Diabetes Homeless Medication Support Single Arm Treatment Development Trial
Phase: NA
Conditions: Type 2 Diabetes, Homeless Persons
Sponsor: Hennepin Healthcare Research Institute

 
 
Diabetes Homelessness Medication Support Single Arm Treatment Development Trial 
 
NCT04678284 
 
July 20, 2021 
 

 
 
 
 
 
ii 
Title: 
Development of the Diabetes Homeless Support (D-Homes) Program 
– Part Two 
Drug or Device 
Name(s): 
Not applicable (N/A) 
FDA IND/IDE  
N/A 
Sponsor: 
The National Institute Of Diabetes And Digestive And Kidney 
Diseases of the National Institutes of Health under Award Number 
K23DK118117 
Protocol Date: 
Revision Date(s): 
Friday, November 13, 2020 
12/29/2020, 3/8/2021, 4/1/2021, 6/16/2021, 7/20/2021 
 
Study Principal Investigator: 
Katherine Diaz Vickery, MD, MSc 
701 Park Ave., S2.300 
Minneapolis, MN, 55415 
Phone: 612-873-6852 
email: katherine.vickery@hcmed.org 
 
Other Investigators: 
Andrew Busch, PhD 
Mark Linzer, MD 
John Connett, PhD 
Victor Montori, MD 
Lillian Gelberg, MD, MSPH 

 
1 
TABLE OF CONTENTS 
Protocol Synopsis ................................................................................................................................ iv 
Table 1: Schedule of Study Procedures ........................................................................................ vii 
2 
Background Information and Rationale ............................................................................... 1 
3 
Study Objectives .......................................................................................................................... 4 
4 
Investigational plan .................................................................................................................... 4 
5 
Study Procedures ........................................................................................................................ 6 
6 
Study Evaluations and Measurements ................................................................................. 11 
7 
Statistical Considerations ........................................................................................................ 14 
8 
Study Medication (Not applicable) ........................................................................................ 16 
9     Study Administration ................................................................................................................ 17 
10 References ...................................................................................................................................... 22 
11 Appendix ........................................................................................................................................ 28 
 
 
 

 
PROTOCOL SYNOPSIS 
Study Title 
Development of the Diabetes Homeless Support (D-Homes) 
Program – Part Two 
Funder 
NIH-NIDDK 
Clinical Phase 
N/A 
Study Rationale 
More than eight million Americans each year experience unstable 
housing and/or homelessness; this includes 44% of all adults seen at 
community health centers. The chronically homeless have a 5- to 
10-fold increased risk of premature death and high health care costs 
(driven by acute emergency department and hospital visits). 
Diabetes prevalence is approximately the same among the homeless 
versus general population (8%), but people with type 2 Diabetes 
who experience Homelessness, herein abbreviated as DH, have 
worse glycemic control and are hospitalized for diabetes 
complications a decade earlier and with more frequency than their 
housed peers. Most DH are of minority race and/or ethnicity. Poor 
glycemic control can induce “metabolic memory,” or long-term 
vascular stresses which persist despite later glucose normalization. 
Managing diabetes while homeless presents a unique set of barriers 
including food insecurity, low social support, lack of safe 
medication storage/refrigeration. Almost half of people who are 
homeless have comorbid mental illness and/or substance use 
disorders. Prescription medications are a cornerstone in the 
management of type 2 diabetes and avoidance of complications. 
Diabetes medication adherence is low in housed populations, and 
limited evidence suggests it is as low or lower among DH; 
adherence is highly correlated with all-cause hospitalization and 
mortality. A tailored intervention to improve medication adherence 
in DH could have substantial public health impact through reduction 
of the disparities in morbidity and mortality faced by DH. 
The study goal is to develop and pilot test a collaborative care 
intervention tailored to DH using motivational interviewing and 
psychosocial support to improve medication adherence. Our 
team’s central hypothesis is that medication adherence (and eventual 
glycemic control, health care use/cost) will improve with an 
intervention tailored to the unique context of DH. 
Study Objective(s) 
Primary  
• To develop and pilot test a behavioral intervention tailored to 
DH using behavioral activation, motivational interviewing and 
psychosocial support to improve medication adherence 
Secondary 
• 
To improve diabetes control (HgA1c)  
Test Article(s) 
Behavioral intervention to support medication adherence 

 
Study Design 
Single arm treatment-development trial 
Subject Population 
Key Criteria for 
Inclusion and Exclusion: 
We will enroll adults (age > 18 yrs.) with type 2 diabetes who are 
experiencing homelessness. 
Inclusion criteria: 
1. Age 18 yrs. or older 
2. English-speaking 
3. Homelessness by federal definition in the last 12 mo. 
4. Self-reported diagnosis of type 2 diabetes, later verified in 
medical record 
5. Plan to stay in local area or be reachable by phone for the 
next 16 weeks 
6. Willingness to work on medication adherence and diabetes 
self-care 
Exclusion criteria: 
1. Inability to provide informed consent (e.g., presence of a 
legal guardian, prisoners) 
2. Active psychosis or intoxication precluding ability to give 
informed consent 
3. Pregnant or lactating females.  
4.   Patients who choose to opt out of research. 
Number Of Subjects  
 
Total Number of Subjects: 15 
Total Number at Hennepin Healthcare: Unknown  
Total Number of Sites: 1 (Health Care for the Homeless) 
Study Duration 
Each subject’s participation will last 16 weeks. 
The entire study is expected to last one year. 
Study Phases 
Screening 
Intervention 
Follow-Up   
(1) Screening: screening for eligibility and obtaining consent, 
baseline assessment  
(2) Intervention: study intervention with counselor support 
approximately weekly in-person and/or by phone x 12 weeks 
(3) Follow-up: final assessment 
Efficacy Evaluations 
• Self-reported medication adherence 
• Self-reported psychological wellness 
• Self-reported diabetes self-management, distress  
• Hemoglobin A1c measured by point-of-care fingerstick 
Safety Evaluations 
Not applicable in this single arm trial 
Statistical And Analytic 
Plan 
The primary endpoint of this study is the feasibility and 
acceptability of the program to participants in this treatment 
development phase. We will summarize themes in the end-of 
treatment interview, assess satisfaction via structured survey, and 

 
assess treatment dose received via frequency, length, and type of 
communications with study staff. 
We will conduct exploratory analyses on our eventual primary 
behavioral endpoint of medication adherence and compare this with 
change in our eventual primary clinical endpoint of point-of-care 
Hemoglobin A1c during this same time frame. We will refine our 
use of patient-reported outcomes and administrative claims data for 
use in the future, planned randomized pilot trial. 
Data And Safety 
Monitoring Plan 
Dr. Vickery (PI) will work closely with study staff to monitor the 
quality of data collected at assessment. This treatment development 
study (N=15), does not meet NIH criteria requiring a Data Safety 
Monitoring Board (DSMB), however Drs. Vickery, Busch, and 
Connett will oversee a detailed safety monitoring plan. 

 
vii  
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
Study Phase 
Eligibility 
screening 
Consent, 
Baseline 
visit 1 
Run-in, 
Baseline 
visit 2 
Treatment sessions 
 
Follow-up 
visit 
 
Visit Number 
 
 
 
1 
2 3 
4 
5 
6 
7  
8 
9 
10 
 
Study Weeks 
0 
1 
2-3 
2-3 
4 5 
6 
7 
8 
9 
10 
11 
12 
13-16 
Confirm communication preferences 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
Review Inclusion/Exclusion Criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics/Medical History 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical records request/abstraction 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Vital Signs: BP, HR 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Height and Weight 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Hemoglobin A1c 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Medication review 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Self-report survey measures 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
Satisfaction with intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 

 
  1 
2 
BACKGROUND INFORMATION AND RATIONALE 
OVERVIEW 
This protocol is part 2 of a set of studies with an overall goal to develop and pilot test a 
collaborative care intervention using motivational interviewing and behavioral activation alongside 
education and psychosocial support to improve medication adherence tailored to the experiences of 
people experiencing homelessness and diabetes (DH). Our team’s central hypothesis is that 
medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) 
will improve with an intervention tailored to the unique context of DH.  
 
