subjects may 
receive up to $150 total for completing the study. Compensation will not be prorated for partial 
completion of surveys but every effort will be made to allow for ample time to complete the 
surveys and participants can refuse to answer any question they do not want to answer. 
Participation is voluntary.  
Subjects will be entered into a raffle to win a $50 gift card if they participate in 4 monthly phone 
calls (up to 3 times in the study period). Each verification (one at 4-months, one at 8-months, 
and one at 12-months) counts as one raffle entry. Within 3 months of each verification, they will 
receive an email notification about whether they are the raffle winner. If they’re the winner, they 
will receive their compensation by mail within 4 weeks of e-mail notification. 
Subjects who complete the qualitative focus group will receive a $50 Amazon or Target gift card 
by mail upon completion of the focus group. 
M. Informed Consent 
The research team will obtain informed consent from all subjects and will use paper or an e-
consent process developed in partnership with REDCap and used previously by our research 
team.   
 
We will call patients and ask them if they would be interested in participating in the study.  If 
they are interested, subjects will have the option to have the consent e-mailed, faxed, or mailed 
to them for review. Subjects may also have the option of e-signing the consent in a form in 
REDCap, or meeting a member of the study team to sign the consent in person. Once received, 
we will review the document together and if the patient consents to participate, they will sign the 

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document and either fax or email a scanned copy of the consent back to the research office, or 
mail it back to the study research office.   
 
Research interviewers will guide subjects through the informed consent document, providing 
statements to address: that the study involves research; the study’s purpose, duration, 
procedures followed, risks and benefits, alternatives to participation, and confidentiality of 
records; to whom they should direct questions or contact in case of research-related injury; and 
statements regarding voluntary participation, refusal to participate, and discontinuation of 
participation. The researcher will provide adequate time for the potential subject to ask 
questions and will answer these questions before requesting their signature to document 
consent. The researcher will walk the subject through the consent process via phone or video 
and, if they choose to participate, they will electronically sign the consent form in REDCap by 
typing their full name into the signature field and verifying their identity by entering their date of 
birth. A copy of the signed consent form will be shared with them via e-mail.   
We are requesting a waiver of documentation of consent for participation in the qualitative 
interviews/focus groups, and will obtain verbal consent immediately before data collection. 
Similar to the process for consent for participation in the RCT, researchers will guide 
participants through an informed consent script and ask for their verbal consent before 
proceeding with the interview. A copy of the informed consent script will be emailed to the 
participants for their records. The informed consent document is enclosed in this submission for 
review.  
No surveys or interviews with human subjects will be conducted without explicit documentation 
of the informed consent process executed with each participant. Paper consent forms will be 
printed in large font and written in easily understandable language. Paper consent forms will be 
printed in duplicate, with a copy each going to the respondent and to the Huang and Lindau 
Laboratory receipt control. Paper forms will be kept secure in locked cabinets in locked rooms. 
Consent documents will be received at the Huang and Lindau Laboratory by Ms. Nathan, Senior 
Research Project Manager, to confirm participation in the study for data collection, validation, 
and data analysis purposes.  
 
N. Confidentiality 
 
The proposed research with human subjects, presents no more than minimal risk or no more 
risk than is encountered in routine psychological examinations. Any potential risks may be due 
to emotional or psychological discomfort associated with the surveys or a breach of 
confidentiality. As described in detail above, no surveys will be completed without explicit 
documentation of informed consent and written authorization for the use and disclosure of 
identifiable data will be sought and obtained for all subjects enrolled in this study. All individuals 
will be provided appropriate information about privacy and confidentiality when enrolling in the 
study and will indicate acceptance of these risks upon consent/authorization.  
 
The research team has strict and secure procedures for protecting against and minimizing 
potential risks to human subjects’ data. All survey data will be entered directly into REDCap, a 
password-protected database managed by the Center for Research Informatics (CRI) at the 
University of Chicago (cri.uchicago.edu). CRI provides a HIPAA-compliant data storage and 
computing environment that has achieved security accreditation by the Biological Sciences 
Division’s Risk Management Group. Data will be saved to the secure servers at the University of 
Chicago via a secure wireless connection on a secure, password-protected tablet, or research 

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staff will enter REDCap data directly on departmental computers using the secure, password-
protected network. Data are backed up at the end of each collection day. Data will never be 
stored locally. 
We will use Mosio, a text messaging platform, to facilitate the text message protocol for human 
subjects in the intervention group and manage survey scheduling and reminders for all 
participants. To this end, REDCap will retain certain data elements to Mosio via REDCap’s 
secure API. Mosio provides a secure messaging and data storage environment and has been 
approved for use by the University of Chicago Information Security Office. Only approved 
researchers on the study team will have access to data stored by Mosio and will have the ability 
to securely download data directly to password-protected computers. 
REDCap will integrate electronically with NowPow (www.nowpow.com) to facilitate generation of 
the HealtheRx. Data will be pushed from REDCap to NowPow via a custom secure integration 
to create the participant’s profile in NowPow, including name, address, date of birth and other 
non-PHI data. Any data sent to NowPow from REDCap to generate the personalized HealtheRx 
will be assigned a secondary unique ID in order to prevent any connection to the subjects’ 
responses in REDCap. NowPow is seamless, secure and HIPAA-compliant. Data are backed 
up automatically and encrypted in-transit, at-rest, and end-to-end. De-identified metadata will be 
transferred to researchers in the Lindau Laboratory using the Globus system; details described 
above. All devices used by researchers to collect or access research files will be encrypted. 
Only approved research analysts will have access to files that link participant’s PHI to their 
unique identifiers for the purposes of creating analytic datasets. 
 
