Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2, Housing Problems, Psychological Distress
Sponsor: Hennepin Healthcare Research Institute

Attachment UUU 
Template version: March 27, 2019 
Template adapted from: Children’s Hospital of Philadelphia Research Institute 
Title: 
Development of the Diabetes Homeless Support (D-Homes) Program 
– Part Three 
Drug or Device 
Name(s): 
Not applicable (N/A) 
FDA IND/IDE  
N/A 
NCT Number 
Sponsor: 
NCT05258630 
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): 
05/19/23 
 
 
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 
 

 
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TABLE OF CONTENTS 
PROTOCOL SYNOPSIS .................................................................................................... III 
TABLE 1: SCHEDULE OF STUDY ASSESSMENT PROCEDURES ....................... VII 
TABLE 2: SCHEDULE OF STUDY TREATMENT PROCEDURES ....................... VIII 
2 
BACKGROUND INFORMATION AND RATIONALE .......................................... 1 
3 
STUDY OBJECTIVES ................................................................................................. 5 
4 
INVESTIGATIONAL PLAN ....................................................................................... 6 
5 
STUDY PROCEDURES ............................................................................................... 9 
6 
STUDY EVALUATIONS AND MEASUREMENTS ............................................... 13 
7 
STATISTICAL CONSIDERATIONS ....................................................................... 15 
8      SAFETY MANAGEMENT ........................................................................................ 17 
9 
STUDY ADMINISTRATION .................................................................................... 18 
10 REFERENCES ............................................................................................................ 24 
11 APPENDICES (ATTACHED SEPARATELY) ........................................................... 31 
 
 
 

 
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PROTOCOL SYNOPSIS 
Study Title 
The Diabetes Homeless Medication Support (D-Homes) 
Program – Part Three 
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. 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.  
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.  
We will consider the study feasible if we enroll 75% of those 
screened who meet inclusion criteria, and 75% of enrolled 
participants complete at least one follow-up. We will consider 50% 
session attendance as indicative of feasibility. We will consider the 
intervention acceptable if 70% of participants are satisfied and 
would recommend it to others.  
The goal of the current study is to conduct a randomized pilot trial 
of the D-HOMES program. D-HOMES is a coaching-based 
collaborative care intervention tailored to DH using behavioral 
activation, motivational interviewing and psychosocial support to 
improve medication adherence. We will compare this to brief 
diabetes education and referral to meet medical and psychosocial 
needs. Our team’s central hypothesis is that medication adherence, 
glycemic control, health care use/cost will improve with D-HOMES 
more than in our comparison. This pilot trial is under-powered to 
assess efficacy and focuses on recruitment, retention, blinding, and 
randomization procedures. 
Study Objective(s) 
Primary  

 
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To conduct a randomized pilot trial of the D-Homes  
intervention  
Secondary 
• 
To refine efficacy measures for future D-Homes evaluation  
Test Article(s) 
D-HOMES behavioral intervention to support medication adherence 
Study Design 
Randomized pilot trial 
Subject Population 
Key Criteria for 
Inclusion and Exclusion: 
We will enroll adults (age > 18 yrs.) with type 2 diabetes who have 
experienced homelessness. 
Inclusion criteria: 
1. Age 18 yrs. or older 
2. English-speaking 
3. Recent homelessness by federal definition (HEARTH ACT) 
a. Any housing instability in the last 12 mo. (includes 
supported housing or worry about paying rent) 
b. Significant housing instability in the last 24 mos. 
(includes any stay in shelter, outside, or places not 
meant for human habitation) 
4. Self-reported diagnosis of type 2 diabetes with A1c >7.5%, 
later verified in medical record and study point-of-care lab. 
test 
5. Plan to stay in local area or be reachable by phone for the 
next 24 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 people.  
Number Of Subjects  
 
Total Number of Subjects: 54 
Total Number at Hennepin Healthcare: Unknown  
Total Number of Sites: 1 (Hennepin Healthcare) 
Study Duration 
Each subject’s participation will last 24-30 weeks. 
The entire study is expected to last up to 24 months. 
Study Phases 
Screening 
Intervention 
 
