Combining Best Practices for Health Behavior Change: a Randomized Controlled Trial of Digital Health, Financial Incentives and Community Health Worker Support for Vulnerable Populations
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: University of Pennsylvania

 
 
 
 
Using Digital Health, Financial Incentives, and Community Health Worker Support to Change 
Health Behavior 
 
Study Protocol and Statistical Analysis Plan 
 
NCT03939793 
 
June 22, 2020 

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Protocol Details
Basic Info
Conﬁrmation Number:
dbhdjigf
Protocol Number:
832886
Created By:
HARTE, RORY
Principal Investigator:
KANGOVI, SHREYA
Protocol Title:
DFI CHW Engage Study
Short Title:
Engage Study
Protocol Description:
To test a hybrid intervention consisting of a digital health intervention coupled with ﬁnancial 
incentives (DFI) combined with community health worker (CHW) support. The target population 
is low-income people with diabetes. Participants will be randomized to one of three arms: 1) DFI 
intervention, 2) hybrid DFI/CHW intervention, 3) usual care.
Submission Type:
Biomedical Research
Application Type:
EXPEDITED Category 6, Category 7 and Category 2
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
KANGOVI, SHREYA
Dept / School / Div:
2100 - Health System
Campus Address
Mail Code
6021
Address:
423 Guardian Drive
1233 Blockley Hall
City State Zip:
Philadelphia PA 19104-6021
Phone:
215-573-0295
Fax:
215-573-8779
Pager:
Email:
shreya.kangovi@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed :

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Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania? Please refer to the Patent and Tangible 
Research Property Policies and Procedures.
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
The following documents are currently attached to this item:
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Biomedical Research
Clinical Trial*
Is this a clinical trial? Please note the following deﬁnition:Clinical trial is deﬁned as a research study in 
which one or more human subjects are prospectively assigned to one or more interventions (which may 
include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral 
health-related outcomes. See CFR 45.46.102(b)
Yes
If Yes, please be aware that for each clinical trial conducted or supported by a Federal department or 
agency, one IRB-approved informed consent form used to enroll subjects must be posted by the 
awardee or the Federal department or agency component conducting the trial on a publicly available 
Federal Web site that will be established as a repository for such informed consent forms. For more 
guidance, please see: https://irb.upenn.edu/homepage/how-to-submit/initial-submission/2018-common-
rule.  Please see: https://irb.upenn.edu/clinicaltrials for additional clinical trial requirements.
Investigator Initiated Trial*
Is this an investigator initiated trial? Please select "Yes" if ALL the following conditions are met:The 
research is subject to FDA regulations for human subjects research.The individual PI both initiates 
(plans and designs) and conducts an investigation and under whose immediate direction the 
investigational agent is administered or dispensed. The individual investigator has absolute 
responsibility and accountability and designs, conducts, monitors, manages the data, prepares reports 
and oversees all regulatory and ethical matters. See 21 CFR 312.3
No
Drugs or Devices*
Does this research study involve Drugs or Devices?
No
IND Exemption
For studies that fall under an IND exemption, please provide the number below
For studies including IND or IDE's, please provide the number(s) below
IDE Review*
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https://
www.med.upenn.edu/pennmanual/secure/investigational-product-management-at-sites-not-using-
investigational-drug-services-(ids).html Please check the box Yes if you have reviewed the guidance.
No
Research Device Management*
Please indicate how research device(s) will be managed.
Not Applicable (no investigational devices)
Drug, Herbal Product or Other Chemical Element Management *
Please indicate how drugs, herbal products or other chemical entities will be managed.
Not Applicable (no drugs, herbal products or other chemical entities)
Radiation Exposure*
Are research subjects receiving any radiation exposure solely because they are enrolled in this protocol? 
(e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, FDG, Tc-99m, etc.)?IF YES, the protocol must be 
approved by the RRSC (Radiation Research Safety Committee). Consult EHRS web site: 
www.ehrs.upenn.edu/protocols/radiohuman.html for more information.If you have questions, email 
jjesik@ehrs.upenn.edu or kavyap@upenn.eduIf your protocol includes Nuclear Medicine Procedures, 
the protocol must be reviewed by the Nuclear Med Operations Committee: https://redcap.link/NMOPS
No

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Gene Transfer*
Does this research involve gene transfer (including all vectors) to human subjects? IF YES, the protocol 
must be approved by the Institutional Biosafety Committee. Consult EHRS web site: 
www.ehrs.upenn.edu/protocols/bio_humans.html for submission requirements If you have questions, 
call 215-898-4453. The protocol may also require review by the Senior Vice Provost for Research's 
Human Research Advisory Committee(HRAC). The IRB will notify the PI and study staff if this review 
is warranted. 
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)? IF YES, consult the EHRS web site: www.ehrs.upenn.edu/programs/
bio/bbpathogens.html for information on OSHA Bloodborne Pathogens requirements (training, 
vaccination, work practices and Exposure Control Plan). If you have questions, call 215-898-4453. 
Yes
Image Guided Biopsies*
Does the research involve imaging guided biopsy? IF YES, please contact the Clinical Imaging Core. 
See https://www.med.upenn.edu/cbi for more details. Any questions should be directed to the Director 
of Research Operations, Dept of Radiology, Kathleen Thomas. 
No
Computerized Tomography (CT) Studies*
Does the protocol involve CT scans that are not considered standard of care and are being performed for 
research purposes?IF YES, complete the CACTIS Committee Application: https://is.gd/CACTIS and 
consult CACTIS website: http://www.uphs.upenn.edu/radiology/research/labs/cactis/ for application 
requirements.
No
CAMRIS and MRI Studies*
Is an MRI scan being performed for research only and NOT considered standard of care (example: 
speciﬁc scanner, parameters or solely for the purposes of research)?NOTE: Research/non-standard use 
of MRI may include but is not limited to any of the following: Situations in which MRI results may 
impact subjects current clinical care plan or treatment decisions, such as:The study requires a 
customized report with speciﬁcs regarding the study protocol (i.e., speciﬁc measurements or details); 
Introduction of a device of any kind during the MRI that is not used during a 'standard of care' type 
scan.Your MRI is not consistent with standard care time points for MRI imaging.Your MRI is not paid 
for by insurance.IF YES, consult CAMRIS website: https://www.med.upenn.edu/camris/application-
and-faq.html for application requirements and required institutional consent form language.
No
Investigational Agent or Device within the Operating Room*
Does the research project involve the use of an investigational agent or device within the Operating 
Room?
No
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories? Therapeutic, 
Prevention, Supportive Care, Screening, Early Detection, or Diagnostic, Epidemiologic, Observational, 
Outcome, Ancillary or Correlative. For a description of these categories, see http://www.ctsrmc.org/
submitting_a_protocol.php NCI Cooperative Groups are as follows:Alliance for Clinical Trials in 
OncologyNCI Clinical Trials Group (Canadian Cancer Society) (NCCTG)Children's Oncology Group 
(COG)NRG Oncology GroupECOG-ACRIN Cancer Research GroupSouthwest Oncology Group 
(SWOG) IF YES, the protocol must be submitted to the Cancer Center's Clinical Trials Scientiﬁc 
Review Committee for scientiﬁc review and approval prior to obtaining IRB approval. Consult the 
CTSRMC website: www.ctsrmc.org for application requirements 
No
Processing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No