This work builds upon part 1 (HSR#19-4622) during which we completed Aim 1 activities to 
develop the initial Diabetes Homeless Medication Support (D-Homes) treatment manual through 
focus groups with DH at various levels of glycemic control and interviews with their multi-
disciplinary providers. Data from this phase has identified barriers and strategies for medication 
adherence, patient values regarding medication, and treatment preferences and informed 
development of this part 2 application.  
 
This protocol addresses Aim 2, to test patient perceptions of the feasibility and acceptability of study 
procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis 
that the D-Homes manual and study procedures will be feasible and acceptable to DH as measured 
by self-report and post-treatment interview. 
 
Eventually, part 2 will be followed by a fully randomized pilot study in concordance with study Aim 
3, a fully randomized pilot trial. Approval of this activity from the IRB will be sought before these 
activities begin. 
 
SIGNFICANCE 
Homeless people in the US face disproportionate risk for premature death in part 
due to poorly controlled chronic diseases including diabetes. One and a half million 
unique US adults access homeless shelters annually. However, the total number of people 
experiencing homelessness (Box) is likely much higher19 with an estimated 7 million 
additional people living “doubled up” with family/friends in 2014.20 New data recently 
established that 44% of all adults, and 37% of adults with diabetes, at US community health 
centers experience unstable housing.3,4 All-cause mortality rates among people experiencing 
homelessness in the U.S. are 4.5 to 9.6-times higher than the general population. Premature 
death often results from preventable chronic 
diseases including diabetes (2%) and its related 
comorbidities, e.g. heart disease (16%).21 
While diabetes prevalence among the 
homeless and general population is comparable 
(≈8% in both),22 there is evidence indicating 
large disparities in diabetes outcomes. Patients with type 2 Diabetes who are Homeless, 
herein abbreviated DH, have worse glycemic control23 and are hospitalized for diabetes-
related complications a decade earlier than their housed peers.24 New data finds unstably 
housed adults have over five times the odds of diabetes-related emergency or hospital visit.4 
This is of particular concern given “metabolic memory,” or long-term vascular stresses 
which persist after significant early hyperglycemia despite later glucose 
normalization.25 While homelessness and unstable housing are increasingly recognized for 
Box. Defining Homelessness:
Many definitions of homelessness exist. We adopt that 
of the U.S. government which includes people who:
•
Lack “fixed, regular, adequate nighttime residence”
•
Stay at emergency shelters, temporary living 
facilities, other places not meant for human habitation
•
Will imminently lose their primary residence 
(HEARTH Act, 2011)

 
  2 
their impact on diabetes control, including by the American Diabetes Association,26,27 there 
is a paucity of solution-driven research. Thus, there is an urgent need to develop novel 
treatments to improve glycemic control in DH as they move across the spectrum of unstable 
housing.   
Medication adherence is a complex behavior critically linked to improved overall 
and diabetes-specific outcomes. The rate of adherence for all long-term therapies 
averages 50% in the general (non-homeless) U.S. population due to barriers at various 
levels including: (i) patient, (ii) medication/disease, (iii) system, and (iv) socioeconomic.28 
Among privately insured populations, non-adherence to diabetes and related cardiovascular 
medications is associated with poor disease control (e.g., higher hemoglobin A1c and blood 
pressure), as well as increased risk of all-cause mortality and visits to the hospital and 
emergency department, and total health care costs.29,30 In low-income populations, cost-
related non-adherence is common,31 and non-adherence is correlated with poor glycemic 
control.32 In fact, every 10% improvement in diabetes medication adherence reduced 
hemoglobin A1c by 0.16%.33 The importance of medication adherence is recognized by NIH 
with an active FOA to improve medication adherence (PA-18-722).34  
Poor diabetes outcomes among the homeless is caused by low medication adherence. 
Non-adherence to medications across disease types is a known concern for homeless people 
especially when they are young (age <40 yrs.), have comorbid mental health/substance use 
disorders, experience food insecurity35 and frequent the emergency department. Despite high 
rates of overlapping physical and behavioral co-morbidities,36 36% of US homeless adults 
report unmet needs for prescription medications.37 Small studies find lower medication 
adherence in homeless patients when directly compared to housed peers.38 DH patients 
specifically report challenges obtaining, storing, and retaining medication (especially 
insulin), and stigma surrounding the possession/use of needles.39,40,41,42  
Existing evidence-based models targeting medication adherence to improve diabetes will be 
the starting point for our novel intervention. We will draw from such interventions which target 
patient and system-level factors43 to improve diabetes self-care activities, including medication 
adherence, for historically disadvantaged groups. The overarching theoretical model guiding 
treatment development is the Information Motivation Behavioral Skills model.44 Our proposed 
treatment is also consistent with the Collaborative Care Model, a care management approach 
designed for individuals with multiple chronic conditions with known success improving diabetes 
outcomes in patients with depression.45,46 The Collaborative Care Model frequently uses 
Motivational Interviewing as the counseling approach, as we plan to in this study.47 Behavioral 
Activation (BA) is another counseling approach that complements motivational interviewing. 
Behavioral intervention is empirically supported to address medication adherence in a population 
with high levels of underlying psychiatric disease (especially depression) and/or psychosocial 
stress.96-99 BA is easier to train than other empirically-supported counseling treatments and can be 
delivered with fidelity by bachelor’s level practitioners.100-101 BA is appropriately complemented by 
motivational interviewing, a person-centered, evidence-based approach to behavior change focused 
on participants’ values and preferences and overcoming expected ambivalence to change.48 It is 
particularly appealing to groups with historic disadvantage and minority race,48 including the 
homeless,49 and has improved medication adherence in non-homeless people with diabetes50,51 
including when delivered by trained, non-mental health professionals to low-income populations.52 
We will use BA first and employ MI when participants demonstrate ambivalence to change.  
We will also integrate education using content consistent with the latest diabetes care guidelines.26  
And we will offer problem-solving to address psychosocial needs (including food and housing) 
modeled after clinic-based approaches for homeless veterans.53,54 These evidence-based interventions 

 
  3 
offer a starting point for a new intervention which will be tailored to the unique context of DH 
through the iterative, multi-stakeholder process described below.  
2.1 
Name and Description of Intervention 
The behavioral intervention tested in this protocol is the Diabetes-HOmEless Medication 
Support (D-HOMES) program. This will be a 12-week in-person, video, and/or phone-based 
support program centered on providing diabetes education, motivational and goal-setting 
support, and resource and care coordination (Figure 2). Psychological approaches of 
behavioral activation and motivational interviewing will be used along with provision of 
educational materials and tools to support behavior change, see Section 3. for details.  
  