1. Screening: screening for eligibility and consent, baseline 
assessment 
2. Randomization to: 
        a. Intervention: study intervention with weekly coaching 
support in person and/or by phone x 12 week 

 
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Follow-Up   
          b. Comparison: one-time diabetes education session 
3. Follow-up 1: 12-16-week follow-up assessments and A1c 
      Follow-up 2: 24-30-week follow-up assessments and A1c 
Efficacy Evaluations 
• Satisfaction with trial, recruitment, retention rates 
• Hemoglobin A1c measured by point-of-care fingerstick or 
venipuncture  
• Self-reported medication adherence 
• Self-reported psychological wellness 
• Self-reported diabetes self-management, distress  
• Height, weight, blood pressure 
Safety Evaluations 
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 values during 
assessment visits 
Statistical And Analytic 
Plan 
We hypothesize a satisfactory, feasible, acceptable intervention with 
adequate recruitment and retention rates. We may see early 
indicators of improvement in efficacy measures of adherence, 
glycemic control, and wellness among intervention participants 
compared to comparison.  
We will consider the study feasible if we screen 50% of those 
referred, enroll 75% of those screened who meet inclusion criteria, 
and 75% of participants complete follow-up. We will consider 70% 
session attendance as indicative of feasibility. We will consider the 
intervention 
acceptable if 70% of participants are satisfied and would 
recommend it to others.  
We will use generalized linear models to compare changes in A1c 
and medication adherence over time in intervention vs. comparison 
groups according to the ARMS-D measure of diabetes medication 
adherence while controlling for baseline differences and changes in 
housing status over time. Adherence will also be examined with 
pharmacy refill data (continuous medication gap for non-insulin 
diabetes medications 0-1.0).92 We will use an intention-to-treat 
approach including all randomized participants; multiple 
imputation93 will generate data for those lost to follow-up. Similar 
modeling approaches will compare psychological wellness, and 
other biometric and patient-reported outcomes. 
Data And Safety 
Monitoring Plan 
Dr. Vickery (PI) will work closely with study staff to monitor the 
quality of data collected at assessment. This pilot trial (N=54), does 
not meet NIH criteria requiring a Data Safety Monitoring Board 

 
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(DSMB), however Drs. Vickery, Busch, and Connett will oversee a 
detailed safety monitoring plan. 

 
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TABLE 1: SCHEDULE OF STUDY ASSESSMENT PROCEDURES  
Study Phase 
Eligibility 
screening 
Consent, 
Baseline 
visit #1 
Run-in, 
Baseline 
visit #2 
Follow-up 
visit #1 
 
Follow-up 
visit #2 
Visit Number 
 
1 
2 
3 
4 
Study Weeks, approximate 
0 
1 
2-3 
12-16 
24-30 
Confirm communication preferences 
X 
X 
 
X 
X 
Review Inclusion/Exclusion Criteria 
X 
X 
X 
 
 
Informed Consent 
 
X 
 
 
 
Demographics/Medical History/Medication List 
 
X 
X 
 
 
Medical records and insurance access permissions 
 
X 
  
  
X 
Biometrics: BP, Height, Weight, Hemoglobin A1c (fingerstick/venipuncture) 
 
X 
X 
X 
X 
Medication review 
 
X 
X 
X 
X 
Self-report survey measures: 
 
 
 
 
 
Mental Health Inventory (MHI-5)115 
 
 
X 
X 
X 
Health-related Quality of Life Short Form (SF-12)116 
 
 
X 
X 
X 
Problem Areas in Diabetes (5-item PAID)113 
 
 
X 
X 
X 
Diabetes self-management questionnaire (DSMQ)105 
 
 
X 
X 
X 
Adherence to Refills and Medications Scales-Diabetes (ARMS-D)111 
 
 
X 
X 
X 
Self-reported medication adherence (Adherence Starts with Knowledge, ASK-12)106 
 
 
X 
X 
X 
Basic needs survey107 
 
X 
 
X 
X 
Lifetime housing status 
 
X 
 
 
 
Current housing status, 30 day recall 
 
X 
 
X 
X 
Use of substances (ASSIST) 
 
X 
 
X 
 
Self-reported health care use (NHANES) 
 