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In-House Manufacturing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
Yes
Indicate which item is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
Cohort/data analysis tools used
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
CHPS Resources*
Does the research involve CHPS resources?
No
HUP Inpatient Nursing Resources
Does this research include an inpatient admission at HUP?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
Yes
Clinical Laboratory Services*
Will samples be collected by UPHS phlebotomy and/or analyzed by the hospital laboratory?
Yes
Anatomic Pathology Services*
Will tissue specimens (other than blood) be collected for clinical, diagnostic, or research purposes OR 
be processed through surgical pathology, cytopathology, neuropathology, or hematopathology?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A

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Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures , whether considered routine care or strictly for research purposes? (UPHS includes all Penn 
hospitals and clinical practices, including the Clinical Care Associates network of community 
practices). Examples of UPHS services/tests/procedures includes the Clinical Translational Research 
Center (CTRC), laboratory tests, use of the pathology lab, cardiovascular imaging tests or radiology 
imaging tests (whether being billed via the Service Center or through UPHS), other diagnostic tests & 
procedures and associated professional services, etc. 
Yes
Veteran's Affairs (VA) Patients or Subjects
Does your study involve data from Veteran's Affairs (VA) patients or subjects?
No
If yes, was this approved by the Philadelphia VA?
No
Out of State Research
Will any Penn personnel conduct any research activities outside of the State of Pennsylvania?
No
Research involving Virtua Health
Will any Penn personnel conduct any research activities at a Virtua Health site location, OR in 
collaboration with Virtua Health System personnel, OR using any Virtua Health System resources (e.g., 
medical records)?
No
Primary Focus*
Sociobehavioral (i.e. observational or interventional)
Protocol Interventions
x Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
x Survey instrument
None of the above
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Sponsors
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Name:
COMMONWEALTH FUND
Type:
UPENN Foundations
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
No
Regulatory Sponsor
IND/IDE Sponsor
none
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Industry Sponsor
None
Project Funding*
Is this project funded by or associated with a grant or contract?
Yes
Selected Proposals
Proposal No
Title
10070413
Using Digital Health, Financial Incentives and Community Health Worker Support to Change Health B
Sponsor Funding
Is this study funded by an industry sponsor?
No

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Status of contract
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Multi-Center Research
Penn as lead
1. Is this a multi-center study where Penn is serving as the Lead Site or the Penn PI is serving as the
Lead Investigator?
No
Management of Information for Multi-Center Research
Penn irb of record
2. Is this a multi-center study where the Penn IRB will be asked to serve as the IRB of Record for other
external study sites?
No
Other Sites
No other sites
Protocol
Abstract
Low-income Americans struggle to stay healthy in the face of real-life challenges such as housing 
insecurity or trauma. Two interventions show promise for promoting behavior change and improving 
health outcomes: digital health interventions coupled with ﬁnancial incentives (DFI) and community 
health workers (CHWs). Yet, these interventions have limitations; DFI interventions have low uptake 
and high attrition among vulnerable populations, while CHW interventions are relatively resource 
intensive.  We will conduct a 24-week randomized trial of a hybrid DFI/CHW intervention among a 
population of 150 low-income patients with diabetes. Participants will be randomized to one of three 
arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, 3) usual care. Participants assigned to DFI 
will receive a free wireless glucometer if they dont already have one and be eligible for a lottery 
incentive if they use their glucometer. Participants assigned to the hybrid DFI/CHW intervention will 
receive the same glucometer if they dont already have one and incentives. If they exhibit low adherence 
to self-monitoring or poor glucose control, they will also receive support from a CHW who would help 
patients to address underlying socioeconomic barriers and cope with setbacks. We hypothesize that 
compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-
monitoring and greater improvements in glycosylated hemoglobin.
Objectives
Overall objectives
A trial of a hybrid DFI/CHW intervention that incorporates strategies for coping with failure among a 
population of low-income patients with diabetes. Diabetes is an ideal condition in which to test this 
innovative intervention; the challenges of carrying out healthy behaviors for patients with diabetes have 
been well described. In addition, the enormous public health and economic challenge of diabetes is 
concentrated among disadvantaged populations: 18% of African Americans and 16% of people without 
a high school education have diabetes. Finally, diabetes is a condition that is well-suited to the study of 
self-monitoring, which appears to be a key factor in behavior change: glucose self-monitoring improves 

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outcomes among insulin-requiring diabetics and glucometers are covered by Medicaid in all states.  A 
diabetes-speciﬁc trial can provide valuable insights that can be extrapolated to other diseases. Digital 
health applications extend to monitoring of weight, medication adherence, physical activity, blood 
pressure and other conditions. IMPaCT is adaptable and has been tested across many diseases. If we 
establish the effectiveness of a hybrid DFI/CHW intervention in this population, we will be able to 
generalize the intervention more broadly to improve health among low-income patients.  We will test an 
innovative hybrid of two of the most promising and synergistic approaches for improving health among 
low income people in a way that is guided by behavioral and social science. This study will provide 
new knowledge of the pathways to behavior change and has the potential to improve the health of low-
income individuals.
Primary outcome variable(s)
Primary outcome: Adherence rate (constructed by summing the number of days in the study period that 
the glucometer was used divided by the total number of days in study period.)
Secondary outcome variable(s)
The secondary outcome measure will be change in glycosylated hemoglobin from baseline to 24 weeks 
follow-up assessment.
Background
In the 21st century, in the most developed country in the world, a black man living in poverty in 
Southwest Philadelphia dies of diabetes at the age of 45. He is not unique. Low-income Americans have 
higher rates of almost every disease and die 15 years sooner than wealthier counterparts who live just a 
few blocks away. Why and what can be done?  Health and health inequity are heavily inﬂuenced by 
personal behaviors; staying healthy requires devoting energy and resources to performing certain 
behaviors (exercise, diet, medication adherence, etc.) and avoiding others (smoking, alcohol, etc.). 
Engaging in health-promoting behavior is challenging, especially in the face of socioeconomic barriers 
like food insecurity or joblessness. In essence, low-income individuals run a difﬁcult race with a severe 
handicap.  A conceptual framework is useful for understanding the hurdles that an individual must 
overcome in the path to healthy behavior. Figure 1 is a framework that draws from three evidence-based 
models for behavior-dependent outcomes: the Reasoned Action Approach, the Health Belief Model and 
the Transtheoretical Model (Stages of Change). For an individual to even intend to initiate a behavior, 
her attitudes, social norms, and self-efﬁcacy must all fall in line. Once an individual intends to initiate a 
behavior, she can be thwarted by external barriers. If she manages to initiate a behavior, she will still 
require reinforcement in order to turn the behavior into a habit. Fortunately, there have been two 
categories of interventions that show promise for promoting behavior change and improving health 
outcomes: digital health interventions and community health workers (CHWs).  Digital health 
interventions use computers, mobile phones or devices to encourage self-monitoring of health metrics 
like blood glucose or weight. By raising an individuals awareness of their metrics and attendant health 
risks, digital interventions can shift attitudes to promote healthy behavior (Figure 2A). Digital 
interventions can be augmented by behavioral economic engagement strategies such as lottery-based 
ﬁnancial incentives, which serve to reinforce self-monitoring behavior so that it becomes a habit (Figure 
2A). Our study team has run dozens of digital and ﬁnancial incentives (DFI) interventions; these have 
signiﬁcantly increased physical activity, improved glycemic control, smoking cessation rates, and 
helped people lose weight. The ongoing advances in technologies related to wearable tracking devices 
and point of-care testing are likely to fuel increasing interest in DFI interventions. Yet, recent meta-
analyses show that these approaches are limited by low uptake and high levels of attrition over time. In 
one of our recent studies, the rate of adherence to daily glucose self-monitoring was only 60% over a 6-
month period, even with the addition of lottery-based ﬁnancial incentives. Increasing success rates, 
particularly among vulnerable populations, will likely require additional support to address underlying 
socioeconomic barriers that make it hard for low-income people to manage their health in the ﬁrst 
place. Otherwise, struggling patients may ﬁnd it self-defeating to monitor elevated sugars, weight or 
blood pressure without the necessary supports to correct them.15 Community health workers (CHWs) 
are trusted laypeople from the local community who can be hired and trained by healthcare 
organizations to support patients. Their shared identity with low-income patients allows CHWs to 
inﬂuence attitudes, shift social norms, bolster self-efﬁcacy through strategies like motivational 
interviewing, and address socioeconomic barriers to healthy behaviors (Figure 2B). CHW interventions 
are increasingly being used to improve health in disadvantaged communities and can improve chronic 
disease outcomes, but often are disease-speciﬁc, difﬁcult to scale across institutions or lacking in high-
quality evidence. Our study team has developed a standardized, scalable CHW intervention called 