REDCap will integrate electronically with the Mosio texting platform (www.mosio.com) to 
facilitate the text message protocol for human subjects in the intervention group and manage 
survey scheduling and reminders for all participants. To this end, REDCap will push the 
subject’s name, telephone number and date of enrollment to Mosio via REDCap’s secure API. 
Mosio provides a secure messaging and data storage environment and has been approved for 
use by the University of Chicago Information Security Office. Only approved researchers on the 
study team will have access to data stored by Mosio and will have the ability to securely 
download data directly to computers within the UCM network. 
 
All hard copies of project materials will be stored in locked file cabinets in locked offices at 
University of Chicago. Laptop computers used to collect data will be encrypted and password 
protected. All data transmitted to secure servers will be encrypted. Analytic files will either be 
de-identified prior to analysis or limited to the minimum amount of data necessary to accomplish 
the intended research purposes per the HIPAA Privacy Rule. Any analytic datasets will limit the 
use or disclosure of PHI to the minimum necessary, if any at all, to accomplish the intended 
research purposes. Only IRB-approved researchers on this protocol will have access to data. 
These controls meet or exceed the strictness of practices legislated and enforced by the 
University of Chicago Biological Sciences Division and hospitals for protected health 
information. 
 
Procedures are in place to ensure confidentiality and provide informed consent as discussed 
above. Numeric coding of surveys/interviews and secure containment of files that link 
participant’s responses from PHI will also minimize this risk. Finally, the research team will 
provide a contact phone number that will be included on all study correspondence and forms. 
The purpose of this phone number is to provide respondents with a single number to call if they 
have questions about any aspect of the study. 
 

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O. Bibliography (please refer to the end of the document) 
 
P. Recruiting methods 
Given the shift to telehealth appointments at UCM and shelter-in-place orders due to the 
COVID-19 pandemic, we are planning to conduct this study completely remotely. We will also 
work with CRI to create an ACRES Report to obtain a list of eligible patients.  Researchers will 
contact patients by phone and explain that patients may be eligible for a research study and 
screen patients for eligibility if the patient is interested. If the patient is eligible, researchers will 
send them an e-consent form using REDCap that is able to be filled out online or other methods 
described earlier. The e-consent process is one that has been developed successfully in our 
lab.  
Dr. Elbert Huang and Dr. Stacy Lindau lead the My Diabetes, My Community trial - a three-arm 
parallel pragmatic randomized controlled trial among older, predominantly African American 
patients with type 2 diabetes seen at the University of Chicago. A dementia diagnosis and 
inability to complete the study on their own are two of the exclusion criteria for the trial. During 
screening, it is possible for research assistants to contact patients living with dementia or their 
caregivers. When a patient with dementia and their caregiver are identified and screen out in the 
MDMC trial, there is an opportunity to ask whether they would be interested in participating in 
another trial they may be eligible for - the CommunityRx-Caregiver trial. The MDMC research 
assistant would ask if the patient is interested in hearing more about a trial they may be eligible 
for and whether it is ok to share their phone number with the CommunityRx-Caregiver team. In 
receiving verbal consent to share their phone number with the CommunityRx-Caregiver team, 
the MDMC research assistant will document this in the patients’ screening data in REDCap and 
notify the MDMC Project Manager (PM). The MDMC PM will then flag this record to the 
CommunityRx-Caregiver PM. Jyotsna Jagai, who is also on the MDMC staff. A CommunityRx-
Caregiver team member will then follow-up with the patient about participating in the 
CommunityRx-Caregiver study. 
If we are able to safely approach patients in-person again, as we have done in prior trials in this 
setting, we will review the informed consent and study procedures with them.  
In addition to recruiting via ACRES reports and CRI data mart, we will use the ITMs research 
profile website, https://bethenewnormal.org/, and researchmatch.org to post our study and to 
use it as a recruiting tool for eligible subjects.   
Once their participation in the RCT is complete, a purposeful sample of participants will be 
approached for inclusion in a focus group. Researchers will contact participants by email, text 
message and phone. In order to appropriately capture data relative to each study arm, we will 
purposefully recruit participants based on study arm.  
Research interviewers will explain that the participant may be eligible for a research study and, 
if interested, further screen for eligibility. Recruitment scripts for the various modes of contact 
have been submitted for review with this protocol. If eligible, researchers will guide participants 
through the informed consent process as described in Section M. Informed Consent.   
Q. Notification of physician 
Notification of the subject’s treating physician for permission to enroll will occur using a multi-
pronged approach. First, we will educate all treating physicians and residents working in the 
target clinics about the study prior to study enrollment and give treating physicians (along with 
their patients) the opportunity to opt out of study participation. Secondly, we will use these 

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education sessions to identify how treating physicians wish to be contacted for permission (e.g., 
via text, email, phone, text page or through the electronic medical record system). We will use 
that communication as documentation of treating physician permission.  
R. Anticipated coordination 
Inter-departmental faculty coordination will be facilitated by regular research meetings attended 
by Drs. and Huang (PIs) and other Co-Investigators and key personnel. Faculty will also 
regularly communicate by email and phone calls as necessary. Co-Principal Investigator Dr. 
Elbert Huang (Professor of Medicine) will oversee enrollment of subjects in the Primary Care 
Clinic and the University of Chicago PBRN Clinics (https://pbrn.uchicago.edu/). 
S. Pregnancy test 
Not applicable. 
T. Exclusion of women, minorities and/or children 
This study will not exclude women, minorities or children.  
U. Drugs 
No drugs will be given to subjects as part of this study.  
 
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