X 
 
X 
X 
Discrimination in Medical Settings Scale 117 
 
X 
 
 
 
Client Satisfaction Questionnaire (CSQ-8) 95 
 
 
 
X 
 

 
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TABLE 2: SCHEDULE OF STUDY TREATMENT PROCEDURES  
Intervention group,  
10 weekly coaching offered over 12 weeks 
Session #1 in-person on day of baseline assessment visit 2 
Sessions #2-10 offered in-person or via phone/video 
Monthly booster calls from 12-24 weeks 
Comparison group, 
 
1 educational session (15-30 min.) offered in-person on 
day of baseline assessment visit 2 
Monthly calls to retain contact from weeks 3-30 

 
  
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2 
BACKGROUND INFORMATION AND RATIONALE 
OVERVIEW 
This protocol is for the third and final part of a set of studies with an overall goal to develop 
and pilot test the Diabetes Homeless Medication Support (D-Homes) program. D-Homes is 
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 part 2 (HSR #20-4863). Part 2 was a single arm treatment 
development trial that tested the feasibility and acceptability of study procedures and refined 
the D-Homes treatment manual through test cases (n=10-15). We found the D-Homes 
manual and study procedures are feasible and acceptable to DH as measured by self-report 
and post-treatment interview but that treatment engagement lessened for participants with 
the highest degrees of housing instability. 
This protocol describes part 3, a fully randomized pilot study in concordance with study 
Aim 3. 
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 
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)

 
  
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significant early hyperglycemia despite later glucose normalization.25 While 
homelessness and unstable housing are increasingly recognized for 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 

 
  
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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 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. 
 
Figure 2. D-HOMES Treatment model 

 
  
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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. 
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.  
 
 

 
  
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3 
STUDY OBJECTIVES 
The purpose of the study is to 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 conduct a randomized pilot trial of the D-Homes 
intervention. This will support our ultimate goal to determine the efficacy of this 10-session 
behavioral activation and motivational interviewing support program for DH in a future, 
fully-powered study. The outcomes we will use to assess this pilot phase of our work will be 
participant satisfaction, our ability to recruit and retain participants, the acceptability and 
process of the comparison group, and follow-up until a 24-week final assessment visit. 
3.2 
Secondary Objectives (or Aim) 
The secondary objectives will be to refine efficacy measures for future D-Homes evaluation 
We will: 
• Assess the acceptability of patient-reported outcome measures to detect changes at 
follow-up visits #1 and #2 (24-30 weeks). 
• We will establish and refine laboratory testing protocols for use of a consistent point-
of-care A1c machine which our team will control 
 
 
 

 
  
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4 
INVESTIGATIONAL PLAN 
4.1 
General Schema of Study Design 
This is a randomized pilot trial to inform development of the D-HOMES behavioral 
treatment, see Tables 1 and 2 above. The intervention, see Figure 2 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. 
4.1.1 Screening Phase and Baseline Assessment 
Recruitment protocols are summarized in section 9.5 below but will involve (1) referral 
from Health Care for the Homeless, Hennepin Healthcare, supportive housing providers, or 
other community organizations, (2) snowball sampling using advertisements (flyers, video), 
word of mouth, and referrals via community partners and previous participants, (3) 
community advertisement using flyers in places such as bus stops, libraries, and shelters, 
and (4) invitation letters and follow-up calls to eligible patients at Hennepin Healthcare, (5) 
invitation letters and follow-up phone calls to eligible Hennepin County clinic patients at 
Health Care for the Homeless and other willing sites. Per review by the County’s internal 
research review committee (IRRC), these letters and calls will be generated by county 
employees and handed over to research staff once interested participants are identified, (6) 
tabling events with study flyers and snacks at Hennepin Healthcare, Health Care for the 
Homeless facilities, supportive housing or community partners such as libraries, shelters, 
and drop-in homeless service centers. Potential subjects will be screened in-person or by 
phone using the protocol inclusion and exclusion criteria. 
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 in both the intervention and comparison groups.  
4.1.2 Study Intervention 
This study will be offered to willing participants as an adjunctive to usual diabetes care. No 
prescriptions will be changed by study staff. Throughout the study, 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 treatment 
sessions or requested to end their sessions early. Since the emphasis of this pilot trial 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 
Participants will be randomized to either the intervention or a control group (1:1). 
Randomization will be stratified by housing type (unstable (e.g., shelter, staying outside) vs. 