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IMPaCT, which has been tested in three randomized clinical trials and demonstrated to improve a range 
of outcomes including chronic disease control, mental health, access to care and quality of care while 
reducing total hospital days by 65%.  Despite its effectiveness, like any intervention, IMPaCT does not 
work for all people. We recently conducted an in-depth process evaluation to understand factors 
contributing to non-response (deﬁned as failure to improve chronic disease metrics such as glycemic 
control). We found, unsurprisingly, that all patients thought health behavior change was challenging and 
experienced set-backs. However, responders learned from these setbacks and increased their resolve, 
while non-responders became discouraged and shut down. These non-responders disengaged from their 
CHWs and also avoiding any self-monitoring that reminded them of their failure. Thus, we learned that 
in order to augment the effectiveness of IMPaCT -- and potentially other behavioral interventions 
including DFI interventions -- we would need to help patients cope with failure. A recent behavioral 
science experiment we conducted, has shown that walk test challenges can be helpful in predicting 
whether patients will be responders or non-responders.  In summary, increasing healthy behaviors is 
challenging, particularly for low-income individuals who face socioeconomic challenges. DFI and 
CHW interventions can be effective, but have limitations. DFI interventions do little to address 
underlying socioeconomic challenges, and thus may have low uptake and high attrition among 
vulnerable populations. CHW interventions like IMPaCT can address these challenges, but are 
relatively resource intensive. Both DFI and CHW interventions may be less effective within a subgroup 
of people who are discouraged by failure.
Study Design
Phase*
Not applicable
Design
A blinded, 24-week trial of a hybrid DFI/CHW intervention among a population of low-income patients 
with poorly controlled diabetes. Participants would be randomized to one of three arms: 1) DFI 
intervention alone, 2) hybrid DFI/CHW intervention, 3) usual care. Participants assigned to the DFI 
alone arm would receive a free wireless glucometer if they dont already have one and be eligible for a 
lottery incentive if they use their glucometer. Participants assigned to the hybrid DFI/CHW intervention 
would receive the same glucometer if they dont already have one and lottery incentives. If, despite these 
strategies, they exhibited low adherence to self-monitoring or poor glucose control, they would also 
receive support from an IMPaCT CHW. The CHW support would incorporate two behavioral strategies 
which have been shown to help individuals cope with failure: positive affect induction and attribution 
retraining.  Interventions: DFI Alone Arm: Participants will receive a free wireless glucometer if they 
dont already have one on the day of enrollment. To encourage habit formation, for the ﬁrst 6 weeks of 
the trial, participants will be eligible for a daily lottery incentive for every day that they use their 
glucometer. We will use an approach similar to what we have used in prior DFI trials: the lottery will 
provide infrequent large payoffs (a 1 in 100 chance of a US$50 reward) and more frequent small 
payoffs (an 18 in 100 chance of a US $5 reward). The total average amount of ﬁnancial incentives from 
these lotteries will be modest: an expected value of US$1.40 per day. Participants who draw the 
winning lottery number, but did not check their glucose the day prior will receive an automated text or 
e-mail message informing them what earnings they would have won had they used their glucometer.
After 6 weeks, we will terminate the lottery but continue to monitor patients adherence to glucose self-
monitoring. A clinician at the practice site will receive notiﬁcations if participants glucose is either
extremely low or high (60 or 400 mg/dL). Participants with these readings will receive messages to
contact their healthcare provider immediately. Hybrid DFI/CHW Arm: Participants in the hybrid
intervention will receive a wireless glucometer if they dont already have one and ﬁnancial incentives
just as in the DFI intervention. However, any individuals who have low adherence (no self-monitoring)
or elevated glucose readings (300 mg/dL) for 30% of days over any 2 week period in the ﬁrst 12 weeks
of the study will be assigned to receive ongoing CHW support for the duration of the 24-week study
period (Figure 3). Based on prior studies, we estimate that 50% (25 of the 50 patients in to the hybrid
intervention) will require support from a CHW. Once a CHW receives notiﬁcation of a struggling
patient, she will visit the patient at home within 1-2 days to initiate the IMPaCT intervention.
Study duration
Each participant will be in the study for 6 months. Due to the restrictions on in-person clinic visits due 
to COVID-19, follow-up study visits may need to be completed outside of the 6-month window (for 
collection of glucometer data and hemoglobin a1c values -- which cannot be obtained telephonically). 