2.2 
Selection of Treatment Dosages 
Treatment doses are similar to a multiple health behavior change intervention currently 
underway by Dr. Andrew Busch (“Development of an Integrated Depression and Behavioral Risk 
Factor Reduction Intervention for Secondary Prevention following Acute Coronary Syndrome,” 
1R03HL136540), primary mentor on this study. This is also in line with current literature 
about behavioral interventions to support improved diabetes self-management via 
medication adherence and psychosocial wellness.94 During this treatment development 
phase we will monitor and adjust the number and duration of planned sessions based on the 
data from case study participants. This will inform Aim 3 randomized pilot future steps. 
 
2.3 
Relevant References See Section 10 for References. 
2.4 
Compliance Statement 
This study will be conducted in full accordance of all applicable Hennepin Healthcare 
Research Policies and Procedures and all applicable Federal and State laws and regulations. 
All episodes of noncompliance will be documented and reported according to the Prompt 
Reporting Guidelines, Attachment EEE, of the Hennepin Healthcare IRB Policies and 
Procedures. 
Figure 2. D-HOMES Treatment model 

 
  4 
The investigators will perform the study in accordance with this protocol, will obtain 
informed consent and will report unanticipated problems involving risks to subjects or 
others and SAEs in accordance with The Hennepin Healthcare IRB Policies and Procedures 
and all Federal requirements. Collection, recording, and reporting of data will be accurate 
and will ensure the privacy, health, and welfare of research subjects during and after the 
study.  
3 
STUDY OBJECTIVES 
The purpose of the study is to develop and pilot test a collaborative care intervention using 
motivational interviewing and behavioral activation alongside education and psychosocial 
support to improve medication adherence tailored to the experiences of people experiencing 
homelessness and diabetes (DH). 
3.1 
Primary Objective (or Aim) 
The primary objective of this study is to determine whether a 10-session behavioral 
activation and motivational interviewing support program is feasible and acceptable to DH. 
The outcomes we will use to assess this treatment development phase of our work will be 
our ability to recruit and retain participants, the dose of treatment we can deliver (i.e., 
participant’s attendance and follow-up with scheduled sessions and treatment activities), and 
participants’ report of their satisfaction and overall experience during participation in a 
structured survey and qualitative interview.  
3.2 
Secondary Objectives (or Aim) 
The secondary objectives will be to edit Aim 3 randomized pilot trial protocols and 
treatment manual instructions to optimally support participants. We will: 
Clarify recruitment and retention strategies for DH  
Assess the acceptability of patient-reported outcome measures and laboratory testing 
protocols  
Finalize plans to use administrative claims and health care record data 
Determine adequate incentive amounts and adequate timing of distribution 
Refine protocols for distribution of phones and other tools to support intervention 
participation and behavior change 
 
4 
INVESTIGATIONAL PLAN 
4.1 
General Schema of Study Design 
This is a single arm pilot trial to inform development of the D-HOMES behavioral 
treatment, see Table 1 above. The intervention, see Figure 1 above, targets diabetes 
education, motivation and goal-setting support, as well as resource and care coordination for 
people experiencing type 2 diabetes and homelessness (DH). The goal of this treatment 
development phase of our work is to refine approaches and protocols for further study of our 
program. 

 
  5 
4.1.1 Screening Phase and Baseline Assessment 
Recruitment protocols are summarized in section 9.5 below but will involve (1) invitation to 
aim 1 research participants who indicated interest in future research, and (2) referral from 
Health Care for the Homeless, Hennepin Healthcare, or shelter staff, (3) snowball sampling 
using advertisements and referrals via community partners and previous participants, (4) 
community advertisement using flyers in places such as bus stops, libraries, and shelters, 
and if needed (5) invitation letters and follow-up calls to eligible patients at Hennepin 
Healthcare, (6) tabling events with study flyers and snacks at Hennepin Healthcare or Health 
Care for the Homeless facilities and in public community spaces such as libraries, shelters, 
and community organizations. 
Potential subjects will be screened by phone using the protocol inclusion and exclusion 
criteria. See Appendix A. 
Congruent with other trials in this area,49 we will conduct a 2-week run-in period to ensure 
participants are able to follow-up. During this time two baseline assessment visits will be 
scheduled. The second baseline assessment visit will be scheduled to correspond to the first 
treatment visit whenever possible.  
4.1.2 Study Intervention 
This study will be offered to willing participants as an adjunctive to usual diabetes care. 
During the screening and run-in period, participants will be encouraged and supported to 
continue seeing their regular health care team. If they do not have one, support will be given 
to help the participant schedule a primary care or endocrinology appointment at Hennepin 
County Health Care for the Homeless, Hennepin Healthcare, or another clinic/health system 
per participant preference. 
4.1.3 Follow-up  
To be eligible for follow-up, subjects must either have completed their planned coaching 
sessions or requested to end their coaching sessions early. Since the emphasis of this 
treatment development study is feasibility and acceptability, those ending early will be given 
particular attention so that their insights and experiences can shape future adaptations to the 
intervention and study design. 
4.2 
Allocation to Groups and Blinding Not applicable to this phase of the study. 
4.3 
Study Duration, Enrollment and Number of Sites 
4.3.1 Duration of Study Participation 
Participants will be screened and recruited for a 2 week run-in period. They will engage in 
10 weekly sessions over 12-weeks with our interventionist (“diabetes wellness coach”), and 
they will have a 4 week period within which to complete any missed visits and their final 
assessment visit. This is a maximum of 16 weeks duration per participant.  
4.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
Enrollment for the study will continue until 15 participants have been recruited or when 
enough data has been gathered to inform future steps of treatment development. 
HHRI will serve as the only site for this study. Health Care for the Homeless will offer 
space in the community for study related activities to minimize burden on participants (See 
Appendix B for letter of support with addresses list). 

 
  6 
4.4 
Study Population 
4.4.1 Use of Vulnerable Populations and Patients Who Opt Out of Research 
This study focuses on adults experiencing type 2 diabetes and homelessness. This is justified 
given the premature morbidity and mortality of this population from diabetes and related 
comorbidities. While not formally considered a vulnerable population, DH are a population 
requiring special attention with regard to safety and respectful engagement in research. 
A consent quiz will be used to ensure that no individuals unable to consent are recruited 
similar to protocols used in part 1 of this study (HSR#19-4622). See Appendix C. 
Furthermore, we will continue working closely with community providers in this area and a 
multi-stakeholder team to ensure we achieve cultural congruence with the ways we approach 
and engage this population in research as well as with the planned study protocols.  
No patients who have chosen to opt out of research will be included in this study. 
4.5 
Inclusion and Exclusion Criteria 
4.5.1   Inclusion Criteria 
Inclusion criteria: 
1. Age 18 yrs. or older 
2. English-speaking 
3. Homelessness by federal definition in the last 12 mo. 
4. Self-reported diagnosis of type 2 diabetes, later verified in medical record 
5. Plan to stay in local area or be reachable by phone for the next 16 weeks 
6. Willingness to work on medication adherence and diabetes self-care 
 
4.5.2   Exclusion Criteria 
1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 
2. Active psychosis or intoxication precluding ability to give informed consent 
3. Pregnant or lactating females.  
4. Patients who choose to opt out of research. 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
5 
STUDY PROCEDURES 
5.1 
Qualifying Visit 
 
5.1.1 Eligibility, screening visit 
As outlined in Table 1, before consent, interested participants will complete a phone 
screening. This will cover inclusion and exclusion criteria and briefly describe the 
intervention to ensure the participant is aware and willing to commit to study. 
5.1.2  Baseline Assessment and run-in 
After the screening visit, after the participant’s signed consent at baseline assessment visit 1, 
the medical record will be accessed. Participants’ diabetes diagnosis, past 12 mo. HgA1c, 

 
  7 
medication list, frequency of refills, primary care team, and pattern of clinic/emergency 
department/hospital visits will be abstracted and recorded for the previous 12 mos.. If 
patients are found not to have diabetes at this point, they will be excluded from the study. 
 