 
  
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more stable (e.g., worry about rent payment, supportive or transitional housing)). 
Randomization will occur after baseline assessment visit #2 via REDCap. Staff who conduct 
who conduct the follow-up assessment visits will be blind to condition. 
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. Intervention 
participants 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. Intervention participants will receive monthly booster calls from coaches 
after weekly coaching ends through week 24 post enrollment. Comparison participants will 
engage in a one-time diabetes education session. Comparison participants will receive 
monthly check-in calls by study staff to update contact information beginning at 6 weeks 
through week 24. All participants will also complete a two follow-up assessment visits. To 
maximize participation, these follow-up visits can occur 1 week after intervention and up to 
30 weeks after enrollment.  
4.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
Enrollment for the study will continue until 54 participants have been enrolled. 
HHRI will serve as the only site for this study.  
4.3.3 Use of Vulnerable Populations and Patients Who Opt Out of Research 
This study focuses on adults experiencing type 2 diabetes who have experienced recent 
homelessness per the HEARTH Act definition (Box). 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 2 of this study (HSR#20-4863). See Consent Quiz. 
Furthermore, we will continue working closely with community providers in this area and 
our 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 in their annual consent process through 
the health system will contacted about the study although they will be allowed to participate 
if they reach out to study staff in response to flyers or other community invitations.  
4.5 
Inclusion and Exclusion Criteria 
4.5.1   Inclusion Criteria 
Inclusion criteria: 
1. Age 18 yrs. or older 
2. English-speaking 
3. Recent homelessness by federal definition (HEARTH ACT) 
a. Any housing instability in the last 12 mo. (includes supported housing or 
worry about paying rent) 

 
  
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b. Significant housing instability in the last 24 mos. (includes any stay in 
shelter, outside, or places not meant for human habitation) 
4. Self-reported diagnosis of type 2 diabetes, later verified in medical record 
5. Verification of hemoglobin A1c value at or above 7.5% by study-administered test at 
baseline 1 visit 
6. Plan to stay in local area or be reachable by phone for the next 24 weeks 
7. 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 people.  
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.  
 
 

 
  
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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 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, A1c results, 
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 months. If 
patients are found not to have diabetes at this point, they will be excluded from the study. 
We will also process their point-of-care A1c after visit #1 to ensure eligibility. 
If patients are confirmed to be eligible based on medical record review, we will proceed 
with baseline visit 2 which can be done remotely or in-person.  
As outlined in Table 1 above, the screening visit and baseline assessment visits will collect: 
• Review Inclusion/Exclusion Criteria 
• Informed Consent, HIPPA authorization 
• Demographics/Medical History/Medication list 
• Release of information for health systems used in last 12 mo.  
• Release of information for insurance claims data in the last 12 mo.  
• Biometrics: BP, height and weight, hemoglobin A1c (A1c) 
o Alc testing involves the collection of a 1.5 µL blood sample via 
fingerstick or venipuncture 
• Patient-reported outcome survey items (See Table 1) 
5.2 
 Study Intervention  
For participants randomized to the intervention group, they will be offered 10 coaching 
sessions over 12 weeks. These will be conducted in-person, via secure video, and/or by 
phone-based per participant preference and COVID-19 safety protocols. The treatment will 
center on providing diabetes education, motivational and goal-setting support, and resource 
and care coordination (Figure 2).  
In-person assessment visits will be conducted at private spaces convenient to the participant 
including Hennepin Healthcare, Health Care for the Homeless sites, or at participant homes 
(see Home Visit Protocol). 
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 that may include the participants home  
Video visits will be conducted via a secure Zoom or Teams link (using HHRI, Hennepin 
Healthcare, and/or Hennepin County HIPAA secure technology) or Facetime if the 
participant is using an Apple device.  