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The intervention period of the study (during which patients may receive support from a CHW, and may 
participate in bi-directional texting) will be unchanged in duration.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
Dr. Kangovi, the principal investigator (PI) of the proposed project, is a leading national expert on 
improving population health through community health workers (CHWs). She also has extensive 
experience with using mixed methods research to understand perspectives of low-income patients on 
health and health behaviors. Dr. Kangovi led the community-academic-health system team that 
designed the IMPaCT model. She has authored numerous scientiﬁc publications in publications such as 
NEJM, JAMA and Health Affairs and received over $20M in funding, including federal grants from the 
NIH to study health behavior, speciﬁcally how low-income patients respond to failed attempts at 
behavior change. Dr. Kangovi is the founding executive director of Penn Center for Community Health 
Workers, a national center of excellence dedicated to advancing health in low-income populations 
through effective CHW programs. Dr. Kangovi has experience with all the proposed methods, including 
adapting IMPaCT for use in new settings and developing behavioral interventions to support patients in 
coping with failure. In addition, Dr. Kangovi has worked previously with most members of the study 
team, including co-authorship of research papers. As PI, Dr. Kangovi will oversee the entire study and 
provide oversight for delivery of the CHW intervention. She will be responsible for the completion of 
all aspects of the study including data collection, analyses, presentations, manuscript development, and 
results dissemination.  Dr. Judith Long is the Co-Director of the Center for Health Equity Research and 
Promotion (CHERP) at the Corporal Michael J. Cresenz VA Medical Center (CMCVAMC), and has 
been a core faculty member since CHERPs inception in 2001. Dr. Long has substantial administrative 
experience as the Chief of the Division of General Internal Medicine at the University of Pennsylvania 
(UPENN) Perelman School of Medicine. Her recent research focuses on interventions to reduce 
disparities in health using peer mentors, community health workers, and behavioral incentives. She has 
extensive experience directing clinical research trials to improve outcomes for patients with chronic 
diseases. She recently completed two randomized controlled trials (RCTs) of peer mentoring and 
ﬁnancial incentives for adults with poorly controlled type 2 diabetes. With CEPACT support, she began 
investigating the long-term effectiveness of peer mentoring and leveraged that work to secure VA 
HSR&D funding (IIR 12-407) to evaluate whether former mentees can be trained to be effective peer 
mentors. Dr. Long has worked closely with Dr. Kangovi since 2010. Dr. Long will work closely with 
Dr. Kangovi on design, conduct, and analysis.  Dr. Nandita Mitra is a Professor of Biostatistics at the 
Hospital of the University of Pennsylvania, Perelman School of Medicine and the Director of Statistics 
of the Masters in Health Policy Research Graduate Program at the University of Pennsylvania, and 
afﬁliated faculty member with the Center for Clinical Epidemiology and Biostatistics. Dr. Mitra 
conducts methodological and collaborative research in the areas of causal inference and outcomes 
research. Her methods research focuses on the development of statistical methods for the analysis of 
observational data, health economic data, and population-based genetic data. She has developed 
propensity score based methods for bias reduction in cost effectiveness and cancer risk studies. She has 
also developed regression based methods to assess the sensitivity of treatment effects to unmeasured 
confounding and hidden bias. She has been the lead statistician on Dr. Kangovis prior studies. These 
collaborations with the study team and other Penn faculty members have led to important publications 
in JAMA Internal Medicine, Statistics in Medicine, JAMA, Nature Genetics, Cancer Research, and 
JNCI.  As a co-investigator and biostatistician on this study, Dr. Mitra will direct all analyses; assist 
with data interpretation, manuscript preparation, and presentations. Speciﬁcally, she will test our 
hypotheses with an intent-to-treat analysis using a modiﬁed Poisson regression model to obtain relative 
risk of low adherence and a linear regression model to obtain the between-arm difference in change in 
glycosylated hemoglobin. An information systems support fee of $609, for consultation with faculty 
members in the Center for Clinical Epidemiology and Biostatistics, is also applied to the budget for Dr. 
Mitra. Mr. Rory Harte is a Clinical Research Coordinator for the Perelman School of Medicine at the 
University of Pennsylvania. Mr. Harte has worked for the Penn Center for Community Health Workers 
for over four years, providing programmatic, research, and evaluation support. Mr. Harte began his 
work at Penn as a clinical research assistant on a PCORI-funded, multi-center randomized control trial. 
He was instrumental in subject enrollment, data collection, participant follow-up, and remuneration at 
multiple sites. He gained experience with both quantitative and qualitative data collection and analysis. 

Page 12
Mr. Harte was promoted to Clinical Research Coordinator and helped to transition the study into a 
clinical program embedded with the University of Pennsylvania Health System and the Corporal 
Michael J. Crescenz Veterans Affairs Medical Center. Additionally, Mr. Harte has worked as a clinical 
research coordinator on a behavioral science study in which he was responsible for reviewing literature 
and identifying useful survey instruments; developing study protocols; creating a research database and 
manual; meeting with clinic staff; supervising staff; and corresponding with the Institutional Review 
Board. Mr. Harte will work closely with Dr. Kangovi to oversee the day-to-day aspects of the study. 
Speciﬁcally, he will develop and maintain eligibility lists for recruitment purposes; coordinate and 
maintain IRB approval for the study; manage the tracking database of outcomes; supervise the work of 
the research assistant; assist with writing reports and correspondence with Commonwealth Fund; and 
coordinate quarterly meetings with all study team staff.  The research assistant will have a minimum 
college education and will undergo a 1-week training which covers topics including survey 
interviewing, data entry, HIPPA and Human Subjects training. The research assistant will be 
responsible for interfacing with Way to Health platform, recruiting and enrolling patients, verbally 
administering the baseline and follow-up surveys, monitoring adherence and lottery, tracking laboratory 
results, and entering outcomes data.
Characteristics of the Study Population
Target population
Diabetes patients of low socioeconomic status living in high poverty zip codes of West/Southwest 
Philadelphia.
Subjects enrolled by Penn Researchers
150
Subjects enrolled by Collaborating Researchers
0
Accrual
We will enroll 150 patients (50 in each arm) from the Penn Rodebaugh Diabetes Center at the Perelman 
Center for Advanced Medicine.
Key inclusion criteria
Key inclusion criteria: We will enroll patients who meet the following eligibility criteria: 1) Penn 
Medicine patients diagnosed with diabetes mellitus (based on ICD-10CM codes from the year prior to 
study enrollment); 2) glycosylated hemoglobin 9% within the past 6 months; 3) requires insulin; 4) 
uninsured/publicly insured; 5) residents of high-poverty ZIP codes in West/Southwest Philadelphia; 6) 
have access to a cellphone with unlimited text message capabilities; 7) greater than or equal to 18 years 
of age.
Key exclusion criteria
Key exclusion criteria: We will exclude patients who: 1) already have pumps that do continuous glucose 
monitoring; 2) were previously enrolled in the study; 3) are unwilling/unable to provide informed 
consent; 4) currently have a community health worker; 5) are in another study that asks participants to 
monitor their blood sugar.6) unable to speak and read comfortably in the English language