If patients are confirmed to be eligible based on medical record review, we will proceed 
with baseline visit 2. This will be an in-person visit scheduled to correspond with study visit 
#1.  
 
As outlined in Table 1 above, the screening visit and baseline assessment visits will collect: 
• Informed Consent, HIPPA authorization 
• Review Inclusion/Exclusion Criteria 
• Demographics/Medical History 
• Release of information for health systems used in last 12 mo.  
• Release of information for insurance claims data in the last 12 mo.  
• Vital Signs: BP, HR 
• Height and Weight 
• Point of care Hemoglobin A1c (HgA1c) 
• Medication review, self-reported and later verified in EHR 
• Primary/diabetes care team review 
• Patient-reported outcome survey items: 
o Health-related Quality of Life (EQ-5)102 
o Kessler K-6 measure of psychological distress103 
o Mental Health Inventory (MHI-5)115 
o Health-related Quality of Life Short Form (SF-12)116 
o Diabetes Distress Scale (17-items)104 
o Problem Areas in Diabetes (PAID)113 
o Illness Intrusiveness Scale112 
o Treatment Burden questionnaire114 
o Diabetes self-management questionnaire (DSMQ)105 
o Adherence to Refills and Medications Scales-Diabetes (ARMS-D)111 
o Self-reported medication adherence (Adherence Start with Knowledge, 
ASK-12)106 
o Basic needs survey107 
o Current and lifetime housing status 
o Use of substances 
o Brief Trauma Questionnaire108 
o Self-reported health care use 
Since a goal of this treatment development trial is to refine both the flow of the initial 
baseline assessment visits as well as which patient-reported instruments are best tolerated, 
not all participants will receive all survey items. Informed consent and HIPAA authorization 
will always be collected at baseline assessment visit 1. However, we will adjust when other 
data are collected across the first two baseline visits based on participant and assessment 
surveyor feedback.  

 
  8 
 
5.2 
Study Intervention  
This will be a 10 session, 12-week in-person, video, and/or phone-based support program 
with assessment for 2 weeks before and 2 weeks after treatment visits. The treatment will 
center on providing diabetes education, motivational and goal-setting support, and resource 
and care coordination (Figure 2). Modality of treatment delivery will be adapted based on 
logistics by study team considering participant preference as well as safety with regard to 
the COVID-19 pandemic.  
In-person assessment visits will be conducted within Health Care for the Homeless clinical 
spaces at sites convenient to participants (see Appendix B for letter of support including 
addresses of sites) or at HHRI/HHS.  
All in-person assessment and treatment visits will follow current guidance from HHRI and 
Hennepin Healthcare about social distancing and use of personal protective equipment. 
In-person treatment visits will be arranged at private spaces convenient to the participant 
that may include the participants home (see Appendix D for safety protocol related to home 
visits).  
Video visits will be conducted via a secure Zoom or Teams link (using HHRI, Hennepin 
Healthcare, and/or Hennepin County HIPPA secure technology). Health Care for the 
Homeless maintains private spaces within local shelters and drop-in centers. They also have 
secure tablets on rolling stands for telehealth use in shelter clinics and hotels. These will be 
used for assessment and treatment visits in cooperation with HCH staff. If needed, an HHRI 
supported tablet may be added to further facilitate video visits. This may take place in 
adjacent, private rooms at a shelter, hotel, or apartment facility (e.g. participant in their own 
room or in a clinic exam room and research staff in a private office or exam room) or may 
be conducted by dropping off a tablet for participant use and collected later. See Appendix E 
for Study Issued Cell Phone/Tablet Agreement. 
Phone visits will be conducted via a study or office phone or using the secure TelemedIQ 
app of study team members. If phone minute compensation below is insufficient to support 
participant phone access or a participant mentions they have no working phone, a study 
phone will be issued to participants. Participants receiving a phone will sign a Study Issued 
Cell Phone/Tablet Agreement (See Appendix E). 
Psychological approaches of behavioral activation and motivational interviewing will be 
used along with provision of educational materials and tools to support behavior change. 
Tools/materials will be distributed with travel and cell phone minute renumerations as 
above. See Appendix F for a sample list of tools and educational materials that might be 
provided. Which tools and educational materials are given to which participants will be 
decided by the coach depending on participant need as well as the specific goals that are 
mutually set. E.g.) A participant with 10 medications per day may benefit from a pillbox 
with AM and PM slots. E.g.) A participant with many appointments for behavioral and 
physical health care may benefit from a pocket calendar. Financial value of gifts ranges from 
$2.99 (hand sanitzer) to $32.95 (lock boxes).  
In order to facilitate follow-up with this population, we will ask participants to provide 
multiple modalities by which we may contact them, including phone, email, and social 
media. 
While study visits may occur by phone, email and social media communications will be 
limited to content only related to arranging details of when/where and how to connect with 

 
  9 
participants. This may involve coordinating details to give a participant a study phone. This 
is necessary since we anticipate participants will have a higher than average likelihood of 
their phone service ending due to unpaid bills. If phone service is shut off, email and social 
media platforms continue to be used by participants through the phone’s wifi capabilities. 
Participants will provide their email addresses, usernames and preferred platforms and 
provide signed consent to be contacted in these ways. Privacy concerns and appropriate use 
of email and social media to arrange for other communication with study team will be noted 
in the consent. 
We will also ask participants to identify two people who know them well and would know 
how to reach them in the event that we are not able to contact them by phone, email, or 
social media. Similarly, we will ask participants to identify medical and social service 
providers who would know their current address or have up-to-date contact information for 
them. Participants will be asked to sign appropriate releases of information to allow medical 
and social service providers to share this information with the study team. 
5.2.1 Visit 1 
The first visit will immediately follow the baseline #2 visit and be conducted in person 
whenever possible. The goals of the first visit are to (a) establish rapport, (b) assess baseline 
diabetes self-care behaviors, (c) describe the rationale for the treatment. The interventionist 
will get to know the participant and discuss things of importance in their life. She will 
complete a detailed assessment of prescribed diabetes medications and use of pharmacies 
and health care clinics/hospitals supplementing with data from the medical record as needed. 
The interventionist will also: 
• Review boundaries for sessions, confidentiality, and mandated reporting 
• Educate the patient on the rationale of behavioral activation and motivational 
interviewing 
• Assess co-morbidities (e.g. mental illness, substance use disorder, heart disease) 
and contextual factors (e.g. housing status, social supports, food security) of 
influence 
• Assess existing diabetes care team; refer to HCH or Hennepin Healthcare if no 
team in place. 
• Assign self-monitoring goals per behavioral activation 
5.2.2 Visit 2  
The goals of the second visit are to complete a values assessment and provide 
relevant/needed health behavior tools. The interventionist will use a list to prompt the values 
assessment based on the Valued Living Questionnaire.96 She will: 
• Identify participant values 
• Provide health behavior tools as desired/needed (e.g., pill boxes, warm socks; see 
Appendix F for details) 
• Identify valued activities goals to promote diabetes medication adherence and 
psychosocial wellness specific to the participant’s values and context 
• Problem solve foreseeable barriers to behavior change goals 