 
  
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Phone visits will be conducted via a study or office phone or the PI’s work phone. If 
participants have no working phone, a study phone will be issued to participants and will 
sign a Study Issued Cell Phone/Tablet Agreement (See Phone/Tablet Agreement). 
Psychological approaches of behavioral activation and motivational interviewing will be 
used along with provision of educational materials and tools to support behavior change 
(See Tools and Education Materials). Coaches will tailor which tools and educational 
materials are given to which participants 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 tools ranges from $4.99 (glucose log book) to $17.91 (Adhesives for Continuous Glucose 
Monitor).  
Approved communication channels will be used to support participant’s goal setting (e.g. 
reminders) and arrange study related visits. 
Participants will be offered up to 10 treatment visits over 12 weeks and monthly booster 
calls from weeks 12-24. 
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 medication adherence and 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)  
• Assess existing diabetes care team; refer 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, calendar; see 
Tools and Education Materials 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 

 
  
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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 to maintain long-term diabetes adherence goals 
5.2.6 Intervention group booster calls 
Interventionists will offer monthly booster calls after the end of the intervention period 
(approx. 12-14 weeks post-enrollment), and prior to the follow-up assessment visit #2. 
Contact will be limited to a once-monthly to reinforce planned behavioral activation goals, 
update participant contact information, and arrange final follow up visit. 
5.2.7 Comparison Group 
Participants randomized into the comparison group will receive one 15 to 30-minute 
diabetes education session. Interventionists (coaches) will read the content of 3 diabetes 
educational handouts about (1) general descriptions of type 2 diabetes, (2) healthy eating, 
and (3) physical activity. Handouts are produced in alignment with American Diabetes 
Association guidelines by a community group (https://learningaboutdiabetes.org/) and have 
been used in previous diabetes behavioral trials118 with participants in low-income 
situations. Participants will receive a standard pillbox at this visit. Participants will receive a 
resource sheet with referral information to establish health care, mental health support, or to 
access local resources for housing, food, and other basic needs. 
Comparison group participants will be contacted by the study staff (non-interventionists) 
once-monthly starting 4 weeks after their education session through the final assessment 
visit. Booster calls will update participant contact information and remind them of the 
timeline for follow-up assessments.  

 
  
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5.2.8 Follow-up Assessments 
The follow-up assessments will be completed by a blinded research staff member. The staff 
person will assess: 
• Vital Signs: BP 
• Height and Weight 
• Hemoglobin A1c 
• Medication review 
• Patient-reported measures, see Table 1 for timeline and specific measures 
5.3 
Unscheduled Visits 
Contact between the study team and participant during the 24-week study period will be 
encouraged. This will include reminders of study-related assessments and coaching visits.  
The interventionist will work with intervention participants to set treatment goals related to 
improved diabetes care. These may include between-visit text messages, calls, e-mails, or 
private messages on 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.  
Study staff will respond to participant-initiated communications from comparison group 
participants. They will refer participants to locally available resources on the handout for 
any expressed needs. 
Should communications become too frequent or surpass agreed upon boundaries with any 
participants, staff will be guided to set boundaries and limit contact by Drs. Vickery and/or 
Busch.  
5.4 
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 via self-report.  
5.5 
Rescue Medication Administration  Not applicable in this behavioral trial. 
5.6 
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 adverse events (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. 
5.6.1 Early Termination Study Visit  
Any participant who withdraws will be contacted by the PI to be offered the opportunity to 
complete any outstanding assessment visits with compensation. 
 
 

 
  
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6 
STUDY EVALUATIONS AND MEASUREMENTS 
6.1 
Screening and Monitoring Evaluations and Measurements 
Our pre-consent phone screening will closely parallel the phone screenings used in previous 
parts of this study. This has been 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 24-
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 DH Aim 3 Screener Script for question structure. 
During the baseline and follow-up assessment visits data will be collected using the 
following procedures: 
Demographics/ 
Medical History 
Participants will be given a verbal survey at either the Baseline 1 or Baseline 2 
visit to add to data collected in pre-consent screening.  
Topics will include: health insurance, education, medical history, and current 
living situation.  
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 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 
• 
History of hemoglobin A1c: Mo./year, results of tests 
After the follow-up assessment visits, we will review and abstract any changes 
in:  
• 
Medication list, dose, frequency, and prescriber 
• 
History of medication refill frequency 
• 
History of hemoglobin A1c: Data and results of tests 
Insurance 
company claims 
data 
We will collect data from health insurers including Minnesota Medical 
Assistance. We will work directly with Hennepin County per instructions of the 
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. 