Page 13
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Populations vulnerable to undue inﬂuence or coercion
The consent form is explicit about the absence of any consequences with respect to employees refusal 
to be involved in the protocol as a research participant altogether. The informed consent form is explicit 
about the absence of any consequences to refusing to participate in the study. We will be reimbursing 
participants up to $200 over the course of the six month study period, as well as $20 upon completion 
of an optional in depth qualitative interview. We feel this is a modest amount so that the compensation 
will not be unduly coercive even though we expect most of the participants to be low income and 
minority.
Participant recruitment
Please describe the plan to equitably identify and recruit a diverse group of participants that is reﬂective 
of the population under study. If this is a multicenter protocol, the recruitment plan should describe the 
local (Penn) site's plan. Describe:how potential participants may be identiﬁed (review of medical 
records, Slicer Dicer, DAC reports including referrals from physician ofﬁces and clinics);who may 
approach potential participants;methods to achieve sample diversity and inclusiveness;what information 
may be presented to or discussed with them; andthe context and setting in which recruitment will 
happen.
Each week, study coordinators will receive automated lists of eligible patients with upcoming 
appointments throughout Penn Medicine. Trained research assistants will call these patients and ask if 
they would be willing to plan additional time during their clinic visit for study enrollment. When 
interested patients arrive to their clinic visit, the research assistant will obtain written informed consent 
and begin the study.  We will primarily be working with the Rodebaugh Diabetes Clinic. We have 
established relationships with clinic providers and staff and we were invited to conduct our study at the 
clinic. The providers at the clinic have approved our recruitment procedures and are aware that we will 
be contacting their patients to invite them to participate in this study. We will obtain PHI from the Penn 
Data Store for the purposes of recruitment. Patients will need to be contacted before appointments in 
order to ensure they budget enough time to participate. In order to call patients, we need their name and 
phone number. We need to know patients zip codes because it is part of the inclusion criteria. If we did 
not limit our recruitment list by zip code, the number of patients to contact would be immense and 
unmanageable. We need to know patients date of birth to conﬁrm they are over the age of 18 years old. 
We need to know patients medical record number and date of birth to verify their identity.  The 
following is an excerpt pulled from the Notice of Privacy Practices that all patients are required to 
review: as an academic medical center Penn Medicine supports research and may contact you to invite 
you to participate in certain research activities. Given this information, it is our understanding that 
patients do not have to agree to be contacted ahead of time. In addition to calling potential study 
participants, we will also send recruitment mail cards to Penn Medicine patients who may be eligible 
for the Engage study. We will obtain mailing information via the Data Analytics report we already 
receive as part of our study recruitment process. . We are currently using a report from Penn Data 
Analytics to identify potentially eligible participants for recruitment phone calls. We propose to use this 
same list to identify potentially eligible participants to whom we may send recruitment post cards. We 
will not be expanding the pool of participants we are contacting under this new proposed recruitment 
strategy. Rather, we will be employing a new method (mail) to reach the same participants we may 
otherwise be attempting to contact via phone.We have attached a copy of our proposed mail card to this 
submission.  In order to track which participants have agreed or not agreed to be in the study and why, 

Page 14
we store information about all screened patients in redcap. This information includes, ﬁrst name, last 
name, medical record number, age, gender, clinic, problem list, and insurance. This information is used 
to conﬁrm their eligibility prior to contacting them via phone. The phone script is in the RA manual that 
is attached.
Recruitment Materials
Is the research team using any recruitment materials? These may include but are not limited to: phone 
call scripts, radio/video scripts, ﬂyers/brochures, internet postings, email, letters to potential 
participants, letters to patient physicians, My Penn Medicine (MPM), other direct messaging, etc. For 
guidance regarding recruitment materials, please review the IRB's guidance on Participant Recruitment 
Materials online:https://irb.upenn.edu/recruitment
No
Use of Penn Media & Social Media Services
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Participants will receive a $50 pre-paid gift card upon completion of enrollment (baseline survey and 
laboratory testing) and $50 upon completion of a 3 month follow up visit for glucometer data extraction 
and ﬁnally $100 gift card at the 6 month follow-up assessment (baseline survey, laboratory testing, and 
glucometer data extraction.) Participants who complete a qualitative interview will receive an additional 
$20 gift card. We are submitting a piece of paper that we would like to give to participants explaining 
when they can expect to be paid for the study. We hope this will offer clarity to the process used for 
uploading money onto ClinCards.We have uploaded a copy of this document below. Due to restrictions 
on in-person non-essential research visits due to COVID-19, we propose to split 3-and 6-month study 
compensation into 2 payments. For 3-month study visits, we will look to conduct adverse event 
screening with patients telephonically, for which they will receive 1 half ($25) of their 3-month 
compensation. As soon as is safely possible, will aim to complete an in-person 3-month visit, to collect 
biometric data (from patient glucometes). At the completion of this component of the 3-month visit, 
patients would be provided with the other half ($25) of their 3-month compensation. Simliarly, for 6-
month follow-up we will aim to complete adverse event screening and psychometric surveys via 
telephone, for which subjects will be compensated 1 half $50) of the 6-month compensation. Then, as 
soon as possible, we will look to complete the 6-month biometric data collection for glucometer data 
and hemoglobin a1c testing. At the completion of these steps, participants would receive the other half 
($50) of the 6-month follow-up compensation.  o Due to the COVID-19 pandemic, we have been 
delayed in completing study follow-up visits. Given that participants are not able to complete follow-up 
visits as scheduled we have not been able to dispense follow-up compensation to study participants at 
the anticipated times (approximately 3- and 6- months post-enrollment).  In order to honor the ﬁnancial 
expectations we set with participants, we propose to attempt to send follow-up payments to participants 
with whom we are unable to meet due to COVID, regardless of whether they complete any follow-up 
activities. Speciﬁcally, for any patients whose planned follow-up date has already passed, we will aim 
to provide the full follow-up visit compensation amount via ClinCard as soon as possible. For patients 
with future planned follow-up visit dates, if the date of their planned follow-up arrives, and we are still 
unable to meet with them due to COVID, we will aim to issue their full visit compensation via ClinCard 