 
  10 
5.2.3 Visits 3-5  
The goals of visits 3-5 will be to advance the practice of behavioral activation and 
motivational interviewing to promote improved diabetes knowledge/confidence, and 
reduced logistical and emotional barriers specifically related to medication and other 
diabetes adherence. During these visits the interventionist will: 
• Review engagement in health and wellness-promoting valued activities 
• Identify valued activities goals to promote diabetes medication adherence and 
psychosocial wellness specific to the participant’s values and context 
• Problem solve foreseeable barriers to emergent behavior change  
• Assess for inclusion of diet, exercise goals to enhance diabetes adherence goals 
5.2.4 Visits 6-8 
The goals of visits 6-8 are to continue to support behavior change related to diabetes 
medication adherence. During these visits the interventionist will:  
• Introduce advanced or challenging valued activity goals 
• Explore ways to increase synergy between psychosocial wellness and diabetes 
health behavior goals 
5.2.5 Visits 9-10 
The goals of visits 9-10 are to emphasize maintenance of behavior change achieved during 
earlier weeks and plan for sustainability. During these visits the interventionist will: 
• Plan and implement strategies for long-term maintenance of diabetes adherence 
goals 
5.2.6 Final Assessment 
The final assessment visit will be completed within 4 weeks of completion of visit 10 or 
upon early termination. This will be completed by a research staff member who is distinct 
from the interventionist. The staff person will assess: 
• Vital Signs: BP, HR 
• Height and Weight 
• Hemoglobin A1c 
• Medication review 
• Self-report survey measures 
• Satisfaction with intervention 
5.3 
Part 2 of the Study Details of Part 2 of the study (Aim 3 randomized trial protocols) 
will be submitted in a future amendment. 
5.4 
Unscheduled Visits 
Contact between the study team and participant during the 16 week intervention period will 
be encouraged. This will include reminders of study-related assessments and visits. The 
interventionist will work with the patient to set treatment goals related to improved diabetes 
care. These may include between-visit text messages, calls, e-mails, or private messages on 

 
  11 
secure social media platforms per the participant’s preference. These will be done with input 
and agreement by the participant. The interventionist will also respond to participant-
initiated between visit communications. Should communications become too frequent or 
surpass agreed upon treatment boundaries, the interventionist will be guided to set 
boundaries and limit contact by Drs. Vickery and/or Busch.  
5.5 
Concomitant Treatment 
All prior and concomitant diabetes care in the year prior to the screening visit and through 
the end of the study will be recorded with patient input as well as review of medical records 
(with signed consent). Care for relevant co-morbidities (mental illness, substance use 
disorder, cardiac disease, etc.) will also be recorded.  
5.6 
Rescue Medication Administration  Not applicable in this behavioral trial. 
5.7 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study treatment or visit schedules and AEs. If the Investigator becomes aware 
of any serious, related adverse events after the subject completes or withdraws from the 
study, they will be recorded in the source documents and on the case report form. 
5.7.1 Early Termination Study Visit  
Any participant who withdraws will have no further study visits.  
6 
STUDY EVALUATIONS AND MEASUREMENTS 
6.1 
Screening and Monitoring Evaluations and Measurements 
Our pre-consent phone screening will closely parallel the phone screening we completed for 
focus group participants in our Aim 1 study (HSR#19-4622). This was efficient and well-
tolerated by participants in a variety of housing circumstances in that study. The primary 
goal will be to ensure eligibility and interest in study participation. We will also ensure 
participant will be reachable for the 16 week study time frame. We will assess diabetes 
history, housing history, medication use, communication preferences/access, and also collect 
basic demographic data, (e.g. age, gender). See Appendix A for script and question 
structure. 
During the baseline and final assessment visits data will be collected using the following 
procedures: 
Demographics/Medical History 
Participants will be given a written survey at either the 
Baseline 1 or Baseline 2 visit to add to data collected in 
pre-consent screening. If patients prefer, these questions 
will be asked verbally by the assessor. 
 
Topics will include: health insurance, education, medical 
history, and current living situation. This will also include 
the Brief Trauma Questionnaire.108 
Medical record request/abstraction 
Signed release of information forms will be collected for 
participants at their primary care clinic/preferred health 
system and at Hennepin Healthcare and Hennepin County 

 
  12 
affiliate clinics (including Health Care for the Homeless). 
Once signed consent is obtained, EPIC records at 
Hennepin Healthcare will be directly accessed for 
abstraction with signed consent. 
 
Release of information (ROI) forms will be collected for 
outside health systems patients have used. ROI forms will 
be sent, via secure e-mail or fax, to Health Information 
Management offices at outside health systems. Return of 
information will occur via secure file transfer system 
preferred by the recipient organization.  
 
Returned records will be abstracted by study staff. 
 
After the Baseline 1 visit, we will abstract the past 12 mo. 
of: 
• 
Medication list, dose, frequency, and prescriber 
• 
Comorbidities (including physical and behavioral 
health) 
• 
History of medication refill frequency 
• 
Number of visits to primary care: Overall and related 
to diabetes  
• 
Number of visits and length of stay in the hospital: 
Overall and related to diabetes  
• 
Number of visits to the emergency department: 
Overall and related to diabetes  
• 
Number of visits to behavioral health providers, as 
relevant 
• 
History of hemoglobin A1c: Data and results of tests 
• 
History of blood pressure, height, and weight 
 
After the 12-week visit, we will review and abstract any 
changes in:  
• 
Medication list, dose, frequency, and prescriber 
• 
History of medication refill frequency 
• 
Number of visits to primary care: Overall and related 
to diabetes  
• 
Number of visits and length of stay in the hospital: 
Overall and related to diabetes  
• 
Number of visits to the emergency department: 
Overall and related to diabetes  
• 
Number of visits to behavioral health providers, as 
relevant 
• 
History of hemoglobin A1c: Data and results of tests 

 
  13 
Insurance company claims data 
During this case study phase of the project, we will refine 
our procedures for obtaining and formulating insurance 
company claims data. 
 
We expect most records to be from Minnesota Medical 
Assistance. We will work directly with Minnesota 
Department of Human Services Medicaid office to 
securely obtain records at the end of the study on all 
participants. Signed consents will be sent via secure fax or 
secure file transfer process.  
 
Pharmacy and health care claims data detailing medication 
refill patterns as well as clinic, hospital, and emergency 
department use across all health systems will be 
abstracted. We will follow pre-established protocols to 
examine hospitalizations for hyper and hypoglycemia.109  
Biometric data 
The following biometric data will be collected from 
participants. See Appendix G for detailed information on 
how these will be measured: 
• 
Blood pressure 
• 
Heart rate 
• 
Height 
• 
Weight 
• 
Hemoglobin A1c--Participants will receive a copy of 
their results. See Appendix H for A1c results sheet. 
 