 
  
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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 explore the feasibility of using pre-established protocols 
to examine hospitalizations for hyper and hypoglycemia.109  
Biometric data 
The following biometric data will be collected from participants at baseline and 
both follow-up assessment visits. See Biometric Data for detailed information on 
how these will be measured: 
• 
Blood pressure 
• 
Height 
• 
Weight 
• 
Hemoglobin A1c--Participants will receive a copy of their results. See 
HgA1c Result for A1c results sheet. 
Medication review Patients will be asked to bring a list of 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. 
Patient-reported 
survey measures 
Formal assessment surveys will be collected at Baseline and follow-up 
assessment visits as described in Table 1. 
Satisfaction with 
intervention 
At the 16-week 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 
 
6.2 
Efficacy Evaluations 
Although our study is not fully powered to detect efficacy, we will collect the following 
eventual efficacy measures to prepare for later, fully-powered testing at baseline and both 
follow-up assessment visits (Table 1): 
• Hemoglobin A1c (primary) 
• Adherence to diabetes medications (ARMS-D) (secondary) 
• Adherence to all medications (ASK-12) (secondary) 
• Diabetes self-care (DSMQ) (secondary) 
• Difficulties with diabetes management (PAID) (secondary) 
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 follow-up assessment visits. See Section 8 for details. 
 
 
 

 
  
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7 
STATISTICAL CONSIDERATIONS 
7.1 Primary Endpoint 
The primary endpoint of this study is the satisfaction of participants in this pilot randomized 
trial (via CSQ-8). 
The feasibility and acceptability of study protocols for recruitment, retention, and 
randomization are also important. We will assess this by measuring our ability to recruit and 
retain participants, and the assessment and treatment visits we can deliver (i.e., participant’s 
attendance and follow-up with scheduled sessions and treatment activities). In addition to 
above outcomes, we will 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 consider the study feasible if we enroll 75% of those screened who meet inclusion 
criteria, and 75% of enrolled participants complete at least one follow-up. We will consider 
50% session attendance as indicative of feasibility. We will consider the intervention 
acceptable if 70% of participants are satisfied and would recommend it to others.  
We will also analyze our primary clinical endpoint of change in A1c between intervention 
and comparison groups between baseline follow-up visit #1 (approx. 12-16 weeks)  
if it changes from baseline to between intervention.  
7.2 Secondary Endpoints 
Secondary endpoints will include the following changes from baseline to follow-up visit #1 
(approx. 12-16 weeks) between intervention and comparison groups. 
• Psychological wellness (SF-12, MHI-5) 
• Adherence to diabetes medications (ARMS-D) (secondary) 
• Adherence to all medications (ASK-12) (secondary) 
• Diabetes self-care (DSMQ) (secondary) 
• Difficulties with diabetes management (PAID) (secondary) 
Secondary endpoints will also include change from baseline to follow-up visit #2 (approx. 
24-30 weeks) of A1c to assess sustained change of our primary endpoint. 
We will also complete exploratory analyses on the change from baseline to follow-up visit 
#2 of: 
• Adherence to diabetes medications (ARMS-D)  
• Adherence to all medications (ASK-12)  
• Diabetes self-care (DSMQ)  
• Difficulties with diabetes management (PAID)  
Exploratory analyses will further measure changes from baseline to follow-up visits #1 and 
#2 of other self-reported and claims-measures will be assessed including housing status, 
substance use, and other biometric measures (BP, BMI). Exploratory analyses will also 
compare self-reported adherence measures (ARMS-D and ASK-12) to measures built from 
medication refill patterns in insurance claims. 

 
  
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7.3 Statistical Methods 
Statistical support for this trial will be provided by Dr. Connett and Mr. Evans via the 
Biostatistical Design and Analytics Center (BDAC) at UMN. 
7.4 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). 
7.4.1 Efficacy Analysis  
We will use summary statistics (mean, standard deviation) to examine CSQ-8 scores for all 
participants. We will use t-tests to examine the differences in CSQ-8 scores between the 
intervention and comparison groups; we hypothesize no difference. We will also examine 
the experiences of White vs. Black, Native American, and Hispanic participants. We will 
also generate summaries of the age, gender, and race/ethnicity of people at the highest and 
lowest quintiles of CSQ-8 scores. 
We will use generalized linear models to compare changes in A1c and medication adherence 
(ARMS-D and ASK-12) over time in intervention vs. comparison groups. We will control 
for baseline differences and changes in housing status over time. Adherence will also be 
examined with pharmacy refill data which we will compare to self-report (ARMS-D and 
ASK-12).92 We will use an intention-to-treat approach including all randomized participants; 
multiple imputation93 will generate data for those lost to follow-up. Similar modeling 
approaches will compare psychological wellness, blood pressure, and health care use 
outcomes. 
7.4.2 Pharmacokinetic Analysis Not applicable. 
7.4.3 Safety Analysis 
We will complete quarterly data reviews to examine safety events in the intervention and 
comparison groups. Dr. Connett will advise us if any changes to the existing study protocol 
are needed to ensure patient safety.   
7.5 
Sample Size and Power 
This sample size is appropriate for the goal of feasibility and acceptability of the 
intervention. This is in line with ongoing studies by Dr. Busch (HSR#17-4351) as well as 
the current literature.110 
 
 

 
  
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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. Adverse event reports will be reviewed annually with the 
HHRI IRB to ensure participant safety. 
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 any reported safety events and determine subsequent action. Any subsequent 
action will be documented and reported to the HHRI IRB and the Program Officer at NIH.  
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 
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 (See Resource List). 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 (See Resource 
List). 
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 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 

 
  
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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 Randomization will occur at the 2nd baseline 
visit, and will be done using a pre-generated randomization schedule in REDCap. 
Randomization will be stratified into 2 strata based on severity of housing instability: 
“unstable” (e.g., living in shelter, staying outside) and “more stable” (e.g., history of 
homelessness that’s now resolved, worry about rent payment, subsidized housing). 
9.1.2  Blinding Staff who conduct the follow-up assessment visits will be blind to condition.  
9.1.3  Unblinding Multiple staff members will be trained in how to complete the outcome 
assessments. In the event that a staff member is unblinded during the first follow-up 
assessment visit, a different blinded assessor will complete the 24-week visit. 
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. If needed due to Covid-19, we will follow our HHRI-approved e-consent 
procedures (see Consent/Assent Documents). 
Data from self-reported survey items administered during screening interviews and 
assessment visits will be entered and stored in REDCap. If needed (e.g. no available wifi at 
community screening event), paper copies will be used. Physical copies such paper 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 will be audio recorded and reviewed during coach supervision 
meetings with Drs. Vickery and Busch. Once audio recordings are uploaded to the HHRI-
maintained 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, 12/31/2024.  
Since assessment visits may 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 

 
  
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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, 12/31/2024.  
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. If request for data is received, we 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 which 
will not include PHI.  
9.4  Regulatory and Ethical Considerations 
9.4.1  Data and Safety Monitoring Plan 
This treatment development study (N=54), does not meet NIH criteria requiring a Data 
Safety Monitoring Board (DSMB) due to the small sample size and 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. 
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 

 
  
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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 support with a goal of improved 
diabetes self-management which can reduce their morbidity from this disease. Free 
counseling related to psychological wellness may reduce depression symptoms, stress, and 
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 this 
study. 
9.5 Recruitment Strategy 
We will use a variety of recruitment methods throughout our study to identify participants: 
1. We will include use the electronic health record system at Hennepin Healthcare. We 
will ask staff in the Analytics Center for Excellence to use the existing homeless 
indicator,49 department, upcoming appointment dates, 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 (see Recruitment Materials: Letter) 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. 
2. We will recruit participants via personal invitations staff at local service delivery 
sites for people experiencing homelessness. This includes Health Care for the 
Homeless and other Hennepin County public health clinics and housing workers as 

 
  
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well as community organizations offering rent and housing support in our region. We 
will provide flyers to these staff to distribute to their clients and/or to post in 
appropriate areas of their facilities. The postcard flyer will include an email and 
phone number to invite interested patients to contact the research staff (see 
Recruitment Materials: Flyer).  We will also support these partners to send letters 
(see Recruitment Materials: Letter) to eligible participants and to call them in 
follow-up. We will also support partners to share our recruitment video (see 
uploaded video file) with their patients, clients, and within their own communication 
channels. When interested participants are identified, they will be passed along to 
our study team via email or study phone.  
3. 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. 
4. We will use convenience sampling at health care and community housing sites. 
Study staff will go to sites with informational materials about diabetes, study flyers, 
hygiene kits, study-branded promotional materials (pillboxes, socks, etc.), and low-
glycemic snacks in order to engage with community members about the study face-
to-face. This may include screening on-site with fingerstick A1c testing, which is 
independent of research protocols, and scheduling of baseline assessments with 
interested persons. Our recruitment video may be played at these events. 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, housing facilities, and community or social 
service agencies. 
5. We will post our flyer in locations frequented by those experiencing homelessness 
(e.g., bus stops, drop-in centers, shelter bulletin boards, libraries, etc.). 
9.6  Informed Consent/Assent and HIPAA Authorization 
We will collect signed consent and HIPAA authorization from all participants (see 
Consent/assent documents). 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 insurance 
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 (see Consent 
Quiz). This quiz will be administered orally and 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.  

 
  
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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. 
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 a patient prefers to work remotely or Dr. Vickery deems remote work preferred for public 
health reasons, baseline visits 1 and 2, treatment visits, and outcome visits can be conducted 
by phone or secure video platform (HHRI Zoom and/or HHRI/HCMC or Hennepin County 
Teams). See Consent/assent documents 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 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 will happen at each in-person visit.  
For in-person coaching or assessment visits at Hennepin Healthcare, participants will 
receive 2 bus tokens, $5 for street parking, or a parking voucher for the hospital ramp. In the 
case that a participant who has already screened into the study asks for transportation 
reimbursement prior to their first enrollment visit, we will mail them two bus tokens or 
arrange transportation for the participant.   
We will provide monthly reimbursement for phone minutes/text messages. For participants 
using their own personal phone, they will receive a monthly stipend to support their phone 
bill. They will be paid up to $120 over 6 months either as a cash payment or via ClinCard. 
Participants without a personal phone will be provided with a study phone to use for the 6 
months of the study (no stipend). 
 
 
Study phone provided for your use *OR* 
Use your own phone with 
monthly stipend 
Mo. 1 
Mo. 2 
Mo. 3 
Mo. 4 
Mo. 5 
Mo. 6 
$20 
$20 
$20 
$20 
$20 
$20 
 
9.7.2  Payments to subject for time, effort, and inconvenience (i.e. compensation) 
Participants will be additionally compensated for all four study assessment visits for their 
effort and inconvenience. This includes a fingerstick blood draw with research staff or the 
option of a fingerstick or veinous blood draw at the CSC 2 lab at visits #1, 3, and 4. We will 
compensate participants with either cash or via ClinCard using the following schedule: 
 
Assessment Visits 

 
  
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#1 
#2 
#3  
#4 
Assessment Payment 
$20 
$30 
$40 
$60 
Maximum total compensation will be $150. 
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. 
In the case that the specimen from visit #1,3, or 4 clots, we will offer an extra $10 to repeat 
the fingerstick or veinous blood draw at the lab. We will offer this $10 once for each 
assessment visit that requires a blood draw (three total).  
 
 
 

 
  
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11 APPENDICES (ATTACHED SEPARATELY) 
Study Protocol 
Consent/assent document(s) 
HIPAA authorization for research form 
Data Collection Instruments: DH Aim 3 All Assessment Qs 
Data Collection Instruments: DH Aim 3 Screener Script 
Recruitment Materials: Flyer 
Recruitment Materials: Letter 
ACT checklist 
Other Attachments 
 
Biometric Data 
Consent Quiz 
 
Home Visit Protocol 
 
Phone/Tablet Agreement 
Tools and Education Materials 
 
HbA1c Result 
 
Resource List 
 
Payment Tracker