Page 15
as close to that time as possible. As outlined in a prior modiﬁcation (approved 4/1/20), we will look to 
complete some follow-up visit activities telephonically during this time for partial compensation (in 
addition to the compensation described above). Additionally, once safety restrictions are lifted and non-
essential in-person research visits resume, we will look to meet with as many participants as is feasible 
to complete in-person follow-up activities, for further partial compensation. Participants will be 
compensated for these follow-up activates as outlined in the previously approved modiﬁcation.  We will 
attempt to alert patients via phone and/or mail ahead of an electronic transmission of payment. For 
participants who no longer have the CliniCard we issued to them earlier in the study, we will attempt to 
issue a new CliniCard via mail as soon as possible.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? Centeral nervous system(CNS) 
effect: the ability of a test article to enter into and potentially interact with the central nervoous system 
(brain and spinal cord). Clinical Investigation: Any experiment that involves a test article and one or 
more human subjects that either is subject to requirements for prior submission to the Food and Drug 
Adminstration (FDA) under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is 
not subject to the requirements for prior submission to the FDA under these sections of the act, but, the 
results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an 
application for a research or marketing permit. 
No
Procedures
Participants interested in enrolling into the study will go through the following procedures:  Step One: 
Consent and Goal-Setting 1. Explain the study to the patient using the consent form. Obtain two signed 
copies of the consent.  2. Use the IMPaCT goal card to help the patient choose a reasonable HbA1c goal 
to reach by the end of the six month study period. Step Two: 1. Administer the baseline redcap survey.  
Step Three: The Walk Tests (All parts of Step Three are optional and patients will be asked if they want 
to participate in this part of the study) 1. Take the patient to the walk test area. Ask the patient to sit at 
rest in a chair for a few minutes. During this time, explain the walk test to the patient: We would like 
you to participate in 2 or 3 walk tests. These tests can help us understand how you may react to this 
study, which asks you to monitor your blood glucose. We will ask you to complete a short walk test, 2 
or 3 times. Before the test starts, check for contraindications, baseline oxygen saturation via pulse ox, 
pulse, and blood pressure. Patients should use their usual walking aids during the test(cane, walker, 
etc.). 3. Contraindications to administering the 1 minute walk test are: 1) resting heart rate of more than 
120, 2) a systolic blood pressure of more than 180 mm Hg, 3) and a diastolic blood pressure of more 
than 100 mm Hg. If at the study visit, a patient cannot participate in the walk test because of a 
contraindication, the patient can complete all other aspects of the study. If the patient has any of these 
contraindications or a Sp02 less than 88%, this constitutes a clinical emergency and the principal 
investigator should be contacted immediately.  4. If no contraindications exist, set the timer to 1 minute. 
Assemble all necessary equipment (timer, clipboard, worksheet, cones) and move to the starting point. 
5. Trial One (Practice Trial)  a. After explaining the instructions, position the patient at the starting line.
Say Start now, or whenever you are ready.  b. Record the number of laps the patient walked from the
tick marks on the worksheet. And record the additional distance covered (the distance in the ﬁnal partial
lap). Calculate the total distance walked.  c. Congratulate the patient on their good effort and offer a
drink of water. d. Give the patient a rest period. (Vitals will not be repeated before trials 2 and 3) 6.
Trial Two (Performance Trial)  a. After a rest period, ask participants to complete a second walk test
with the goal of exceeding their prior performance (total distance walked) by 40%. (You should
calculate the distance and just tell them that, not the percent). b. Conduct the walk test as above.  c.
After the walk test, tell the patient if they succeeded or failed at reaching their goal.  7. Trial Three
(Outcomes Trial) a. Offer participants the choice of repeating their walk trial. "Now, I'd like to give you
the option of doing another walk test to see if you can improve. Do you want to try again?" If they
choose not to do Trial 3, leave their Trial 3 performance distance walked blank and move on.  b. Repeat
the walk test as above. c. After the completion of all the walk tests, thank the patient.  Step Four: Set up
Way to Health Account 1. Enter the patient into the way to health platform.  2. Test that they provided

Page 16
the correct phone number using contact veriﬁcation technology.  Step Five: Labs 1. Walk the patient to 
the laboratory to have their blood drawn for HbA1c evaluation. 2. Provide the patient with a gift card 
and half page sheet with payment information Step Six: How to Use the Glucometer 1. Provide the 
patient with a glucometer if they don't already have one.  2. Review the user guide with the patient and 
answer any questions they may have about using their glucometer.  3. Reinforce/explain to the patient 
not to delete their glucose reading log from the glucometer because we will extract the log from the 
glucometer at subsequent visits. Abnormal Blood Glucose Safety Protocol:  The study clinician will be 
notiﬁed by the way to health platform if participants glucose is either extremely low or high (60 or 400 
mg/dL) and respond accordingly. The study clinician will contact these patients to address the issue.  
Step Seven: CHW escalation  1. The way to health platform will notify the study team of any 
individuals who have low adherence (no self-monitoring) or elevated glucose readings (300 mg/dL) for 
30% of days over any 2 week period in the ﬁrst 12 weeks of the study. These individuals will be 
assigned to receive ongoing CHW support for the duration of the 24-week study period 2. The study 
team should notify the CHW and send them the patients redcap ID. The CHW will follow up with the 
patient in 1-2 days.  Step Eight: 3 Month Follow Up 1. One month prior, contact the patient to set a 
date/time for their 3 month follow up appointment.  (If patients are unable to be reached, then we will 
send a letter to their home requesting that they contact us to set up a follow-up appointment.) 2. At the 
appointment, obtain the blood glucose log of readings from the patients glucometer.  3. Provide the 
patient with a gift card. Follow up visit is concluded. 4. The window to complete all 3-month follow-up 
procedures may be extended in cases where patients were prevented from completing visits within the 
original window due to COVID-19 restrictions.  Step Nine: 6 Month Follow Up and Labs 1. One month 
prior, contact the patient to set a date/time for their 6 month follow up appointment.  (If patients are 
unable to be reached, then we will send a letter to their home requesting that they contact us to set up a 
follow-up appointment.) 2. At the appointment, obtain the blood glucose log of readings from the 
patients glucometer. 3. Administer the follow up redcap survey  4. Walk the patient to the laboratory to 
have their blood drawn for HbA1c evaluation. 5. Provide the patient with a gift card. Follow up visit is 
concluded. 6. The window to complete all 6-month follow-up procedures may be extended in cases 
where patients were prevented from completing visits within the original window due to COVID-19 
restrictions.  Any Engage Study patients screened for recruitment into routine care community health 
worker programs at Penn Medicine will have their enrollment deferred until their study participation is 
complete. We will track all screened patients that are deferred because of Engage Study participation 
and contact them afterwards to offer enrollment into our routine care community health worker 
program. You may also be contacted during this study as a part of our quality review. If this happens 
you will just be asked a few questions about how the study has been going and your experiences with 
the steps listed above.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception? Deception could be considered any direct misinformation presented to 
the subject or omission of key information pertaining to the design or nature of the project. 
No
International Research
Are you conducting research outside of the United States? 
No
Analysis Plan
Hypotheses 1. We hypothesize that over the 24-week study period, compared to usual care, the hybrid 
intervention will lead to a higher rate of adherence to daily glucose self-monitoring.  2. Our secondary 
hypothesis is that compared to DFI alone, the hybrid intervention will lead to a higher rate of adherence 
to daily glucose self-monitoring. 3. Our exploratory hypotheses are that compared to usual care and DFI 
alone, the hybrid intervention will lead greater improvements in glycosylated hemoglobin. Outcome 
measures The primary and secondary outcome measures will be adherence rate (constructed by 
summing the number of days in the study period that the glucometer was used divided by the total 
number of days in study period). The exploratory outcome measure will be change in glycosylated 
hemoglobin from baseline to 24 weeks follow-up assessment.  Statistical analyses We will test our 
hypotheses with an intent-to-treat analysis using a modiﬁed Poisson regression model to obtain relative 