Medication review 
Patients will be asked to bring all their medications to the 
Baseline 2 assessment visit. All dates, doses, frequencies, 
and prescriber information will be recorded. 
 
If patients forget, they will be asked to name this 
information and permission will be sought to confirm this 
within their medical record. 
Self-report survey measures 
Formal assessment surveys will be collected at Baseline 
Assessment 1 and/or Baseline Assessment 2 and 12-week 
assessment visits used as follows: 
1. Health-related Quality of Life (EQ-5)102 
2. Kessler K-6 measure of psychological 
distress103 
3. Mental Health Inventory (MHI-5)115 
4. Health-related Quality of Life Short Form 
(SF-12)116 
5. Diabetes Distress Scale (17-items)104 
6. Problem Areas in Diabetes (PAID)113 
7. Illness Intrusiveness Scale112 
8. Treatment Burden questionnaire114 

 
  14 
9. Diabetes self-management questionnaire 
(DSMQ)105 
10. Adherence to Refills and Medications Scales-
Diabetes (ARMS-D)111 
11. Self-reported medication adherence 
(Adherence Start with Knowledge, ASK-
12)106 
12. Basic needs survey107 
13. Current and lifetime housing status 
14. Use of substances 
15. Brief Trauma Questionnaire108 
16. Self-reported health care use 
Satisfaction with intervention 
At the final assessment visit, the assessor (who is not the 
interventionist) will collect input about the participant’s 
experiences during the intervention.  
 
Participant satisfaction will be assessed by the Client 
Satisfaction Questionnaire, an 8-item measure developed 
in the mental health field,95 and a qualitative interview 
focused on experiences during participation from 
screening through final assessment visit. See interview 
guide in Appendix I 
 
6.2 
Efficacy Evaluations 
Efficacy is not the intended goal of this treatment development study. However, eventually 
the goal will be to impact patient diabetes control as measured by Hemoglobin A1c. The 
primary behavioral target to achieve this impact will be medication adherence. Both of these 
endpoints will be measured, as detailed above, at the baseline and 12-week assessment visits 
during this single arm pilot.   
6.3 
Pharmacokinetic Evaluation Not applicable 
6.4 
Safety Evaluation 
Subject safety will be monitored by adverse events and rates of early termination of the 
study. We will also follow safety protocols in case we identify dangerous blood pressure, or 
heart rate values at baseline or final assessment visits. See Section 8 for details. 
7 
STATISTICAL CONSIDERATIONS 
7.1 
Primary Endpoint 
The primary endpoint of this study is the feasibility and acceptability of the program to 
participants in this treatment development phase. We will assess this by measuring our 
ability to recruit and retain participants, the dose of treatment we can deliver (i.e., 
participant’s attendance and follow-up with scheduled sessions and treatment activities), and 
participants’ report of their satisfaction and overall experience during participation in a 
structured survey (CSQ-8) and qualitative interview. In addition to above outcomes, we will 

 
  15 
carefully track the number and types of between-treatment communications with 
participants (who initiated communication; form of communication: text, calls, e-mails, 
etc.). 
We will conduct exploratory analyses to define our eventual primary behavioral endpoint of 
medication adherence e.g.) Change from baseline to 12-weeks in the ASK-12 questionnaire 
or Change from baseline to 12-weeks in ARMS-D questionnaire to help inform the next 
phase of the study. We will compare this with change in our eventual primary clinical 
endpoint of point-of-care Hemoglobin A1c during this same time frame. 
7.2 
Secondary Endpoints 
Secondary endpoints will include the following changes from baseline to 12-week visit: 
Overall change in patient-reported outcome measures: E.g.) Change in overall DSMQ score 
and changes in sub-scales E.g.) Change in Diabetes Distress score, E.g.) Change in health-
related quality of life and psychological distress 
Change in medication refill pattern from the electronic health record abstraction and 
insurance claims 
Change in blood pressure, BMI 
Safety and tolerability of the treatment based on Adverse Events and participant withdrawal 
Exploratory analyses will examine the impact of different algorithms on claims data variable 
specification to define medication adherence, health care use (clinic, hospital, and 
emergency department), as well as to categorize when use related to diabetes overall and 
specifically to hypo- and hyperglycemic events necessitating hospitalization. 
 
7.3 
Statistical Methods 
7.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
7.3.2 Efficacy Analysis 
The primary purpose of this study is feasibility and acceptability. This will be assessed using 
the following data: 
Qualitative data Analysis of audio recordings of end-of-treatment interviews will be 
completed by listening to files and taking detailed notes to highlight satisfaction, treatment 
experience, and suggested changes of intervention participants.  
Survey data from the Client Satisfaction Questionnaire (CSQ-8) will be summarized using 
descriptive statistics. Exploratory analyses by race, gender, and housing circumstances will 
be done to look for any patterns. 
Communication and treatment contact data will also be examined by creating summary 
counts of the number and types of communication (by modality and initiator), total minutes 
of completed treatment, and any notes from treatment sessions.   
Clinical outcome analyses will focus on exploratory analyses to determine any evidence as 
to whether D-HOMES had clinically meaningful effects. We will assess planned future 

 
  16 
primary behavioral and clinical outcomes of medication adherence (ASK-12) and point of 
care Hemoglobin A1c as detailed above. We will use t-tests to assess changes in these 
continuous variables in exploratory post-treatment analyses.  
We will additionally use chi-squared tests (for categorical variables) and t-tests (for 
continuous variables) to examine within participant effect sizes and response rates (using 
standard cut offs) on the secondary end points listed above. We will analyze data in an 
intent-to-treat manner. 
Exploratory analysis of electronic medical record and administrative claims data will 
examine the impact of various algorithms for constructing pharmacy-record adherence 
measures and health care use variables. We will use these analyses to define protocols for 
use in our Aim 3 randomized pilot. 
7.3.3 Pharmacokinetic Analysis Not applicable. 
7.3.4 Safety Analysis Not applicable since there is no control group in this study. 
7.4 
Sample Size and Power 
This sample size is appropriate for the goal of treatment development and protocol 
refinement. This is in line with ongoing studies by Dr. Busch (HSR#17-4351) as well as the 
current literature.110 
8 
STUDY MEDICATION (Not applicable) 
8  SAFETY MANAGEMENT 
8.1  Clinical Adverse Events 
Clinical adverse events (AEs) and serious adverse events (SAEs) will be closely monitored 
throughout the study in accordance with HHRI IRB definitions and policies.  
8.2  Adverse Event Reporting 
Unanticipated problems related to the research involving risks to subjects or others that 
occur during the course of this study and SAEs will be reported to the IRB in accordance 
with IRB Attachment EEE: Prompt Reporting Guidelines. AEs that are not serious but that 
are notable and could involve risks to subjects will be summarized and submitted to the IRB 
at the time of continuing review.  
Dr. Vickery will be responsible for completing Adverse Events Forms should an event 
occur. She will report Serious Adverse Events to the HHRI IRB within 24 hours of having 
received notice of the event.  
 
Drs. Vickery, Busch, and Connett will collaboratively gather any information needed to 
investigate the event and determine subsequent action. Any subsequent action will be 
documented and reported to the HHRI IRB and the Program Officer at NIH.  
 
Adverse event reports will be reviewed annually with the HHRI IRB to ensure participant 
safety. 
 
8.3  Investigator Reporting of a Serious Adverse Event to Sponsor 
Reporting to the National Institutes of Health will be completed as required by their policies 
or advised by HHRI IRB staff. 
8.4  Medical Emergencies 

 
  17 
If non-urgent psychological distress arises in participants during study related activities, 
study staff will provide a handout about local mental health resources, including a 24-hour 
support line and psychiatric emergency room (Appendix P). If non-urgent physical health 
needs arise in participants, study staff will provide written resources about health care 
available through Health Care for the Homeless and Hennepin Healthcare (Appendix P). 
If an emergency physical or behavioral health situation arises, study staff will arrange for 
immediate clinical support from PI (Dr. Vickery), Health Care for the Homeless clinical 
staff (who have a walk-in treatment model), the Hennepin County mental health crisis team 
(COPE Line, available by phone or in-person 24hrs./day, 7 days/week), or emergency 
medical services as appropriate. This event will be written up and reviewed by the PI (Dr. 
Vickery) and primary mentor (Dr. Busch) within 48 hours of the event and reported to the 
IRB if needed. 
If measured blood pressure surpasses SBP>180 or DBP>100 or pulse>150 or if blood sugar 
measurement takes place within a study visit and falls <60 or >400/error, study staff will 
page Dr. Vickery who will provide clinical assessment of symptoms and make referral or 
arrangement for immediate transfer to appropriate treatment as needed. 
As deemed necessary by the primary mentor and/or HHRI IRB, issues related to patient 
safety will be reviewed with mental health or medical professionals at HCMC not affiliated 
with the study who will provide recommendations for withdrawal from the study, referrals 
for additional care, or other necessary action.  
9  STUDY ADMINISTRATION 
9.1  TREATMENT ASSIGNMENT METHODS 
9.1.1  Randomization or Other Assignment No randomization will occur in this single 
arm trial. 
9.1.2  Blinding There will be no blinding. 
9.1.3  Unblinding Not applicable 
9.2  Data Collection and Management 
We will assign study ID numbers to all participants. Study IDs will be used on all study 
documents. Consent forms will be stored separately and will not be associated with study 
IDs when stored. Tracking forms will ensure each enrolled participant has a completed 
consent form.  
Data from paper surveys administered during screening interviews and assessment visits will 
be entered and stored in REDCap. Physical copies of the surveys will be stored in a locked 
file drawer separate from consent documents. Electronic health record access will take place 
in Hennepin Healthcare EPIC or via faxed paper copies of medical records from other health 
systems. Data from electronic health records will be extracted by a trained research staff 
member and entered into standard forms using REDCap. 
All treatment sessions and final close-out interviews will be audio recorded. Notes about 
treatment plans and notes summarizing main themes about satisfaction, treatment 
experience, and suggested changes will be created. Notes will remove all 18 HIPPA 
personal identifiers if mentioned. Notes will use only subject ID numbers and will contain 
no personal identifiers. Once audio recordings are uploaded to the HHRI-maintained 

 
  18 
computer network, they will be deleted from the audio recording equipment. Audio 
recordings will be destroyed on or before the end of the grant period, 12/31/2023.  
Since assessment visits will be conducted at locations away from the research offices of the 
PI, extreme care will be taken to keep study materials in the possession of research staff at 
all times. Immediately after visits, consent forms, hemoglobin A1c results, audio equipment, 
and other study materials will be returned to the secure research offices of Hennepin 
Healthcare Research Institute. Each office has a locked door in a badge-access-only wing of 
the Institute. Signed consent documents will further be stored in a locked file drawer whose 
key will be stored in a separate locked key box. 
Study data, including all audio recordings will be stored and analyzed on Dr. Vickery and 
her staff’s HHRI-maintained computer network. This network is robust, secure, and has 
state-of-the-art back-up and password protections. Dr. Vickery and staff will comply with 
any necessary software, hardware, and data storage updates to maintain the security of this 
system under the direction of the HHRI IT Department. 
The identifiers will be destroyed on or before the completion date of the grant, 12/31/2023.  
The other data will be retained for three years.   
9.3  Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
HHRI Institutional policies and HIPAA on subject privacy. The PI and other site personnel 
will not use such data and records for any purpose other than conducting the study.  
Confidentiality will be maintained by numerically coding all data, disguising identifying 
information, and keeping data in secure electronic locations or locked in file drawers. All 
electronic data will be numerically coded and stored on a password protected computer in a 
secure research space. All paper forms will be stored in locked file cabinets in a locked 
room. Names of participants will be stored separately. Participant information will be 
accessible only to HHRI-trained research staff, who are pledged to confidentiality and 
complete training in the ethical conduct of research (i.e., both HIPAA and CITI trainings). 
Identifying information will not be reported in any publication.   
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at Hennepin Healthcare) before sharing a limited 
dataset (PHI limited to dates and zip codes).  
9.4  Regulatory and Ethical Considerations 
9.4.1  Data and Safety Monitoring Plan 
This treatment development study (N=15), does not meet NIH criteria requiring a Data 
Safety Monitoring Board (DSMB) as we expect it to be considered minimal risk by the 
HHRI IRB.  
 
However, we have a detailed data safety and monitoring plan. Dr. Vickery will have primary 
responsibility for monitoring all procedures for data collection, analysis, and storage. Any 
adverse events, breaches of confidentiality, or other data or safety issues that arise will be 
discussed during weekly visits with Dr. Busch (primary mentor) or sooner if required and 
immediately brought to the attention of Dr. Connett (biostats. co-mentor). Dr. Connett has 
served on numerous DSMBs for large NIH trials. If needed, Drs. Busch and Connett will 
locate representatives independent of the study team for input. 

 
  19 
 
All issues related to patient safety (e.g., psychiatric distress) will be reviewed with medical 
and mental health professionals at Hennepin Healthcare not affiliated with the study who 
will provide recommendations for withdrawal from the study, referrals for additional care, 
or other necessary action. 
If requested by NIH or our local IRB, a DSMB will be convened. 
9.4.2  Risk Assessment 
Discomfort or distress when completing assessment and treatment procedures. Some 
participants may feel uncomfortable or distressed answering personal or private questions 
during assessment or treatment. Some participants may also feel uncomfortable or distressed 
due to the collection of physical measures (e.g., weight). In previous studies by Dr. Busch, 
when individuals did report discomfort in these situations, it was mild.  
We minimize discomfort or distress with three key approaches: (1) clearly explaining the 
study and emphasizing the optional nature of participation, (2) conducting all treatment 
sessions and assessment visits in private settings, (3) staff training about the sensitivity of 
chronic health conditions and the specific circumstances of homelessness including how to 
offer appropriate support. 
Confidentiality or loss of privacy. We will collect potentially sensitive information about 
participants; if released inappropriately, participants may experience embarrassment or 
distress. The seriousness of the consequences would depend on the nature of the information 
revealed and to whom the information was revealed. See Section 9.2 detailing the numerous 
steps we take to protect participant confidentiality. We therefore think the risk of a breach of 
confidentiality is low. 
Worsening of mental illness, depression, and emergent suicidality. Circumstances of 
homelessness can be high stress. Although there is no evidence to suggest this would be 
exacerbated from trial participation, it is possible that a minority of participants will 
experience worsening of mental illness, depression, or episodes of suicidality during this 
study. See Section 8.4 above for our detailed safety plan to address this risk. 
9.4.3  Potential Benefits of Trial Participation 
Potential benefits for participants include free diabetes management treatment with a goal of 
improved diabetes self-management which can reduce their morbidity from this disease. 
Free counseling related to psychosocial wellness may improve participants’ quality of life. 
Furthermore, there may be indirect benefits for participants in knowing they have helped 
promote research to develop an intervention that could help other people at later times.  
9.4.4  Risk-Benefit Assessment 
Overall, we expect the potential benefits to participants to outweigh the low risks of study 
participation. 
9.5  Recruitment Strategy 
Recruitment of participants will begin with subjects from part 1 (HSR#19-4622). In that 
study 21 of the 26 consented participants agreed to be contacted about future phases of this 
work. Participants provided their preferred contact information which will be used to invite 
them to participate. 
As a second approach, we will include additional recruitment via personal invitations by 
shelter and clinic staff who often have long-standing, trusted relationships with participants. 
We will also include staff at hotels where shelter clients with chronic disease have been 

 
  20 
relocated during the COVID-19 pandemic. We will provide flyers to these staff to share with 
eligible patients and/or to post in appropriate areas of their facilities. The flyer will include 
an email and phone number to invite interested patients to contact the research staff 
(Appendix J, Appendix P).   
As a third approach, we will use snowball sampling. We will ask community partners and 
previous participants to distribute our study flyer to or refer friends/acquaintances who 
might be interested. 
As a fourth approach, we will post our recruitment flyer in locations frequented by those 
experiencing homelessness (e.g., bus stops, shelter bulletin boards, libraries).  
As a fifth approach, we will include use the electronic health record system at Hennepin 
County Medical Center (HCMC). We will ask staff in the HCMC Analytics Center for 
Excellence to use the existing homeless indicator,49 department, and lab data to generate 
rosters of patients who meet enrollment criteria but who have not opted out of research 
participation. We will contact eligible patients by letter with a follow-up phone call—a 
method we’ve used successfully in the past to recruit unstably housed individuals (Appendix 
K, Appendix L). Care will be taken to ensure letters emphasize the voluntary nature of 
participation and to emphasize that the choice to participate will not impact receipt of health 
care at HCMC or other health systems they may visit. 
If needed, as a sixth approach we will use convenience sampling at healthcare and 
community sites. Study staff will go to sites with informational materials (ADA and CDC 
flyers and pamphlets), study flyers and low-glycemic snacks in order to engage with 
community members about the study face-to-face, and may schedule baseline assessments 
with interested persons (Appendix P). Information sessions will include both one-on-one 
conversations and tabling sessions that take place at a variety of healthcare and community 
settings with permission from each site’s leadership, including Hennepin Healthcare 
facilities, Healthcare for the Homeless clinics, libraries, shelters, and community or social 
service agencies. 
 
9.6  Informed Consent/Assent and HIPAA Authorization 
We will collect signed consent and HIPAA authorization from all participants (Appendix M, 
Appendix N). The consent will also include HIPAA authorization to review their electronic 
health record at Hennepin Healthcare and any other systems where they have gotten care in 
the last year. We will also ask them to sign consent for us to obtain claims data for one year 
before and one year after study participation from their insurance provider. 
Staff will review consent documents with participants and monitor their comprehension 
using teach back methods. 
After presentation of key features of the document, research staff will administer a 4-
question consent quiz to confirm comprehension from all patient participants (Appendix C). 
This will be a written quiz but administered orally to participants who request it. Participants 
must answer all questions on the consent quiz correctly to consent. Research staff may 
administer the quiz up to 2 times, providing feedback for incorrect answers prior to the 
second administration. 
Any and all questions will be answered by study staff and the voluntary nature of 
participation will be emphasized.  

 
  21 
Participants will be given up to thirty minutes to make the decision to participate and more 
time if requested. Those requesting more may be invited to reschedule their baseline 
enrollment visit. 
The consent form is written at the twelve-grade reading level or below. We will be getting 
feedback on the consent form and plan to submit a modification at a reduced reading level at 
a later date. 
If any participant appears to be under the influence of drugs or alcohol or unstable from a 
mental health perspective, or otherwise unable to consent, or if they fail the consent quiz, we 
will politely exclude them from participating.  
If COVID-19 or other logistics necessitate, baseline visits 1 and 2 and treatment visit 1 will 
be conducted by phone or secure video platform (HHRI Zoom and/or HHRI/HCMC or 
Hennepin County Teams). See Appendix O for our e-consent protocol. 
9.7  Payment to Subjects/Families 
Participants will be paid for their participation in three ways: 
(1) Reimbursement for travel, parking, and cell phone minutes/text messages for all 
assessment and treatment visits 
(2) Payment for time, effort, and inconvenience of assessment visits 
(3) Gifts in the form of tools and incentives to enhance behavior change goals 
9.7.1  Reimbursement for travel, parking, and cell phone minutes/text messages 
Reimbursement for travel/parking for in-person visits and phone minutes/text messages for 
virtual or phone visits be reimbursed at $10 cash per visit. This will be given to participants 
who decline a cab ride to any in-person visits. We will provide a $20 bonus payment for 
participants who complete all 10 scheduled treatment sessions. Maximum travel and 
data/minutes reimbursement is summarized below:  
 
 
 
Baseline 
visit 1 
Baseline 
visit 2  
Tx 
visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Final 
visit 
Total 
$10 
$10 
$10 
$10 $10 $10 $10 $10 $10 $10 $10 $10 $20 
$140 
Note: If Baseline 2 + Treatment visit 1 happen concurrently, total will be $130. 
Payment for treatment sessions will occur at each in-person visit. Phone visits will be 
reimbursed at the next in-person treatment or assessment visit or mailed or picked up at a 
homeless drop-in center per participant preference. 
Further, participants who receive a study phone to facilitate their participation will receive 
$20 for return of the study phone and charging equipment at the end of the study. 
 
9.7.2  Payments to subject for time, effort, and inconvenience (i.e. compensation) 
Participants will be additionally reimbursed for study assessment visits at baseline and 12-
weeks for their effort and inconvenience. This includes a finger-stick blood draw at each 
visit. We will compensate participants $30 for the baseline visits ($10 at visit 1 and $20 at 
visit 2) and $45 for the final assessment visit. Compensation will be in the form of cash. 
Maximum total compensation will be $75. 
The amount and form of these payments were set with input and approval by our multi-
stakeholder research team of people with lived experience and multi-disciplinary providers. 

 
  22 
 
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11 APPENDIX (ATTACHED SEPARATELY) 
Appendix A—Patient Screening Survey 
Appendix B—Health Care for the Homeless letter of support 
Appendix C—Consent quiz 
Appendix D—Home visit safety protocol 
Appendix E—Phone/Tablet Agreement 
Appendix F—Tools and Educational materials 
Appendix G—Biometric data 
Appendix H—A1c results sheet 
Appendix I—Final Assessment Interview 
Appendix J—Recruitment flyer 
Appendix K—Recruitment letter 
Appendix L—Recruitment phone script 
Appendix M—HIPAA authorization 
Appendix N—Informed consent 
Appendix O—eConsent protocol 
Appendix P—Recruitment Postcard Flyer