Page 17
risk of low adherence and a linear regression model to obtain the between-arm difference in change in 
glycosylated hemoglobin. We will adjust these models for any unbalanced baseline covariates to 
increase efﬁciency.  For exploratory purposes, we will do a per protocol analysis focusing on the 
subgroup of patients in the hybrid intervention who actually received CHW support, as compared to the 
patients in the DHI alone arm who would have received support based on low adherence or elevated 
glucoses. We will also explore predictors of adherence and glycosylated hemoglobin across all three 
arms.  Sample size calculations Based on a similar 24-week trial, we assume that the adherence rate in 
the usual care arm will be 40% and the rate in the hybrid intervention will be 80%. In the prior trial, the 
adherence rate in the usual care arm was 47%; however this trial had a lower risk population (higher 
income and lower baseline glycosylated hemoglobin), and a longer ﬁnancial incentive period. In this 
same trial, the adherence rate for the DFI alone arm was 70%; therefore the estimate of 80% adherence 
in the hybrid DFI/CHW arm seems reasonable. Using a two-sample comparison of proportions (usual 
care versus hybrid), we will require a sample size of 28 patients per arm to detect these differences with 
80% power, assuming a Type I error rate of 0.05. Given the vulnerability and transience of this patient 
population, it is important to account for loss to follow-up, which we assume based on prior trials to be 
20%. Therefore, we estimate that we will have to enroll 34 patients in each arm to end up with our 
minimal sample size. Our planned enrollment of 50 patients in each arm will easily allow us to meet 
this threshold.  Our planned sample size will also allow us to detect a difference between DFI alone and 
hybrid arms (the secondary outcome), assuming the DFI arm has an adherence rate of 48% and the 
hybrid arm has a rate of 80%. In reality, we might see higher adherence than 48% in the DFI alone arm 
based on a prior similar trial as above in which the DFI arm had a 70% adherence. However, it is 
possible in this trial focusing on a vulnerable population, DFI alone may result in lower adherence. 
Missing data Efforts will be made to collect complete information on patients including 3 attempts to 
contact each patient via telephone and the provision of honoraria for completion of follow-up. We will 
check the medical record of those lost to follow-up and extract from the electronic medical record any 
relevant glycosylated hemoglobin that occurred within 4 weeks of the study completion date. We will 
track all missing values and assess the pattern of missing data and whether the missingness is non-
ignorable. If appropriate, we will consider statistical methods such as multiple imputation.
The following documents are currently attached to this item:
There are no documents attached for this item.
Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
x Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
x Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
x Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
To ensure that participant conﬁdentiality is maximized, only trained, designated research staff will be 
given access to participants medical records and research data, including informed consent forms. Data 
management will occur through REDCap , a secure web application and back-end database model, 
developed at Vanderbilt University with collaboration from a consortium of institutional partners. RAs, 

Page 18
CHWs and clinicians will enter data directly into REDCap, which obviates the need for transferring 
written data into electronic form; this signiﬁcantly improves the quality of data. Penn has licensed its 
own version of REDCap housed on our own servers located within a University of Pennsylvania Health 
System (UPHS) data center inside the UPHS ﬁrewall and therefore afforded the same network 
protections as all UPHS sensitive clinical data. REDCap was developed speciﬁcally around 
HIPAASecurity guidelines and is recommended to Penn Medicine researchers by our Ofﬁce of Human 
Research. Relevant HIPAA-compliant features include password-protected access to the system, 
restriction of access to speciﬁc clinical trial data to designated users, audit trails of access and data 
updates, and built-in de-identiﬁcation functions that can be used when exporting data for analysis. 
REDCap has been disseminated for use locally at other institutions and currently supports 170 
academic/non-proﬁt consortium partners on six continents and 13,000 research end-users 
(www.project-redcap.org). RAs and goal-supporters can access REDCap through a web-based interface 
and securely input data from any location at the time of data collection minimizing the need for 
travelling with either electronic or paper versions of sensitive information. Audio recordings of 
qualitative interviews will be temporarily stored on a password protected, PGP-Netshare encrypted 
HIPAA secure network drive behind the ﬁrewall of the Division of General Internal Medicine server. 
This network drive was established per the advice and recommendation of the Division of General 
Internal Medicines UPHS afﬁliated Local Support Provider within Penn Medicine Academic 
Computing Services. Once the audio ﬁles are uploaded to the transcription service website and the 
written transcripts are returned the audio recordings will be destroyed. Interview transcripts will then be 
uploaded to REDCap. Written communication to study participants will also be stored on this drive 
which is accessible only by members of the research team. A unique participant identiﬁer will be used 
for linkage of Personal Health Information (PHI) to research databases. The unique study identiﬁcation 
number, and no other identifying information, will be used on all data collection instruments. The only 
paper forms that will be used in this study are: 1) informed consent documents and 2) human subject 
vouchers for participant incentives. These paper forms will be securely stored in a locked cabinet in the 
School of Medicine. One exception to the utilization of paper forms is as follows: In the event that data 
is unable to be directly entered into REDCap for any reason (e.g. due to a technological system failure), 
a paper copy of the corresponding Data Collection Instrument will be utilized and the Data will then be 
transcribed from the paper form and entered into REDCap immediately after any technological issues 
are rectiﬁed. The paper form will be retained as a source document. Research material will be obtained 
from participant surveys and from glucometers. All participants will provide informed consent for 
access to these materials. Research material that is obtained will be used for research purposes only. 
The Penn Medicine Academic Computing Services (PMACS) will be the hub for the hardware and 
database infrastructure that will support the project and is where the Way to Health web portal is based. 
The PMACS is a joint effort of the University of Pennsylvania's Abramson Cancer Center, the 
Cardiovascular Institute, the Department of Pathology, and the Leonard Davis Institute. The PMACS 
provides a secure computing environment for a large volume of highly sensitive data, including clinical, 
genetic, socioeconomic, and ﬁnancial information. Among the IT projects currently managed by 
PMACS are: (1) the capture and organization of complex, longitudinal clinical data via web and clinical 
applications portals from cancer patients enrolled in clinical trials; (2) the integration of genetic array 
databases and clinical data obtained from patients with cardiovascular disease; (3) computational 
biology and cytometry database management and analyses; (4) economic and health policy research 
using Medicare claims from over 40 million Medicare beneﬁciaries. PMACS requires all users of data 
or applications on PMACS servers to complete a PMACS-hosted cybersecurity awareness course 
annually, which stresses federal data security policies under data use agreements with the university. 
The curriculum includes Health Insurance Portability and Accountability Act (HIPAA) training and 
covers secure data transfer, passwords, computer security habits and knowledge of what constitutes 
misuse or inappropriate use of the server. We will implement multiple, redundant protective measures to 
guarantee the privacy and security of the participant data. All investigators and research staff with direct 
access to the identiﬁable data will be required to undergo annual responsible conduct of research, 
cybersecurity, and HIPAA certiﬁcation in accordance with University of Pennsylvania regulations. All 
data for this project will be stored on the secure/ﬁrewalled servers of the PMACS Data Center, in data 
ﬁles that will be protected by multiple password layers. These data servers are maintained in a guarded 
facility behind several locked doors, with very limited physical access rights. They are also cyber-
protected by extensive ﬁrewalls and multiple layers of communication encryption. Electronic access 
rights are carefully controlled by University of Pennsylvania system managers. We will use highly 
secure methods of data encryption for all transactions involving participants ﬁnancial information using 
a level of security comparable to what is used in commercial ﬁnancial transactions. We believe this 
multi-layer system of data security, identical to the system protecting the University of Pennsylvania 

Page 19
Health Systems medical records, greatly minimizes the risk of loss of privacy. Each subject will be 
assigned a unique identiﬁer without identifying information, and data will be entered into an electronic 
database using only the unique identiﬁer. Only trained study staff will have access to the code that links 
the unique identiﬁer to the subjects identity. Electronic data will be stored on secure, password-
protected ﬁrewalled servers at the University of Pennsylvania. The OneTouch Reveal® web app is a 
diabetes management tool that can help you track your blood sugar from your compatible iOS or 
Android wireless device and easily share your readings with your healthcare professional and family 
members. Participants will only have a numeric study ID entered into the application, so there is no risk 
of loss of conﬁdentiality or personal information.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? [NOTE: This does not apply to: 1) research information that would 
not normally be included in the electronic medical record or 2) information that is in the electronic 
medical record as part of clinical care.]
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
Study personnel will interview patients in designated private rooms in the clinic in order to explain the 
study and request informed consent. If informed consent is granted, all interviews will be performed in 
private settings. In the case of follow-up surveys, if the survey will take place over the phone, the RA 
will ensure that the patient has the privacy desires to conduct the interview. The study protocol will 
comply with the Final Privacy Rule of the Health Insurance Portability and Accountability Act. The 
research computing environment has a security component required due to HIPAA; federal, state, and 
research compliance regulations. During IMPaCT Intervention Activities: IMPaCT Partners will be 
trained extensively on protecting patient privacy. For instance, they will always ensure that patients are 
able and willing to speak privately over the phone or during home visits before beginning any 
conversation. Throughout the study, staff will safeguard participant privacy, only breaking 
conﬁdentiality in cases of 1) threat to harm self or others, 2) mandated reporting of child abuse or 
neglect. Interested participants will have their demographic characteristics entered into the Way to 
Health portal. Enrollment will include a description of the voluntary nature of participation, the study 
procedures, risks and potential beneﬁts in detail. The enrollment procedure will provide the opportunity 
for potential participants to ask questions and review the consent form information with family and 
friends prior to making a decision to participate. Participants will be told that they do not have to 
answer any questions if they do not wish and can drop out of the study at any time, without affecting 
their medical care or the cost of their care. They will be told that they may or may not beneﬁt directly 
from the study and that all information will be kept strictly conﬁdential, except as required by law. 
Subjects will be given a copy of the consent document. All efforts will be made by study staff to ensure 
subject privacy.
Disclosures
Will any data or specimens from Penn participants OR other research generated work product (e.g., 
intellectual property) be disclosed to any individuals, entities, or vendors, etc. outside of Penn?
No

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Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
x Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
x Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
No
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
No
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
No
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 

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of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable
Consent
1. Consent Process
Overview
When interested patients arrive at the clinic, the CRC or RA will obtain their written informed consent. 
The trained recruiter will provide a detailed description of the voluntary nature of participation, study 
procedures, risks and potential beneﬁts. The potential participant will be provided the opportunity to 
ask questions and review the consent information with family and friends prior to making a decision to 
participate. Participants will be told that they do not have to answer any questions if they do not wish 
and can drop out of the study at any time, without affecting their medical care or the cost of their care, 
or that of their spouse of partner. They will be told that they may not beneﬁt directly from the study and 
that all information will be kept strictly conﬁdential, except as required by law. All participants will be 
given a copy of the signed informed consent form. For participants who are offered the opportunity to 
participate in a qualitative interview, and elect to do so, we will repeat the above procedures with an 
interview-speciﬁc additional consent document. Participants will have the opportunity to discuss the 
consent document with research personnel, and will be informed about the voluntary nature of 
participation in the interview. Participants will receive a signed copy of the additional consent 
documentation. We additionally have proposed to conduct qualitative interviews with the 2 Community 
Health Workers serving patients within this study. We will consent these Penn Medicine staff members 
using the attached consent form. Due to COVID-19 we have requested a waiver of written 
documentation of consent, due to the signiﬁcant challenges posed by obtaining documentation of 
consent given pandemic precautions limiting in-person visits, and the limited access to technology 
among our study population.
Children and Adolescents
Not applicable
Adult Subjects Not Competent to Give Consent
Competence will be assessed by the interviewer and we will exclude patients who cannot or will not 
give consent.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
Waiver of written documentation of informed consent: the research presents no more than minimal risk 
of harm to subjects and involves no procedures for which written consent is normally required outside 
of the research context
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No
If no written statement will be provided, please provide justiﬁciation
Due to the current COVID-19 pandemic, we are unable to meet study participants in-person, therefore 
prohibiting us from sharing a physical copy of the written statement of research. However, all 

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participants consenting to participate in qualitative interviews who were previously enrolled as 
participants in the Engage RCT were previously provided with a physical copy of the overall study 
consent form, which explains the overall goals of the research project, and refers to the qualitative 
interview process.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt
Potential Study Risks
A potential risk of this study is a breach of participant conﬁdentiality. We will minimize this risk by 
linking individual identifying information with participant ID numbers only in one single secure ﬁle. 
Due to the ﬁnancial incentives in this study, we will be collecting social security numbers so that we 
can complete W-9 forms for participants. Social security numbers only will be used to generate W-9 
forms and will be deleted once they are no longer needed. We will also collect home addresses to mail 
incentive payments. This will be done through a University of Pennsylvania approved partnership with 
Greenphire ClinCard. Accidental disclosure of social security numbers could lead to identity theft. We 
will use commercial-grade encryption to protect social security information in transit. Names and 
addresses will be stored in encrypted databases. These data will be viewable only by the respective 
participants and the study coordinator. All other members of the research team will be able to view only 
participant ID numbers. There will be no functionality in the web application to export a dataset with 
identiﬁable information. Even the study arms will be identiﬁed by code letters until both the statistician 
and PI agree that analysis is complete.
Potential Study Beneﬁts
Participants may beneﬁt by improving control of their diabetes through increased self-monitoring of 
their blood glucose level.
Alternatives to Participation (optional)
Data and Safety Monitoring
Data will be monitored by the Principle Investigator and other investigators throughout the data 
collection and analysis process. We will have an internal safety review that is blinded to arm and a 
quarterly discussion of adverse events. We will ask patients about any medical incidents and 
hospitalizations at the 3 and 6 month follow up visits and record their responses. A nurse practitioner 
will then determine if medical incidents and hospitalizations are study related. Study related events will 
be discussed with our internal DSMB.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt Assessment
There is a very low ratio of risk to beneﬁt in this study. There is minimal risk to participation in the 
study.
General Attachments
The following documents are currently attached to this item: