Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention
Phase: NA
Conditions: Diabetes Mellitus, Type II, Type 2 Diabetes, Diabetes Distress, Self Management, Veteran
Sponsor: VA Office of Research and Development

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 1 of 38 
Tailored Approaches to Reduce Distress and Improve Self-Management for 
Veterans with Diabetes (TARDIS) – Photo Elicitation and Intervention 
 
NCT06972251 
 
Protocol version approved on 10/30/2024 
 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 2 of 38 
PROTOCOL TITLE: Tailored Approaches to Reduce Distress and Improve Self-
Management for Veterans with Diabetes (TARDIS) – Photo Elicitation and Intervention 
 
PRINCIPAL INVESTIGATOR: Allison Lewinski, PhD, MPH (PhD non-clinician) 
 
VERSION NUMBER AND DATE: Version 10 – 08/21/2024 
 
SPONSOR/FUNDING SOURCE: Health Services Research & Development, Nursing 
Research Initiative 
 
Purpose 
Veterans with type 2 diabetes (T2D) may become overwhelmed with the self-
management behaviors needed to maintain optimal health. Veterans may experience 
diabetes distress (DD), a concept distinct from depression, due the amount and 
frequency of these behaviors. Diabetes distress negatively influences the Veteran’s 
engagement in self-management and subsequent glycosylated hemoglobin (HbA1c) 
levels. Previous interventions aimed at improving T2D self-management and reducing 
DD do not tailor T2D self-management information to a Veteran’s DD, which may be 
one reason interventions are ineffective at reducing DD.  
The etiology of DD in Veterans may be different than non-Veterans due to the 
cumulative nature of Veteran-related comorbid psychosocial factors (e.g., post-
traumatic stress disorder (PTSD), depression). Conceptually, DD, depression, and 
PTSD are unique and independent factors; however, in each individual, these factors 
may overlap and negatively impact a Veteran’s engagement in self-management. 
 
The purpose of this research study is to further understand DD by expanding on what 
we have learned thus far in cognitive and semi-structured interviews with Veterans. In 
Aim 3a, the photo elicitation study, the Veteran would be provided with a camera and 
instructed to take approximately 20 photos over two weeks. We would conduct two 
semi-structured interviews with the Veteran to discuss this experience. Visual-based 
qualitative methods will help us identify and more robustly describe DD in Veterans. Aim 
3a will have its own consent documents that are separate from Aim 3b. In Aim 3b, we 
will conduct a feasibility and acceptability trial of a novel telemedicine intervention. Aim 
3b will have its own consent documents that are separate from Aim 3a. 
 
The TARDIS intervention (Aim 3b) will build off data collected in Aim 3a and provide 
tailored coaching to Veterans with type 2 diabetes mellitus. The TARDIS intervention 
includes coaching, self-management information and support, and referrals to VHA 
supportive services delivered via the telephone. TARDIS will augment current VHA care 
for patients with diabetes. All Veterans will continue to receive care from their primary 
clinicians during the study. 
 
Aim 3a and Aim 3b will be performed entirely by our team at the Durham Center of 
Innovation to Accelerate Discovery and Practice Transformation (ADAPT). These data 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 3 of 38 
collected will inform the development of an intervention that will provide tailored 
coaching and self-management information in conjunction with supportive services 
based upon a Veteran’s DD. Aim 3b will be performed by our team, with assistance 
from the diabetes educator for the Durham VAMC catchment area. The purpose of Aim 
3b is to understand the feasibility and acceptability of providing tailored diabetes self-
management and support.  
Background and Significance 
An estimated 20-25% of Veterans are diagnosed with diabetes,1 an incidence three 
times higher than the national rate. Treatment and management of poorly self-managed 
diabetes is costly as medical care costs are 2.3 times higher for individuals with 
diabetes than for those who do not have the disease.2 Regular preventative care is 
essential to prevent comorbidities and maintain optimal health. 
Individuals with T2D provide 99% of their own care; self-management of T2D is person-
specific and ever-present.3 Consistent and sustained self-management decreases 
comorbidity development, and positively influences quality of life and psychosocial 
outcomes.4 Inconsistent self-management increases the risk of poor health outcomes 
including microvascular and/or macrovascular problems and psychosocial 
complications.5 Yet rates of self-management remain sub-optimal.  
T2D self-management is omnipresent, inescapable, and burdensome. A Veteran may 
become overwhelmed and/or frustrated because of the amount and frequency of T2D 
self-management behaviors, and these negative feelings may lead to inattention to 
critical self-management behaviors such as eating healthy or blood glucose checks.6,7 
Veterans often experience challenges to self-management despite knowing the 
importance of these behaviors.3 Self-management challenges include limited access to 
a healthcare provider, unreliable transportation, limited knowledge of healthy food 
options, beliefs about T2D medications, or a lack of support.6-9 Additionally, diabetes 
distress (DD)10 and other psychosocial factors (i.e., depression, post-traumatic stress 
disorder)11,12 negatively influence an individual’s engagement in self-management and 
health outcomes. Due to the inherent complexity of T2D self-management, we propose 
that tailoring on DD is one way to focus the provision of tailored self-management 
information and connections to supportive services. 
Diabetes distress encompasses the cognitive, physical, and affective experience of 
living with T2D. Diabetes distress occurs when an individual is overwhelmed with T2D, 
related self-management behaviors, and knowledge that T2D is progressive and 
uncurable.10 Diabetes distress is subjective and person-specific; and while DD may 
fluctuate over time, DD may be continually present.10,13-15 Undiagnosed and untreated 
DD, may be one cause of a Veteran’s poor self-management, thus resulting in poor 
health outcomes.  
Diabetes distress is commonly assessed via the Diabetes Distress Scale14 or the 
Problem Areas in Diabetes Scale.16 Research indicates both measures demonstrate the 
construct of DD is distinct from general anxiety, stress, and depression.13,17-19 Both the 
Diabetes Distress Scale and Problem Areas in Diabetes scales assess DD in several 
domains, and each DD domain addresses a separate aspect of the burden of 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 4 of 38 
T2D.14,20,21 The Diabetes Distress Scale measures DD in four domains (i.e., regimen, 
emotional, interpersonal, healthcare provider),14 and the Problem Areas in Diabetes 
Scale assesses DD using similar domains (i.e., emotional, diabetes management, 
treatment, and social support burden).10,22 The Diabetes Distress Scale and Problem 
Areas in Diabetes Scale have demonstrated content validity in measuring an individual’s 
perception of the resources available, or not available, for self-management.13,19 
Diabetes distress is associated with more T2D complications, increased stress, being 
prescribed insulin by a healthcare provider, poor diet and exercise, inadequate support 
environments, and is more prevalent among women.10,19,23-26 Diabetes distress levels 
correlate with self-management behaviors such as monitoring one’s diet, engaging with 
providers, and monitoring one’s blood glucose.9,15,27-29 High to moderate levels of DD 
are related to poorer glucose regulation15, higher HbA1c20, lower medication 
adherence30, and poorer quality of life.31 Individuals with DD report diabetes-related 
physical burden, health care system distress, and distress with comorbid conditions.9 In 
this proposal, we will further examine the Veteran’s experience of DD.  
 
The TARDIS grant and the prior work done for TARDIS was based upon the original 
Diabetes Distress Scale (DDS) and the four domains within that scale. Those domains 
include: regimen, provider, interpersonal, and emotional. In 2022, the authors of the 
Diabetes Distress Scale published an updated version of the DDS called the Type 2 
Diabetes Distress Assessment System (T2D-DDAS). The T2D-DDAS contains core and 
source items that contribute to DD. The T2D-DDAS sources include: hypoglycemia, 
long-term health, health care provider, interpersonal issues, shame/stigma, healthcare 
access, and management demands. The sources or facets of DD we identified in the 
TARDIS foundational work are reflected in the T2D-DDAS. Of note, we identified 
several additional facets of DD in our work such as pain, military experience, living with 
comorbidities, and being a caregiver. The scoring for low, moderate, and high DD in the 
DDS and the T2D-DDAS is the same. For the TARDIS intervention, we will be focusing 
on the domains of DD as measured by the DDS and not the sources of DD as 
measured by the T2D-DDAS. The DDS is in the Cerner EHR and is being used in the 
VA and the foundational TARDIS work uses the DDS. 
 
Aim 3a: Visual Based Qualitative Methods 
Visual-based qualitative methods will help us identify and more robustly describe DD in 
Veterans and will expand on what we have learned thus far in cognitive and semi-
structured interviews. Veterans will have the autonomy to select photos that impact, 
either positively or negatively, their DD and diabetes self-management behaviors. 
Veterans who participate in the project may want to share their experiences because 
this is their personal story which they want to share to help other people. The Veteran 
has the autonomy to decide what, and how much, information to share.  
Aim 3b: TARDIS Intervention  
The TARDIS intervention builds upon data collected in Aim 3a. Health coaching is a 
person-centered approach to identifying health goals, challenges to these goals, and 
then developing strategies to address these challenges. For the purposes of TARDIS, 
interactions are 1:1 between a ‘coach’, or someone who has received training in 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 5 of 38 
motivational interviewing, and a Veteran with T2DM. This personalized approach can 
help elicit, understand, and address the experience of DD, and its impact on T2DM self-
management, in Veterans with T2DM. With personalized, Veteran-centric information 
and support, a Veteran may be more equipped to implement self-management to 
overcome his/her personal modifiable challenges to engaging in T2DM self-
management.  
 
Design 
For Aims 3a and 3b, only individuals officially assigned to the study team will have 
access to individually identifiable information about human subjects. This will include the 
principal investigator, mentors and consultants, statistician, computer programmer, 
research assistant, project coordinator, qualitative analyst, and interventionists. All of 
these individuals will have completed VA required human subjects training and will be 
included on a staff listing with the DVAHCS IRB. Some data described above (e.g., 
HbA1c, health conditions noted in medical records) will be accessed from information 
already collected as part of usual care. All additional data collected from subjects will be 
specifically for the proposed research project and not a part of clinical care. Specifically, 
for Aim 3b, we will use a single-arm feasibility and acceptability design. In order to 
evaluate the feasibility and acceptability of delivering TARDIS within a single VHA site, 
we will enroll from Veterans Affairs Medical Centers (VAMCs) in Durham, NC. We will 
consent up to ~40 Veterans in order to enroll ~30 Veterans with HbA1c ≥8.5% (type 2 
diabetes only) to receive TARDIS in addition to standard VHA care (HT care 
coordination and telemonitoring; or standard VA diabetes care). All participants will 
receive TARDIS for 3 months, during which time they will also continue to receive usual 
VHA care. We will quantitatively and qualitatively examine DD and feasibility and 
acceptability of TARDIS. Study flow is described in the Figure below. Additionally, for 
Aim 3b we will conduct qualitative interviews to further understand the process of 
implementing TARDIS within the context of the Durham VAMC. In conducting this 
evaluation, study team members at ADAPT will speak with Veterans who participated in 
TARDIS, TARDIS study staff (HSR&D interventionist), and VA Durham staff at the 
participating VAMC. The data we are generating will inform future VA implementation of 
TARDIS, ultimately assuring that rural Veterans have access to effective, context-
appropriate diabetes management options. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 6 of 38 
 
 
Risk/Benefit Assessment 
 
Selection of Subjects 
For Aims 3a and 3b, potentially eligible patients will initially be identified via VA 
CDW/electronic health records data extract. (ICD-10 codes: E11.9, E11.8, and other 
inclusionary criteria detailed below, as well as the absence of any exclusionary 
diagnoses).  
We plan to conduct qualitative interviews with VAMC staff members at participating 
sites, to gather feedback on the process of implementing TARDIS. Staff members that 
we will approach will include the diabetes educator, HSR&D interventionists delivering 
the program, and other stakeholders (clinicians, clinical and administrative leadership). 
We anticipate contacting a maximum of 6 staff members in order to evaluate TARDIS.  
Inclusion and Exclusion Criteria (for Aims 3a and 3b unless otherwise 
indicated) 
Veterans must meet all inclusion 
criteria 
Veterans who meet any one of the exclusion 
criteria will be excluded.  
• Diagnosis of type 2 diabetes 
(ICD-10 codes: E11.9, E11.8) 
• Documentation of HbA1c drawn 
within the past 180 days 
• Able to speak and read English 
• Be able to provide informed 
consent to participate in the 
study.  
• Own a smartphone or mobile 
• New diagnosis of T2D within the last 60 
days 
• Hospitalization for mental illness within the 
past 30 days 
• Receiving active chemotherapy and/or 
radiation treatment 
• Diagnosis for Metastatic Cancer 
• Recent hospitalization within the past 60 
days that would influence their diabetes 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 7 of 38 
device to take photos (Aim 3a 
only) 
• A1C ≥ 8.5 (Aim 3b only) 
• Be prescribed insulin (Aim 3b 
only) 
 
 
medication regimen (e.g., myocardial 
infarction, cerebrovascular accident, 
coronary artery bypass grafting, etc.) 
• Currently receiving Kidney Dialysis 
• Limited hearing or speech difficulties that 
influence the Veteran’s ability to complete 
the survey and intervention 
• Dementia, delirium, or other cognition issues 
that influence the Veteran’s ability to provide 
consent and complete the survey. 
• Not currently prescribed insulin (Aim 3b 
only) 
 
Subject Recruitment 
For the purposes of screening, recruiting, and determining eligibility information will be 
obtained through written communication with the prospective participant and/or 
identifiable private information will be obtained by accessing medical records. Potential 
participants will be identified utilizing the VA’s Information and Computing Infrastructure 
(VINCI) Corporate Data Warehouse (CDW) and/or local electronic health record (EHR). 
With approval of a HIPAA waiver, we will initially conduct a data pull with real Social 
Security Numbers (SSNs) from VINCI. In order to identify potential participants, we will 
complete computer-based screening using the VA Corporate Database Warehouse and 
our established inclusion/exclusion criteria. For Aims 3a and 3b, based on protocol we 
will select the appropriate number of participants to be included in each letter batch and 
create the letters for each batch of potential participants. Multiple batches of letters will 
be sent until we reach our recruitment goal. We will send letters to all eligible potential 
participants. An IRB approved letter along with study information documents will be sent 
to the potential participant informing them of the study and providing a phone contact for 
study staff. The Durham, NC Center of Innovation (COIN) will be the site for this study. 
Durham is an appropriate setting for this study because of our COIN’s extensive 
experience with research conduct, our racially and socioeconomically diverse patient 
population, and our use of telehealth interventions to improve diabetes health 
outcomes.  
For Aims 3a and 3b, each week eligible participants will be mailed introductory letters 
that provide basic information about the study and let patients know that a study team 
member will call them to ask whether they are interested in participating. The letter will 
also provide patients with a telephone number they may call to leave a message saying 
they are not interested in participating and do not want to receive a call from the study 
team. Between 5-7 days after the letter is sent, the research assistant (RA), or another 
study team member, will call Veterans who do not opt out to assess interest in 
participation. Veterans who do not opt out will be screened for eligibility. Participants 
contacted will next complete a brief telephone-based screening questionnaire to assess 
eligibility criteria that are not captured in DVAHCS electronic medical records. We will 
only ask a limited number of questions that are needed to determine study eligibility. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 8 of 38 
Once the Veteran is deemed to be eligible for this study, they will be invited to set up a 
meeting to further discuss the project. When patients agree to participate in the TARDIS 
program (Aim 3b), they are asked if they would be amenable to being contacted by 
telephone for a future interview to register feedback regarding their participation in the 
program. We plan to contact only those patients who expressed such interest. We will 
contact potential staff members via telephone or email.  Verbal consent will be obtained 
from patients and staff and will be documented prior to conducting the qualitative 
interviews via telephone. 
For Aim 3a, the photo elicitation study will consist of 3 contacts:  
Contact 1: A study team member will read consent the Veteran, introduce the study to 
the Veteran, and review all study procedures. We anticipate this meeting to last 
between ~60-75 minutes. The Veteran will also complete the Diabetes Distress Scale 
and demographic questions. This meeting will be conducted via telephone. At this 
meeting, the Veteran will be encouraged to email photos to an identified study email 
address prior to the second meeting. Veterans will be asked to take ~10 photos prior to 
the second meeting.    
Contact 2: A study team member will meet with the Veteran via telephone or approved 
video-conferencing software, 10-14 days after the first contact. The study team member 
will discuss photos the Veteran emailed to the study team and the Veteran’s experience 
thus far. We anticipate this meeting to last between ~60-75 minutes. Veterans will be 
encouraged to take additional photos and remit those to the research team via an 
identified study email address prior to the third meeting. Veterans will be asked to take 
~10 photos prior to the second meeting. 
Contact 3: A study team member will meet with the Veteran via telephone or approved 
video-conferencing software, 10-14 days after the second contact. The study team 
member will discuss photos the Veteran emailed to the study team and the Veteran’s 
overall experience completing this research study. We anticipate this meeting to last 
between ~60-75 minutes.  
For Aim 3b, the intervention will consist of up to 3 study contacts, and 3 TARDIS 
contacts (health coach), in addition to the Veteran’s regularly scheduled health care:  
 
Study Contacts. 
Contact 1: A study team member will read the consent to the Veteran, introduce the 
study to the Veteran, and review all study procedures. We anticipate this meeting to last 
between ~60-75 minutes. The Veteran will also complete the baseline measures. This 
meeting will be conducted via telephone. We will obtain baseline data on psychosocial 
factors (depression, PTSD), environmental factors (finances, support), self-
management behaviors, HbA1c and DD. Surveys will enable examination at the 
conclusion of the intervention. We will use the 17-item Diabetes Distress Scale due to 
its stronger associations than the Problem Areas in Diabetes Scale with self-
management challenges, physician-related distress, and clinical outcomes.17 Diabetes 
Distress Scale scores are reported as both a total score and as scores for each of the 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 9 of 38 
four domains.14,32 The Diabetes Distress Scale is reliable and valid in assessing DD in 
diverse populations, the factor structure is stable across sites and populations, the 
measure is parsimonious, and items are clear and readable.8,34,37,38,40 The surveys will 
provide insight into potential facilitators and barriers to DD and T2D self-management 
such as symptom severity, minimal social support, and/or high chronic illness needs. 
We will use these surveys to understand DD, and facilitators and barriers to T2D self-
management, in a sample of Veterans who receive care at Durham.   
Contact 2: A study team member will meet with the Veteran at the conclusion of 
TARDIS and complete the end-of-TARDIS surveys. The surveys will include all surveys 
completed in Contact 1. We anticipate this meeting to last between ~60-75 minutes. 
This meeting will be conducted via telephone. The RA will invite the Veteran to 
complete a qualitative interview to discuss the Veteran’s experience. For those 
Veterans who decline to participate in the qualitative interview no further contact will be 
made.  For those Veterans who accept to participate in the qualitative interview, the RA 
will, based on patient and interviewer availability, schedule the interview to take place 
within the next 2 weeks. 
 
Contact 3. Prior to beginning the qualitative interview, a verbal consent script will be 
reviewed with the participant and verbal willingness to continue participation will be 
captured at the beginning of the audio recording. Recording and transcription of the 
qualitative interviews will be conducted utilizing VA approved software installed and 
configured by VA OI&T personnel.  Audio recordings will be captured using WebEx or 
Microsoft Teams the software to record the audio portion of the patient interviews. 
WebEx or Microsoft Teams recordings will be saved directly to the restricted study 
folder on the R drive. We will use the approved version of Audacity software 
(http://trm.oit.va.gov/ToolPage.aspx?tid =5566#) to edit the audio file in the study folder 
on the HSRD VA project server. We anticipate this meeting to last ~30-45 minutes.  
 
TARDIS Health Coaching Contacts  
 
After enrollment to the study, a TARDIS study team member (HSR&D interventionist) 
will deliver the health coaching to the Veteran. The interventionist will have training and 
experience in motivational interviewing and health coaching. A total of 3 contacts will 
occur over 3 months. The first health coach visit will be scheduled to take place within 
two weeks following enrollment and completion of the baseline surveys.  
 
 
Health Coach Contact #1: Within 2 weeks after enrollment & completion of baseline 
surveys (Duration = ~30 minutes) 
• Discussion around DD and T2DM self-management. Preliminary discussion will 
first focus on the highest, or most prominent, domain of diabetes distress to 
identify key issues related to, or that impact, adherence to T2DM self-
management. The highest domain will be identified by the highest domain score 
for the domain in the survey. If the Veteran has multiple domains of DD with high 
scores (e.g., ‘high’ or ‘moderate’ distress in more than one domain), the 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 10 of 38 
interventionist will work with the Veteran to determine which area to prioritize. 
The interventionist will then inquire about any other pressing issues that may 
impact or influence the DD score, or engagement in T2DM self-management. 
• Identification of a SMART goal  
Health Coach Contact #2: Within 1 month post contact #1 (Duration = ~30 minutes) 
• Discuss Veteran’s concerns or thoughts regarding recommendations, interaction 
with the diabetes educator, and goal made  
Health Coach Contact #3: Within 1 month post contact #2 (Duration = ~20 minutes) 
• Identify if issue was addressed and if Veteran has any continued concerns or 
thoughts regarding recommendations made 
• Discuss Veteran’s concerns or thoughts regarding recommendations, interaction 
with the diabetes educator, and goal made 
 
Consent Process 
For both Aims 3a and 3b, we will request a waiver of written consent, waiver of consent 
documentation and waiver of HIPAA authorization from the IRB to conduct recruitment 
activities described above. Because these interviews represent minimal risk to 
participants and are being conducted remotely by the Durham VAHCS team with 
participating VAMC site patients and staff, we are also requesting a waiver/alteration of 
documentation of written consent and HIPAA Authorization for the conduct of the 
qualitative interviews.  Every effort will be made to talk via telephone with participants in 
privacy of their own home when completing the consent and questionnaires for data 
collection. Participants will be able to indicate to study staff if they are in a private 
environment or if they would like to be called at another time. This will ensure privacy 
and protect against embarrassment of sensitive survey questions and interview details. 
When we speak with patients and staff by telephone, we will obtain verbal consent for 
study participation and to record the qualitative interview. The consent will be 
documented at the beginning of the recording within the study files (audio recording and 
tracking). We will not document the verbal informed consent in the electronic health 
record (EHR). 
Prior to beginning recruitment, the PI will meet with key personnel to review the 
protocol, the informed consent process, and the collection of questionnaires. Research 
study staff will demonstrate the essential steps in how to implement the protocol to 
ensure proper technique is communicated to participants. PI will ensure all study staff 
are up-to-date with required VA security and privacy training. PI will also ensure 
research study data are no longer accessible to study personnel when they are no 
longer part of the research team. 
 
Study Procedures 
For Aim 3a, all participants will participate in the photo elicitation study, there is no 
randomization or groups. For Aim 3b, there is no randomization or groups. After the 
consent process, Veterans will complete a battery of survey questions administered by 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 11 of 38 
the RA.  These surveys will be collected in the study RedCAP survey. In anticipation of 
recruitment challenges, we will use methods: (1) flexible staffing of the PC and RA, to 
recruit and enroll Veterans who have varying work and life commitments; (2) clear 
language in the initial recruitment letter, to indicate the time commitment for the survey; 
(3) using a call schedule developed by the Durham COIN PCs, we will make three calls 
on three different days, at three different times, and leave two messages. We will offer 
Veterans the option of completing the surveys via telephone. 
Variables and data collection methods for the baseline survey.  
Variable 
Measure 
Source 
HbA1c 
Most recent value in the past 180 days 
EHR/CDW 
Diabetes 
Distress 
Diabetes Distress Scale. 17-items that use a 6-point 
Likert scale that measures diabetes distress in 4 
domains: emotional, interpersonal, healthcare provider, 
regimen.14,18,32 Scores indicate low, moderate, or high  
diabetes distress.14 Internal reliabilities of 0.92 - 0.93 
demonstrated.14,18 
PRO 
Demographics 
Age, sex, gender, race/ethnicity, etc. 
EHR/CDW 
Comorbidities 
Current medical diagnoses during the past 180 days 
EHR/CDW 
Medications 
Currently prescribed medications during the past 180 
days 
EHR/CDW 
Depression 
The Patient Health Questionnaire-2 (PHQ-2). A two-
item measure that uses a Likert scale to assess for 
depression.33 Established reliability and specificity for 
assessing depression in adults with diabetes.33 
PRO 
PTSD 
Primary Care PTSD Screen for DSM-5. 5-items that 
identify respondents with probable PTSD in primary 
care settings. Scores “yes” to 3 or more questions is 
considered positive for PTSD. Established reliability 
and specificity.34 
PRO 
Social Needs 
Health Related Social Needs Survey. 10-items to 
assess unmet, health-related social needs in 5 
domains: housing instability, food insecurity, 
transportation needs, utility needs, and interpersonal 
safety.35 
PRO 
Self-Efficacy 
Diabetes Empowerment Scale-Short Form (DES-SF). 
8-items to assess diabetes related self-efficacy. 
Demonstrated validity and reliability.36,37 
PRO 
Self-
Management 
Behaviors 
We will use either one of these scales to assess self-
care activities:  
Summary of Diabetes Self-Care Activities. We will use 
the core 11-items that measure completion of T2D self-
care behaviors in the past seven days. Validity and 
reliability have been demonstrated.38  
 
Self-Care Inventory-Revised Version (SCI-R). We will 
PRO 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 12 of 38 
 
For both Aims, those identified for the studies will be invited to complete the semi-
structured interviews. If patients decline to participate in the study no further contact will 
be made.  For both aims, for those who, accept the invitation, the RA will, based on 
patient and interviewer availability, schedule the interview to take place within the next 2 
weeks. For aim 3a, prior to beginning the first meeting, a verbal consent script will be 
reviewed with the participant and verbal willingness to continue participation will be 
captured at the beginning of the audio recording. For aim 3a, at the conclusion of 
meeting 1, the qualitative analyst will schedule an appointment for meeting number 2. 
For aim 3a, at the conclusion of meeting 2, the qualitative analyst will schedule an 
appointment for meeting number 3. For aim 3a, at the beginning of meetings 2 and 3, 
the qualitative analyst will review the verbal consent script with the participant and 
verbal willingness to continue participation will be captured at the beginning of the audio 
recording. For aim 3b, at the end of the intervention, a verbal consent script will be 
reviewed with the participant and verbal willingness to continue participation will be 
captured at the beginning of the audio recording. Recording and transcription of the 
qualitative interviews will be conducted utilizing VA approved software installed and 
configured by VA OI&T personnel. Audio recordings will be captured using WebEx as 
the software to record the audio portion of the patient interviews. WebEx recordings will 
be saved directly to the restricted study folder on the R drive. We will use the approved 
version of Audacity software (http://trm.oit.va.gov/ToolPage.aspx?tid =5566#) to edit the 
audio file in the study folder on the HSRD VA project server.  
For aim 3a, in order to participate in this study, the Veteran will email photos taken on 
their personal device to a VHA study email address. The project coordinator, qualitative 
use the core 15-items that measure completion of 
T2DM self-care behaviors in the last 1-2 months. 
Validity and reliability have been demonstrated.39 
Stigma, shame 
PROMIS Neuro Quality of Life Short Form Stigma. We 
will use the 8-item stigma short form. Validity and 
reliability have been demonstrated.40 
PRO 
Pain and 
physical activity 
PROMIS Pain Interference – (Short Form 6a). We will 
use the 6-item scale to examine pain interreference on 
daily life. Validity and reliability have been 
demonstrated.41  
PRO 
Life stresses 
Confusion, Hubbub, and Order Scale42. We will use the 
core 15-items that measure life chaos. Validity and 
reliability have been demonstrated in Veteran 
populations.43,44  
PRO 
Note: EHR/CDW=electronic health record/corporate data warehouse, data will be 
obtained by the RA upon study enrollment prior to the survey completion; PRO=patient 
reported outcome, data will be obtained via survey/interview. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 13 of 38 
analyst, research fellow (Dr. Roman Jones), and study PI (Dr. Lewinski) will have 
access to this email address. They will follow these procedures to ensure data safety 
and accuracy: (1) the project coordinator will check the email box each day; (2) if there 
is an email from a participant, the project coordinator will save the photos into a folder 
with the participant’s study ID; (3) the project coordinator will notify Dr. Lewinski; Dr. 
Lewinski will then verify the photos are saved into the correct participant’s folder on the 
R drive; (4) Dr. Lewinski will notify the project coordinator with a final result. The 
qualitative analyst and the research fellow will have the ability to email participants 
directions to log into the video conference call or for other study matters relating to 
viewing photos to discuss during the qualitative interviews.  
For aim 3b, each intervention component will be administered by an HSR&D 
interventionist, as would be the case in real-world practice. TARDIS interventionists will 
complete training during a single session, which will be led by the study PI, with follow-
up/refresher sessions as needed. The interventionists will receive an email or hardcopy 
(depending on their preference) of the TARDIS intervention manual containing study 
materials and procedures and will use online software to track intervention activities 
(e.g., attempted/ completed phone calls, modules delivered, medication changes). 
TARDIS research staff will not participate in intervention delivery, but will manage only 
study-specific tasks like enrollment, randomization, and outcome assessment. Of note, 
while receiving TARDIS, study participants will continue to receive care from primary 
care and other VHA providers.  
The TARDIS interventionist will deliver the intervention components during telephone 
encounters according to a schedule (see intervention schedule). Each encounter will be 
documented in an intervention database, and/or in the EHR. We will allow for flexibility 
in the encounter schedule for patients based upon the Veteran’s response to 
introduction questions at the beginning of each contact. Examples of the introduction 
questions are listed below; however, the wording of these questions may differ slightly 
based upon the conversation and interaction with the Veteran:  
1. How is your diabetes routine going?  
2. In general, is your diabetes routine changing or limiting your life activities?  
a. If yes: what makes you get thrown off your routine? How do you 
handle that when it happens?  
3. Are there any questions you have, or things you want to discuss, in 
regards to your diabetes self-management?  
At the end of the encounter, the interventionist will ask one question and provide one 
comment. Examples of the question and comment are listed below; however, the 
wording of these may differ slightly based upon the conversation and interaction with 
the Veteran:  

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 14 of 38 
1. Do you have questions about anything we have covered as part of today’s 
session?   
2. Now, I would like to share a [resource, encouragement, tip] based on something 
we discussed today. 
In response to question #1, the interventionist will review the goal setting process as 
requested by the Veteran. In response to question #2, the interventionist will share 
either a resource, encouragement, or tip based on material discussed during the 
encounter. 
The standard encounter frequency will be approximately every 30 days. 
Intervention components are described below:  
1. Identifying the Domain of Distress. We will identify the DD domain to target for 
the TARDIS intervention using the Diabetes Distress Scale (DDS). We will then 
identify, for that domain, the specific area of the Veteran’s DD to target the 
intervention. In that discussion we will identify barriers to adherence/engagement 
to T2DM self-management and discuss ways to address this specific domain of 
distress using a person-centered approach.  
2. Goal Setting & Connecting to Reduce Distress. Identify a SMART goal that 
addresses the Veteran’s DD (or other barriers to engagement in T2DM self-
management) to address during TARDIS and connect the Veteran to the diabetes 
educator and resources that may support the Veteran’s goal. The TARDIS 
Interventionist will refer the Veteran to resources and referrals (as able within 
scope). 
3. Assessment. Determine completion of goals and acceptability of information and 
resources shared with Veteran. If the Veteran needs additional support or 
information, the TARDIS interventionist will contact the diabetes educator via 
secure VA approved software (Microsoft Teams and/or encrypted email) and/or 
make a note in the patient’s EHR.  
 
The TARDIS interventionist’s actions after the 1st and 2nd Visits with Veteran include: 
1. Create order within electronic health record (as able within scope): refer Veteran to 
appropriate VA resources 
2. Document the encounter in an intervention database and/or the EHR: summarize 
discussion with the Veteran, describe the SMART goal set, follow-up plans, and 
resources provided.  
3. Contact the diabetes educator: Using secure VA approved  software and/or add 
the diabetes educator and Veteran’s PACT RN to the note. 
 
The TARDIS interventionist’s actions after the 3rd Visit with Veteran include: 
1. Create order within electronic health record (as able within scope): refer Veteran to 
appropriate VA resources 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 15 of 38 
2. Document the encounter in an intervention database and/or the EHR: summarize 
discussion with the Veteran, describe the SMART goal set, follow-up plans, and 
resources provided.  
3. Contact the diabetes educator: Using secure VA approved software and/or add the 
diabetes educator and Veteran’s PACT RN to the note. 
 
Aim 3b. TARDIS Intervention Follow-Up 
Veterans will receive their assigned intervention for 3 months. Within one month after 
(by 4 months), the Veteran will complete a battery of follow-up surveys. The estimated 
time required for the 4-month visit is ~60-75 minutes. At study completion, the TARDIS 
study team will obtain HbA1c data from the EHR.  
Participants that agreed to a future interview at the outset of their participation in the 
TARDIS program will be contacted via telephone, as will participating staff. At a 
minimum, we will include a brief summary of the study at all points of contact. Prior to 
beginning the qualitative interview, a verbal consent script will be reviewed with the 
participant and verbal willingness to participate will be captured at the beginning of the 
audio recording. The verbal consent will also be documented in the local study files. A 
study team member will put a consent note into the EHR to document that the patient 
has been consented and enrolled in a research study. If patients decline to participate in 
the qualitative interview no further contact will be made. Those who agree to be audio 
recorded will be recorded. Recording and transcription of the qualitative interviews will 
be conducted utilizing VA approved software installed and configured by VA OI&T 
personnel. Audio recordings will be captured using WebEx or Microsoft Teams as the 
software to record the audio portion of the patient interviews. When available, WebEx or 
Microsoft Teams interviews will be auto-transcribed verbatim by the software’s auto-
captioning process. WebEx or Microsoft Teams recordings will be saved directly to the 
restricted study folder on the R drive. We will use the approved version of Audacity 
software (http://trm.oit.va.gov/ToolPage.aspx?tid =5566#) to edit the audio file in the 
study folder on the HSRD VA project server. As is the case with any research subject, 
patients may decline to answer any individual questions during the interview. It is also 
anticipated that the participant may miss a scheduled telephone call or may need to 
reschedule the interview at a more convenient time. We will not consider these to be 
protocol deviations since schedule changes will not impact participant's healthcare or 
impose any risks. We anticipate that conduct of each patient and staff interview will last 
~30-45 minutes for patients, and ~25 minutes for staff.  For patients, interviews will 
address their experiences with the program (see Appendix 1 for our patient interview 
guide). For staff, interviews will address their experiences with the program (see 
Appendix 2 for our staff interview guides). 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 16 of 38 
Adverse Events 
Risks to participants will not exceed those associated with usual care. There are no 
hazards associated with the study protocol; however, there are several hazards that 
could potentially occur to the adult population with type 2 diabetes and include sickness 
or infection, hospital admissions, falls, etc. Dr. Lewinski is a licensed registered nurse 
and will be involved in every aspect of the study. Any concern about patient health 
status will be communicated to Dr. Lewinski by study staff. Dr. Lewinski will maintain 
close contact with Dr. Crowley (a licensed VA-credentialed endocrinologist) to discuss 
and obtain guidance on clinical matters and concerns. Dr. Lewinski will maintain close 
contact with Dr. Bosworth to discuss and obtain guidance on intervention 
implementation. The PI will work closely with the research coordinator throughout the 
study to identify individual hazards, if any occur. The PI will be notified of any hazard 
that occurs and will determine if the participant should be removed from the study. If it is 
agreed that the subject be removed, the PI and research coordinator will explain to the 
participant why it is in her best interest to withdraw from the study. The participants will 
be assured that nothing related to her during the study will affect any medical care in the 
future. 
 
For Aim 3a, Veteran photos could potentially include images that indicate the Veteran is 
in personal distress and there is a concern for their safety. Given that we propose 
contacting a small group of patients for this photo elicitation study, we will not utilize a 
Data Safety Monitoring Board. All adverse events will be reported per Durham VAMC 
requirements. All Serious, Unanticipated and Related adverse events will be reported to 
IRB within 5 business days of hearing of the event. All other adverse events will be 
reported at continuing review.  
For Aim 3b, because TARDIS is a self-management and support intervention that 
utilizes approaches that are common in standard practice, we anticipate that adverse 
events will be similar to standard care in quality and rate. Veterans in TARDIS will 
maintain regular participation in their routine VHA health care and the interventionist 
and will be encouraged to report all adverse events (e.g., hypoglycemia, reactions to 
commonly-used diabetes medications) to their VHA healthcare team. Due to the age 
and comorbidities of our study cohort (e.g., risk of vascular disease, existing 
depression), hospitalizations and other health events (e.g., development of new medical 
conditions, surgeries, ER visits, MI, stroke, falls and death) unrelated to the study are 
expected. Any events that fall into one of these categories will be reported at continuing 
review/per the current SOP. Participants may miss study encounters or follow-up 
assessments during the conduct of the project. We will not consider such events to be 
protocol deviations, as they will not impact participants’ healthcare or impose any 
additional risks. At study outset, Veterans will be instructed to seek immediate 
emergency services for any adverse events that require urgent in-person evaluation. As 
some recruited patients may have diagnosed or undiagnosed depression, all patients 
will be given the national suicide hotline number at study outset for use as needed. 
Given that we propose contacting a small group of patients for a telephone interview, 
we will not utilize a Data Safety Monitoring Board nor will we ask patients about adverse 
events that do not pertain to their study participation. The primary risk in this study is a 
loss of confidentiality. Protection of patients’ privacy is addressed in the “Privacy, 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 17 of 38 
Confidentiality, and Information Security” section. All adverse events will be reported per 
Durham VAMC requirements. All Serious, Unanticipated and Related adverse events 
will be reported to IRB within 5 business days of hearing of the event. All other adverse 
events will be reported at continuing review.  
 
Costs and/or Payments to Subjects 
There will be no cost to participants for care they receive as a participant in the VA 
research project.  
For Aim 3a, we will compensate participants for their time. Veterans will receive a direct 
deposit /check by mail from the VA for $30 four to six weeks after completing the 
consent and introduction process to the study. If participants complete the second 
discussion to discuss photos, they will receive a direct deposit/check by mail from the 
VA for $30 four to six weeks after completion. If participants complete the final interview 
to discuss photos, they will receive an additional $40. The total amount participants can 
receive through the study is $100. If participants withdraw from the study early, they will 
be paid for the interviews they have completed. We will use the current established 
process for providing compensation to patients at this facility. 
For Aim 3b, we will compensate participants for their time. Within four to six weeks after 
completing the activities below, Veterans will receive a direct deposit /check by mail 
from the VA. The total amount participants can receive through the study is $135.  
• Completion of Baseline Surveys: $45 
• [if agreed to participate] Completion of Qualitative Interview: $45 
• Completion of Surveys at 4 months: $45 
 
If participants withdraw from the study early, they will be paid for the study contacts they 
have completed. We will use the current established process for providing 
compensation to patients at this facility. 
 
Data and Safety Monitoring 
For Aim 3a, because risks to subjects will not exceed usual care, and all subject contact 
takes place within the context of discrete qualitative interviews, no Data Safety 
Monitoring Board will be utilized. The PI assumes responsibility for monitoring all data 
and safety information collected during the conduct of the program evaluation described 
in this research proposal.   
 
For Aim 3b, medical risks associated with study participation is similar to standard 
diabetes care. TARDIS will include health coaching, which is available as part of 
standard VHA care for Veterans. It is possible that health coaching may increase the 
risk of negative psychosocial outcomes (e.g., distress, depression). However, all 
Veterans will continue to receive their normal VHA care, so risks will not exceed 
standard care. Of note, patients will be referred to the diabetes educator. Because the 
diabetes educator is uniquely suited to identifying and managing hypoglycemia and 
other therapeutic risks in Veterans with diabetes, overall detection and amelioration of 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 18 of 38 
medical risks could actually be enhanced relative to standard care. Further, all Veterans 
will continue to receive their regular VHA care with PCPs and other providers during the 
study, which will provide an added layer of risk protection. At study outset, Veterans will 
also be instructed to seek immediate emergency services for any adverse events that 
require urgent in-person evaluation. Risks specifically associated with study procedures, 
such as completing surveys and qualitative interviews, are minimal. As with any study, 
risk exists for breach of confidentiality and loss of protected health information (PHI), but 
steps will be taken to minimize this risk as per the “Privacy and 
Confidentiality/Information Security” section below. Direct benefits associated with study 
participation may include improved diabetes control. Improved control could translate to 
reduced rates of future complications (which are particularly common for Veterans with 
poorly controlled T2DM). Veterans may also experience reduction in distress and 
improved control of depressive symptoms. Potential benefits to study subjects include 
improved glycemic control and avoidance of future diabetic complications. Benefits for 
Veterans not enrolled in this study may include the development of an effective, 
practical treatment option for Veterans with diabetes distress and poorly controlled 
T2DM, which is currently not available within or beyond VHA. 
 
For Aim 3b, because risks to subjects will not exceed usual care, the proposed 
qualitative study is small and limited to program participants, and all subject contact 
takes place within the context of discrete qualitative interviews, no Data Safety 
Monitoring Board will be utilized. The PI assumes responsibility for monitoring all data 
and safety information collected during the conduct of the pilot trial described in this 
research proposal. 
 
For both Aims 3a and 3b, one aspect of our data and safety monitoring plan will involve 
reporting to the principal investigator and DVAHCS IRB. Study team members who 
become aware of any adverse event related to the study (who can include the research 
assistant, project coordinator, and qualitative analyst) will notify the principal 
investigator, Dr. Lewinski, immediately. Safety monitoring for adverse events (AEs) will 
be conducted in real time by Dr. Lewinski and/or the project coordinator. Dr. Lewinski 
will report all adverse events to Drs. Bosworth and Crowley. The following information 
about AEs will be collected: 1) the onset and resolution of the AE, 2) an assessment of 
the severity or intensity (use existing grading scales whenever possible), 3) an 
assessment of the relationship of the event to the study (definitely, probably, possibly or 
not related), and 4) action taken (e.g., none, referral to physician). The PI, in 
consultation with Dr. Bosworth (primary mentor) and Dr. Crowley (secondary mentor) 
will determine the severity of the event, will assign attribution to the event, and will 
monitor the event until its resolution. Any adverse events will be reported to the IRB in 
accordance with the local Human Research Protection Program’s Standards of 
Practice. Reports of non-serious AEs are required as part of these progress reports.  
For both Aims 3a and 3b, study team members will have contact information for Dr. 
Lewinski for evening/weekend hours. (Most study activities will occur during regular 
business hours, but some participants may request to be contacted for a screening 
interview during evening or weekend hours.) If Dr. Lewinski is not available for contact 
when a study team member becomes aware of a study-related AE, Dr. Bosworth (Dr. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 19 of 38 
Lewinski’s primary mentor) or Dr. Crowley (Dr. Lewinski’s co-mentor), will be contacted. 
Once Dr. Lewinski (or Dr. Bosworth or Dr. Crowley) is contacted about the AE, she/he 
will decide about the reporting requirements in accordance with the DVAHCS IRB 
guidelines.  
For both Aims 3a and 3b, Dr. Lewinski will meet at least weekly with study personnel to 
discuss participants’ reactions to the survey/interviews and any AEs or unanticipated 
problems. Dr. Lewinski will also meet weekly with Dr. Bosworth (primary mentor) and 
biweekly with Dr. Crowley (co-mentor). Monthly meetings between the investigators and 
the project coordinator will allow for ongoing progress reports, including the number of 
participants currently involved in the study, attrition rates, and scheduled data collection 
from participants, as well as notification and review of any AEs. All individuals involved 
in the study will develop and implement methods of verifying entered data and of quality 
control. 
Data management 
Study tracking data will be entered into an intervention database and stored 
electronically using VA REDCap (Research Electronic Data Capture) which is a web-
based application hosted on the VA Enterprise Cloud and is available only on the VA 
network. This database will allow us to track: patient study status (i.e., eligible, enrolled, 
refused); the results of screening interviews; intervention tasks due for each participant; 
and encounter-specific data (e.g., attempted/completed phone calls, duration of phone 
encounters, modules delivered, medication changes). Screening and outcome 
measures will also be entered directly into the study database using RedCAP. RedCAP 
will be hosted on the VINCI servers.  Data will be stored in a restricted folder on a 
secure VHA server. 
 
Integrity of study data 
Accuracy and integrity of study data will be ensured in two ways. First, the 
Durham VHA COIN conducts computer operations in a secure Centralized Computing 
Facility managed by VHA network and server administrators. Within this computing 
facility, all research data are stored on VHA-Administered servers, which are physically 
secured in the Durham VAMC computer room. VHA network access to research data is 
controlled in accordance with the COIN’s standard operating procedures and VHA 
policies. In addition, standard COIN procedures ensure that servers, workstations and 
portable computers are kept up-to-date with virus filters, security patches, software 
updates and firmware updates. 
 
Future Data Use  
For Aims 3a and 3b, we may want to run secondary data qualitative and quantitative 
analyses related to the original aims of the grant (e.g., mediator/moderator analyses, 
analyses of baseline data, etc.). We will also track referrals (number, type, etc.) in 
CPRS and/or CDW that each participant has completed at 3 and 6 months subsequent 
to the final session of their intervention. It is also possible that data collection under this 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 20 of 38 
proposal might be used to inform future surveys, interviews, and/or intervention 
development among patients with diabetes. We may also want to review the patient’s 
A1C value approximately 3 months after the completion of the patient’s involvement in 
TARDIS to inform future studies, interviews, or intervention development. Data would 
only be used from patients who agreed that their data could be stored and used for 
future analysis. A de-identified data set from the variables obtained for the project will 
be created.  A separate protocol, defining the possible new project(s) would be 
submitted to the Durham VA IRB. These future studies would request either a 
waiver/alteration to the ICF/HIPAA requirements or a consent form and updated HIPAA 
Authorization, as appropriate.  
Withdrawal of Participants 
VA Patients who no longer want to participate in Aims 3a or 3b may inform the staff.  
The staff will document that change in status, so they are not prompted to contact the 
patient in the future. For Aim 3b, patients who do not wish to continue TARDIS may 
inform the interventionist and/or the TARDIS study staff. Study staff will remove 
document the change in status. Veterans who choose to withdraw from TARDIS will 
continue to receive care as normal.   
For Aims 3a and 3b, patients may be withdrawn from the research study without their 
consent under the following conditions (also previously listed as exclusion reasons): 
1. Inability to communicate by telephone  
2. New diagnosis of dementia or psychosis  
3. Active alcohol or substance disorder  
4. Current report of new pregnancy during study  
5. New instance of hypoglycemic seizure or coma  
6. HbA1c value < 8.5% at baseline study assessment 
Patients who choose to withdraw from the study after enrolling will be asked to provide 
written documentation of the request to the study team.  If a patient withdraws, no new 
data will be collected about him/her, other than a possible reason for withdrawal.  All 
data collected prior to the date of withdrawal will remain with the study files and may be 
used for analysis. 
 
Data Analysis and Statistical Considerations 
Aim 3a – Photo Elicitation Interviews.  
Audio recordings will be transcribed by the DVAHCS staff or VA approved transcription 
service. When transcribed, names and other identifying information will be redacted. 
Transcripts will be saved in the secured VA project drive 
(\\v06.med.va.gov\DUR\HSRD\TARDIS-Photo). We will use a convenience sampling 
plan to recruit ~12 Veterans with T2D who receive care at the Durham VA. The 
preferred method of data collection will be: (1) telephone or video-conferencing software 
(E.g., WebEx). Interviewing Veterans via the telephone may decrease barriers to 
participation (e.g., access, time, transportation); and (2) patient-generated health data in 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 21 of 38 
the form of photographs taken by the Veteran on their personal device and emailed to a 
study email address.  
Photo elicitation guided semi-structured interviews will enable us to further understand 
DD in the context of T2DM self-management. Interviews will be conducted by a 
qualitative analyst, will last 45-60 minutes, and will be recorded as permitted by the 
Veteran. If the Veteran does not consent to being recorded, the qualitative analyst will 
take detailed notes throughout the interview. We will use an interview guide to elicit 
Veterans’ photos in the context of DD and T2DM self-management.  Prior to meetings 2 
and 3, the qualitative analyst will review the photos taken by that participant. The 
qualitative analyst will then open these photos to guide the discussion with the Veteran.  
We will use verbal probes as a way to elicit Veteran’s answers.45-47 The use of 
concurrent (e.g., to assess real-time thoughts and feelings about DD and their photos) 
and retrospective (e.g., to assess thoughts of taking photos at interview completion) 
probes will enable us to obtain specific and global feedback on DD and the photo 
elicitation method.45 During the interview, we will encourage the Veteran to describe the 
context depicted in the photo, what prompted them to take the photo, and any thoughts 
about the images in the photo.  
Analysis Plan.  
Aim 3a 
We will begin analysis after the first three interviews and preliminary analysis will guide 
future data collection.48 Each interview will be transcribed and identifying information will 
be removed. Limited demographic information (e.g., gender, medication) will be noted 
within the transcript to facilitate consideration of the Veteran’s responses. We will use 
thematic analysis with the software NVivo for this study.49  
A coding team consisting of Dr. Lewinski and the qualitative analyst will code these 
data. They will meet weekly during interviewing, coding, and analysis to identify 
emerging areas, refine the interview guide, and address emergent questions. The 
coding team will independently read all transcripts to become familiar with these data; 
the coding unit for each a priori code will be a response to an item. The coding team will 
independently create examples from the transcripts for the a priori codes, and any 
emergent codes, for 20% of the transcripts, and then meet to discuss codes and coding 
units. We will compare examples and discuss findings until agreement is reached on 
coding definitions and application of the definitions to these data. The coding team will 
repeat the described process until we have total agreement on the first level coding; 
following discussions, the coding team will re-code transcripts using any new codes. 
The coding team will identify and create higher level codes based upon created and 
agreed upon codes after the completion of first level coding and discussion of 
preliminary findings with the co-mentors. Second level coding will mirror the first level 
coding approach in that the coding team will independently code 20% of the transcripts 
and meet to discuss emerging patterns. To ensure reliability and validity of the coding 
process and the creation of these descriptive summaries, the coding team will meet 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 22 of 38 
weekly to compare coding and resolve disagreements. All findings will be discussed and 
reviewed with other study team members to ensure reliability and validity.  
Primary outcome: Interviews and photos will provide insight into how the Veteran 
interprets DD, T2DM self-management, and the associated challenges/strategies with 
self-management.  
Aim 3b 
TARDIS is a pilot study to assess feasibility and acceptability; thus, the most critical endpoints are 
related to recruitment, retention, feasibility, and acceptability of the intervention. Collection of 
detailed process data (e.g., phone calls attempted and completed, length of calls, number of 
services utilized via EHR and Veteran self-report) is critical. Additionally, we will collect 
outcomes that we anticipate using in a future application such as HbA1c, diabetes distress 
score, self-efficacy for diabetes self-management, and self-management behaviors. A formative 
evaluation will enable us to make modifications to TARDIS prior to the implementation of the 
intervention in a larger, randomized trial.  
 
Feasibility. We operationalize feasibility as demand for, and practicality of, TARDIS.50 
We will assess the feasibility using: (1) recruitment data (e.g., number of Veterans 
eligible, approached, and enrolled in TARDIS); (2) process data specific to Veterans 
(e.g., phone calls attempted and completed, length of phone calls, number of services 
utilized via EHR and Veteran self-report, participation and retention during TARDIS); 
and (3) process data specific to TARDIS (e.g., methods of delivery, nurse interventionist 
time/effort). Length and duration of TARDIS calls and interactions with interventionist 
(number of contacts suggested, number of contacts completed). Length and duration of 
TARDIS calls with diabetes educator (number of contacts suggested, number of 
contacts completed). Process measures (length of time between interactions). Referrals 
(referrals made, referrals completed, mean time to referral completion). Semi-structured 
interviews will enable us to obtain data on the amount and type of resources needed; 
perceived negative/positive effects, and perceived demand for TARDIS. 
Acceptability. Semi-structured interviews with Veterans will elicit responses about: (1) 
intervention components and delivery; (2) participation challenges; (3) suggestions 
regarding future iterations of TARDIS; (4) quality of referrals made during TARDIS. 
Semi-structured interviews with the TARDIS intervention staff will elicit responses about: 
(1) intervention components; (2) delivering TARDIS via telephone; (3) interactions with 
the Veterans; (4) overall impression of the intervention; (5) suggestions for changes to 
TARDIS; and (6) appropriateness and fit of TARDIS within VA organizational structure. 
We will then present the TARDIS findings and TARDIS staff responses to our local and 
national stakeholders to obtain further insight into acceptability of TARDIS at VA. The 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 23 of 38 
review of TARDIS summary notes from Veteran’s EHR and interventionist debrief notes 
will provide insight into the content of the TARDIS sessions.  
Statistical analysis. These data to examine feasibility and acceptability will be primarily 
descriptive and qualitative. Feasibility measures will be assessed as proportion of 
Veterans meeting a retention rate of 80% of all sessions and completing 80% of the 
suggested connections to supportive services. We will also calculate descriptive 
statistics on the process data. For the outcome variables to be used in a future study, 
we will calculate descriptive statistics at each time point and the difference between 
baseline and 4-months. Finally, we will calculate the effect size of the difference 
between baseline and 4 months, with corresponding 95% confidence intervals to 
provide information about the possible range of effect sizes and to compare magnitude 
of changes across different measures.51 Acceptability data of semi-structured interviews 
with the Veterans and the TARDIS nurse will be analyzed using methods described 
below.  
Sample size considerations. Our target enrollment is 20 Veterans, over 12 months. A 
power calculation will not be performed given that we are not evaluating statistical 
significance in the TARDIS pilot study. Rather, we are seeking an indication of feasibility 
and acceptability to evaluate our TARDIS pilot protocol. A sample size of 20 Veterans 
will provide sufficient input to inform intervention refinement and improvement for a 
larger RCT under the limitations of a time period and funding resources. 
Potential problems and solutions. Potential problems include retention of Veterans and 
maintaining up-to-date supportive materials. We will keep detailed notes on each 
Veteran encounter during TARDIS. We will keep a logbook of actions the interventionist 
and diabetes educator have taken, so that if the interventionist or diabetes educator 
changes mid-intervention, we can maintain continuity of care. To ensure that the 
information we provide to Veterans is correct, we will work to maintain an up-to-date 
listing of resources in VA and community. To decrease attrition, we will use successful 
retention strategies previously used by our team. 
 
Qualitative Interviews:  
The preferred method of data collection will be via telephone. Interviewing Veterans and 
staff via the telephone may decrease barriers to participation (e.g., access, time). Semi-
structured interviews will be completed by a Qualitative Analyst. We will develop an 
operating manual for the interviews, review interviewing techniques that encourage 
openness, and review active listening techniques.52,53 Prior to the first Veteran and staff 
interview, we will practice interviewing to ensure the qualitative analyst is familiar with 
the interview guide and purpose of the interviews. We will observe the qualitative 
analyst for the first 2 interviews to ensure she is using the interview guide correctly, and 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 24 of 38 
then we will listen to recordings of every fourth interview to ensure that the qualitative 
analyst is following the interview guide. 
Analysis Plan. We will begin analysis after the first two interviews and preliminary 
analysis will guide future data collection.48 The analysis process will be iterative, as 
initial analysis will inform interview guide questions.48 A coding team consisting of Dr. 
Lewinski and qualitative analyst will code these data. They will meet weekly during 
interviewing, coding, and analysis to identify emerging areas, refine the interview guide, 
and address emergent questions. All transcripts will be de-identified and will not contain 
information about Veteran’s engagement in TARDIS, HbA1c level, or DD score to 
ensure objectivity during coding and analysis. Throughout coding and analysis, findings 
will be discussed with the study team and mentors to ensure reliability and validity of the 
interpretation. The coding team will use thematic analysis with the software NVivo. The 
analysis plan will occur in two steps. First, the transcribed text from the interviews will 
be coded and analyzed for aggregate themes specific to DD and T2D self-management. 
Then, using matrices, we will identify similarities and differences between levels of DD, 
engagement in TARDIS, and participant characteristics. While we will code and analyze 
the patient and staff interviews separately, we will follow the procedures described 
below for analysis.  
 Analysis Plan: Step 1. First, we will upload the transcripts into NVivo and then begin 
coding. First level coding will be guided by a priori codes based upon how Veterans 
describe DD and feasibility and acceptability of TARDIS. Emergent codes about DD, 
T2D self-management, and engagement in TARDIS will be identified in relation to 
observations of self-management unique to Veterans. Codes will be examined in the 
context of DD and self-management of T2D to focus the analysis.54 The coding team 
will independently read all transcripts to become familiar with these data, and then 
identify appropriate coding units for each a priori code prior to beginning coding. The 
coding team will independently create examples from the transcripts for the a priori 
codes, and any emergent codes, for 20% of the transcripts, and then meet to discuss 
codes and coding units. We will compare examples and discuss findings until 
agreement is reached on coding definitions and application of the definitions to these 
data. The coding team will repeat the described process until we have total agreement 
on the first level coding; following discussions, the coding team will re-code transcripts 
using any new codes. The coding team will identify and create higher level codes based 
upon created and agreed upon codes after the completion of first level coding and 
discussion of preliminary findings with the co-mentors. Second level coding will mirror 
the first level coding approach in that the coding team will independently code 20% of 
the transcripts and meet to discuss emerging patterns. We anticipate that a 
multidimensional structure will be present in these data, thus no limit will be placed upon 
codes to which a coding unit can be assigned. 
Analysis Plan: Step 2. We will begin Step 2 once we identify the overall themes for 
the entire data corpus. We will use the co-occurrence feature in NVivo and explore the 
findings in matrices to identify patterns of similarities and differences. To enable the 
analysis in Step 2, we will first label each transcript in NVivo with the Veteran’s HbA1c 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 25 of 38 
level, engagement, and Diabetes Distress Scale score. Dr. Lewinski has previously 
used the co-occurrence feature to identify points of similarities and differences.55 
Validity and reliability. Validity and reliability of findings and the iterative generation of 
codes will be ensured by working closely with qualitative analyst and the research 
team.54 The coding team will: provide rich descriptions of all codes and themes; discuss 
coding until consensus is reached for each code and theme; triangulate data from 
quantitative and qualitative sources; and present any discrepant information.54 The 
codebook will describe the codes and emerging themes and serve as an audit trail. 
Regular meetings with the study team will ensure validity and reliability, higher level 
code development, and discussion of emerging findings.  
Privacy and Confidentiality/Information Security 
For Aims 3a and 3b, our experienced team has a strong understanding of 
research-associated risks and will take all necessary measures to protect patients at 
both study sites. Data security for this project will be overseen by the Durham COIN 
Computer Science specialist. The Durham COIN has developed standard operating 
procedures for data acquisition and data management, which are designed to protect 
against data loss and maintain patient confidentiality. These procedures have been 
used in many studies and we will adhere to these procedures at both sites for the 
proposed study.  
All participant information collected in the context of this research study, even the 
fact that an individual is participating in the study, will be considered confidential, and 
the study team will take steps to ensure the participant’s confidentiality is protected at 
each step of the research process:  
• Each participant will be assigned a study identification number (ID), which links 
all computerized research records; all research data files are organized by study 
ID, with no names or other identification attached.  
• All PHI will be housed on a secure server behind the Durham VAMC firewall at 
both sites, and access will be restricted. Computerized study data will be 
maintained on VHA network servers which are secured behind a firewall (as well 
as through controlled physical access). Server access is controlled by the 
computer specialist at the Durham COIN, and staff members will only be allowed 
access to data pertinent and authorized for their role. All study forms and paper 
records that contain participant information will be kept in secured, locked areas 
when not in use, accessible only to appropriate personnel; when in use, these 
materials will be kept from public view.  
• For qualitative interviews, staff will use a VHA encrypted laptop in conjunction 
with WebEx audio recording device to record interviews, which will then be saved 
on the encrypted computer, immediately uploaded to a restricted folder on the 
VHA server network, and then removed from the laptop. We will remove 
identifiers from the file names and interview notes.  
• All study personnel will maintain IRB research certification, with special training in 
research ethics. This training includes detailed instruction on confidentiality.  

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 26 of 38 
• Participants will not be identified by name in any reports or publications, nor will 
data be presented in such a way that the identity of individual participants can be 
inferred. All information obtained in the course of the study that identifies an 
individual will be treated as confidential in accordance with section 903C of the 
Public Health Service Act (42 U.S.C.299a-1). We will strip all identifiers from 
analytic data sets after data merging, and keep all personal identifiers in a 
separate location from the analytic data. Database files needed to generate 
mailing labels will contain no research data.  
 
 
Privacy, Confidentiality, and Information Security 
1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and 
Conduction of Study:  
The Personal Health Information that will be obtained, used,  and/or shared for this 
study includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 
 All geographic subdivisions smaller than 
a State, including street address, city, 
county, precinct, and zip code.  Describe: 
street address, City, Zip, County 
 Photographs, videotapes, 
audiotapes, or digital or other images 
 All elements of dates (except year) for 
dates directly related to an individual, 
including birth date, admission date, 
discharge date, visit or treatment dates, etc.; 
and all ages over 89, Describe: birth date, dx 
dates, admission date, discharge date, visit 
or treatment dates, RX dates, lab dates, 
survey dates 
 Biologic specimens (e.g., blood, 
tissue, urine, saliva). Describe: 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators 
 Drug abuse information 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 27 of 38 
Identifier(s) 
Source(s) of Health Information 
(URLs) 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) 
notes 
 Biometric identifiers, including finger & 
voice prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
characteristic, or code, describe :  
Anonymous/Randomly assigned study ID#  
*Note: This is not the unique code assigned 
to otherwise de-identified health information 
for re-identification purposes. 
 Other, describe:        
 
 
2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants.  Provide 
description of processes:  We will collect information from patients using telephonic 
survey collection methods, patient generated photographs, and WebEx conference 
communications. Patients will email patient generated photographs to the study email 
address. The study team will check the study email daily and immediately save the 
patient generated photos to the study folder. 
  Retrospective data collection and/or specimens obtained from medical chart 
review/data access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):   
We will use the current VA CDW/VINCI resources to identify the necessary participants 
with the requested inclusion/exclusion criteria. Using the real SSNs from that subset, we 
will retrieve current mailing addresses, telephone number, as well as the specific 
medical record data (using approved VA data bases) via the VHA Corporate Data 
Warehouse (CDW) dataset via the VINCI or another secure platform.   
  Retrospective data collection and/or specimens obtained from an IRB-approved 
data and/or specimen repository.  Indicate the repository source including name, VA 
location, and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a Data 
Use Agreement (DUA) must be executed prior to obtaining data and/or specimens.  See 
VHA Handbook 1200.12 for further information. 
3. Level of Data:   

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 28 of 38 
The following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
  Identifiable—Data contains direct identifiers.   
  Coded—Data linked to a specific by a code rather than a direct identifier for re-
identification purposes. Only someone possessing the key to the code can link the data 
to a particular participant.    
  De-Identified (all 18 HIPAA identifiers removed  
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of 18 HIPAA identifiers   
  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data and/or Specimen Location: All survey data will be collected and stored on VA 
secure server for the Study RedCap survey located on VINCI. 
For Aim 3a and Aim 3b, data will be stored electronically in 
R:\TARDIS_Photo_IRB1650875. Data that will be stored electronically include 
electronic versions of recruitment letters, scanned copies of completed surveys, hard 
copy surveys, database with study cohort criteria. Paper records of data include hard 
copy of telephone screening documents, and surveys, etc., will be stored at Legacy 
tower, suite 700, cubical 716B and office 605.  
 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics 
and Computing Infrastructure is a partnership between the VA Office of Information 
Technology and the Veterans’ Health Administration Office of Research and 
Development.  Researchers and operations staff can use VINCI to access data and 
statistical analysis tools in a virtual working environment through a certified VHA 
network computer using the VA Intranet or Virtual Private Network (VPN).  
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National 
Archives and Records Administration, Records Schedule Number:  DAA-0015-2015-
0004.  Records destruction, when authorized, will be accomplished using the then 
current requirements for the secure disposal of paper and electronic records.  Currently, 
destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research 
Investigator Files” for materials included in research records) is scheduled for 6 years 
after the cut-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed 
without pre-notification to the facility records manager. .   

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 29 of 38 
  Other data retention plan, describe:        
5. Data Access and Data Recipients:   
 
Only members of our DVAHCS research team will have access to identifiers and coded 
data.  All VA research personnel who have access to VHA records are instructed, in 
accordance with VA policy, on the requirements of Federal privacy and information laws 
and regulations, VA regulations and policies, and VHA policy. All study personnel who 
are VA employees working within the VA system have fulfilled all required HIPAA and 
other VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of 
Behavior, and all study staff are up-to-date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security 
and privacy procedures summarized in that course include logging off or locking the 
computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and 
disposing of sensitive information using VA-approved methods (e.g., shredder bins). 
Access to study data will be removed for all study personnel when they are no longer 
part of the research team. 
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or 
specimens involved in the study:   
 
I. 
  Data and/or specimens will not be transported or transmitted outside of 
Durham VAMC environment. 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under 
the auspices of the Durham VA Medical Center.   
III. 
   Data and/or specimens will be transmitted to other VA sites using the 
following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted disk (encryption is optional). 
  Data are coded or contain identifiers and thus will be sent  
  Other, describe:        
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional).  

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 30 of 38 
  Specimens are coded or contain identifiers and thus will be sent via VA-
authorized carrier with tracking.   
  Other, describe:        
IV. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., 
academic affiliates, laboratories, etc.) using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via using VA—
approved carrier with tracking.   
  Data are coded or identified and will be sent using Azure RMS encryption 
via a VA email account.  
  Data are coded or identified and will be uploaded to sponsor website 
using electronic case report form (eCRF)  
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional) or will be hand-delivered by research study personnel.  
Specify method of delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with 
tracking or will be hand-delivered by research study personnel.  Specify 
method of delivery:        
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or 
specimens released from the Durham VAMC (with the exception of Limited Data Sets), 
an Accounting of Disclosure (AOD) will be maintained (e.g., in a database or 
spreadsheet) that includes the participant’s name, date of the disclosure, description of 
the nature of the Individually Identifiable Information (III) disclosed, purpose of each 
disclosure, and the name and address of the person/agency to whom the disclosure 
was made. 
C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” has 
been pre-filled out for each study team member who may transport the data 
and/or specimens off-site.  This (these) forms are included with the IRB 
materials.   

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 31 of 38 
D. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable 
legal authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 
7332; the Health Insurance Portability and Accountability Act; and regulations 
implementing those provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. 
Parts 160 and 164. Anyone who discloses information in violation of the above 
provisions may subject to civil and criminal penalties. 
 
V. 
  We will communicate with veterans enrolled as participants in this research 
study through MyHealtheVet.    
 
7. Risk Mitigation Strategies:   
 
Participant’s identifying information (name and last 4 of social security number) will 
be linked to a study code to be used for all data sets. There will be one key of the 
last 4SS#/Name and study code, on the secure computer server. The VA server will 
only be accessible to study personnel with rights to the folder. These data will be 
entered into the database on the secure VA server. Any paper form will be kept in a 
secure, locked file cabinet in a locked research office in the ADAPT HSRD at Legacy 
Tower, suite 700, office 602 or cubical 716B. They will be identified only by a study 
code. All data will be retained in accordance to the Records Control Schedule, the 
Records Management Officer will be contacted for the current policy, prior to any 
destruction. 
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being 
shared outside of Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before 
being shared outside of Durham VAMC. 
  Data or specimens are coded and the code is not related to, or derived from, 
information about the individual and that code is not otherwise capable of being 
translated as to the identify the individual. Only someone possessing the key to code 
can link the data to a particular participant.    
  Other, specify:        
8. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data 
or non-compliance with security controls occur it will be immediately reported according 
to VA policy. All incidents regarding information security/privacy incidents will be 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 32 of 38 
reported to the ISO and PO within 1 hour of acknowledgement of issue and done so 
using the VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
9. Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never 
identify individual subjects.  Data will be presented in aggregate and individual-level 
data will not be published. 
  Other results reporting plan, describe:       
10. Future Use of Data: 
X  Data will be retained for future use.  This is described elsewhere in the protocol and 
is noted in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
11. Use of Mail Merge Technology 
  Mail merge programs will be used to generate letters and/or address labels for 
mailings to potential or already enrolled research subjects.  The study team is aware 
that to reduce risk of mail merge related privacy incidents, use of mail merge programs 
requires a 25% accuracy check to verify that (potential) research subject name and 
mailing address are properly “matched”.  If discrepancies are found, a 100% accuracy 
check is required before letters may be mailed.   
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e. Software that’s not already 
approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has 
been approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA 
systems.) 
 
 I intend to use previously installed software on my VA computer.  
 
 
13. Use of Cloud Computing Services 
 Cloud computing services will NOT be used in this study. 
 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 33 of 38 
 Cloud computing services WILL be used in this study as described below and have 
been approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud 
computing services that have been approved nationally may be used.) 
 
 
References 
Provide references, if applicable.   
1. 
Veterans Health Administration. VA Research on Diabetes. In: Atlanta, GA. : U.S. 
Department of Veterans Affairs, Veterans Health Administration, Office of 
Research and Development; 2016: 
https://www.research.va.gov/pubs/docs/va_factsheets/Diabetes.pdf. Accessed 
1/3/2018. 
2. 
American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. 
Diabetes Care. 2018. 
3. 
Funnell M, Anderson RM. Working toward the next generation of diabetes self-
management education. Am J Prev Med. 2002;22(4 Suppl):3-5. 
4. 
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management 
education for adults with type 2 diabetes: a meta-analysis of the effect on 
glycemic control. Diabetes Care. 2002;25(7):1159-1171. 
5. 
The Diabetes Control and Complications Trial Research Group. The Effect of 
Intensive Treatment of Diabetes on the Development and Progression of Long-
Term Complications in Insulin-Dependent Diabetes Mellitus. N Engl J Med. 
1993;329(14):977-986. 
6. 
Ahola AJ, Groop PH. Barriers to self-management of diabetes. Diabet Med. 
2013;30(4):413-420. 
7. 
Laranjo L, Neves AL, Costa A, Ribeiro RT, Couto L, Sa AB. Facilitators, barriers 
and expectations in the self-management of type 2 diabetes--a qualitative study 
from Portugal. The European journal of general practice. 2015;21(2):103-110. 
8. 
Gariepy G, Smith KJ, Schmitz N. Diabetes distress and neighborhood 
characteristics in people with type 2 diabetes. J Psychosom Res. 
2013;75(2):147-152. 
9. 
Tanenbaum ML, Kane NS, Kenowitz J, Gonzalez JS. Diabetes distress from the 
patient's perspective: Qualitative themes and treatment regimen differences 
among adults with type 2 diabetes. J Diabetes Complications. 2016;30(6):1060-
1068. 
10. 
Fisher L, Hessler D, Glasgow RE, et al. REDEEM: a pragmatic trial to reduce 
diabetes distress. Diabetes Care. 2013;36(9):2551-2558. 
11. 
Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of 
comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 
2001;24(6):1069-1078. 
12. 
Aronson B, Palombi L, Walls M. Rates and consequences of posttraumatic 
distress among American Indian adults with type 2 diabetes. J Behav Med. 
2016;39(4):694-703. 
13. 
Aikens JE, Zivin K, Trivedi R, Piette JD. Diabetes self-management support 
using mHealth and enhanced informal caregiving. J Diabetes Complications. 
2014;28(2):171-176. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 34 of 38 
14. 
Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress 
clinically meaningful?: establishing cut points for the Diabetes Distress Scale. 
Diabetes Care. 2012;35(2):259-264. 
15. 
Adriaanse MC, Pouwer F, Dekker JM, et al. Diabetes-related symptom distress in 
association with glucose metabolism and comorbidity: the Hoorn Study. Diabetes 
Care. 2008;31(12):2268-2270. 
16. 
Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. 
An evaluation of its clinical utility. Diabetes Care. 1997;20(5):760-766. 
17. 
Schmitt A, Reimer A, Kulzer B, Haak T, Ehrmann D, Hermanns N. How to assess 
diabetes distress: comparison of the Problem Areas in Diabetes Scale (PAID) 
and the Diabetes Distress Scale (DDS). Diabet Med. 2016;33(6):835-843. 
18. 
Fisher L, Glasgow RE, Strycker LA. The relationship between diabetes distress 
and clinical depression with glycemic control among patients with type 2 
diabetes. Diabetes Care. 2010;33(5):1034-1036. 
19. 
Baek RN, Tanenbaum ML, Gonzalez JS. Diabetes burden and diabetes distress: 
the buffering effect of social support. Ann Behav Med. 2014;48(2):145-155. 
20. 
Berry E, Lockhart S, Davies M, Lindsay JR, Dempster M. Diabetes distress: 
understanding the hidden struggles of living with diabetes & exploring 
intervention strategies. Postgrad Med J. 2015;91(1075):278-283. 
21. 
Dennick K, Sturt J, Speight J. What is diabetes distress and how can we 
measure it? A narrative review and conceptual model. J Diabetes Complications. 
2017;31(5):898-911. 
22. 
Chesla CA, Chun KM, Kwan CM, et al. Testing the efficacy of culturally adapted 
coping skills training for Chinese American immigrants with type 2 diabetes using 
community-based participatory research. Res Nurs Health. 2013;36(4):359-372. 
23. 
Carolan M, Holman J, Ferrari M. Experiences of diabetes self‐management: A 
focus group study among australians with type 2 diabetes. J Clin Nurs. 
2015;24(7-8):1011-1023. 
24. 
Fisher L, Mullan JT, Skaff MM, Glasgow RE, Arean P, Hessler D. Predicting 
diabetes distress in patients with Type 2 diabetes: a longitudinal study. Diabet 
Med. 2009;26(6):622-627. 
25. 
Faber-Wildeboer AT, van Os-Medendorp H, Kooy A, Sol BGM. Prevalence and 
risk factors of depression and diabetes-related emotional distress in patients with 
type 2 diabetes: A cross-sectional study. Journal of Nursing Education & 
Practice. 2013;3(6):61-69. 
26. 
Lipscombe C, Smith KJ, Gariepy G, Schmitz N. Gender differences in the 
association between lifestyle behaviors and diabetes distress in a community 
sample of adults with type 2 diabetes. Journal of diabetes. 2016;8(2):269-278. 
27. 
Perrin NE, Davies MJ, Robertson N, Snoek FJ, Khunti K. The prevalence of 
diabetes-specific emotional distress in people with Type 2 diabetes: a systematic 
review and meta-analysis. Diabet Med. 2017. 
28. 
Sturt J, Dennick K, Hessler D, Hunter BM, Oliver J, Fisher L. Effective 
interventions for reducing diabetes distress: systematic review and meta-
analysis. International Diabetes Nursing. 2015;12(2):40-55. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 35 of 38 
29. 
Dennick K, Sturt J, Hessler D, et al. High rates of elevated diabetes distress in 
research populations: A systematic review and meta-analysis. International 
Diabetes Nursing. 2015;12(3):93-107. 
30. 
Chew B-H, Vos RC, Pouwer F, Rutten GEHM. The associations between 
diabetes distress and self-efficacy, medication adherence, self-care activities and 
disease control depend on the way diabetes distress is measured: Comparing 
the DDS-17, DDS-2 and the PAID-5. Diabetes Res Clin Pract. 2018;142:74-84. 
31. 
Carper MM, Traeger L, Gonzalez JS, Wexler DJ, Psaros C, Safren SA. The 
differential associations of depression and diabetes distress with quality of life 
domains in type 2 diabetes. J Behav Med. 2014;37(3):501-510. 
32. 
Polonsky WH, Fisher L, Earles J, et al. Assessing psychosocial distress in 
diabetes: development of the diabetes distress scale. Diabetes Care. 
2005;28(3):626-631. 
33. 
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity 
of a two-item depression screener. Med Care. 2003;41(11):1284-1292. 
34. 
Prins A, Bovin MJ, Smolenski DJ, et al. The Primary Care PTSD Screen for 
DSM-5 (PC-PTSD-5): Development & Eval. Within a Veteran Primary Care 
Sample. J Gen Intern Med. 2016;31(10):1206-1211. 
35. 
Billioux A, Verlander K, Anthony S, Alley D. Standardized Screening for Health-
Related Social Needs in Clinical Settings. 2017. 
36. 
Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The diabetes 
empowerment scale-short form (DES-SF). Diabetes Care. 2003;26(5):1641-
1642. 
37. 
Kerfoot BP, Gagnon DR, McMahon GT, Orlander JD, Kurgansky KE, Conlin PR. 
A Team-Based Online Game Improves Blood Glucose Control in Veterans With 
Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 
2017;40(9):1218-1225. 
38. 
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care 
activities measure: results from 7 studies and a revised scale. Diabetes Care. 
2000;23(7):943-950. 
39. 
Weinger K, Butler HA, Welch GW, et al. Measuring diabetes self-care: a 
psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes 
Care. 2005;28(6):1346-1352. 
40. 
Molina Y, Choi SW, Cella D, Rao D. The stigma scale for chronic illnesses 8-item 
version (SSCI-8): development, validation and use across neurological 
conditions. Int J Behav Med. 2013;20(3):450-460. 
41. 
Chen CX, Kroenke K, Stump TE, et al. Estimating minimally important 
differences for the PROMIS pain interference scales: results from 3 randomized 
clinical trials. Pain. 2018;159(4):775-782. 
42. 
Matheny AP, Wachs TD, Ludwig JL, Phillips K. Bringing order out of chaos: 
Psychometric characteristics of the confusion, hubbub, and order scale. J Appl 
Dev Psychol. 1995;16(3):429-444. 
43. 
Zullig LL, Shaw RJ, Crowley MJ, et al. Association between perceived life chaos 
and medication adherence in a postmyocardial infarction population. Circ 
Cardiovasc Qual Outcomes. 2013;6(6):619-625. 

Protocol Number: 1650875     Version Date: 08/08/2024          DVAHCS Protocol Template—V. 02/15/19    Page 36 of 38 
44. 
Jazowski SA, Sico IP, Lindquist JH, et al. Transportation as a barrier to colorectal 
cancer care. BMC Health Serv Res. 2021;21(1):332. 
45. 
Drennan J. Cognitive interviewing: verbal data in the design and pretesting of 
questionnaires. J Adv Nurs. 2003;42(1):57-63. 
46. 
Willis GB. Cognitive interviewing: A tool for improving questionnaire design. Sage 
Publications; 2004. 
47. 
Willis GB, Artino AR, Jr. What Do Our Respondents Think We're Asking? Using 
Cognitive Interviewing to Improve Medical Education Surveys. J Grad Med Educ. 
2013;5(3):353-356. 
48. 
Sandelowski M. Qualitative analysis: what it is and how to begin. Res Nurs 
Health. 1995;18(4):371-375. 
49. 
Guest G, MacQueen KM, Namey EE. Applied thematic analysis. Los Angeles : 
Sage Publications, c2012.; 2012. 
50. 
Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J 
Prev Med. 2009;36(5):452-457. 
51. 
Kadel R, Kip K. A SAS macro to compute effect size (Cohen’sd) and its 
confidence interval from raw survey data. Paper presented at: Proceedings of the 
annual SouthEast SAS Users Group conference2012. 
52. 
Musselwhite K, Cuff L, McGregor L, King KM. The telephone interview is an 
effective method of data collection in clinical nursing research: A discussion 
paper. Int J Nurs Stud. 2007;44(6):1064-1070. 
53. 
Drabble L, Trocki KF, Salcedo B, Walker PC, Korcha RA. Conducting qualitative 
interviews by telephone: Lessons learned from a study of alcohol use among 
sexual minority and heterosexual women. Qualitative social work : QSW : 
research and practice. 2016;15(1):118-133. 
54. 
Creswell J, Plano Clark V. Designing & Conducting Mixed Methods Research. 2 
ed. Thousand Oaks, CA: Sage; 2011. 
55. 
Lewinski AA, Anderson RA, Vorderstrasse AA, Fisher EB, Pan W, Johnson CM. 
Type 2 Diabetes Education and Support in a Virtual Environment: A Secondary 
Analysis of Synchronously Exchanged Social Interaction and Support. J Med 
Internet Res. 2018;20(2):e61. 

Protocol Number: 1      Version Date: 09/13/21         DVAHCS Protocol Template—V. 02/15/19    
Page 37 of 38 
Appendix A:  Expedited Review of Research 
 
The categories of research that may be reviewed by the IRB through the expedited 
review procedure include research activities that present no more than minimal risk to 
human subjects AND involve procedures listed in one or more of the specific categories 
listed below. 
 
The expedited review procedure is not to be used when identification of the subjects or 
their responses would reasonably place them at risk of criminal or civil liability; be 
damaging to the subjects’ financial standing, employability, insurability, or reputation; or 
be stigmatizing, unless reasonable and appropriate protections are implemented so that 
risks related to invasion of privacy and breach of confidentiality are no greater than 
minimal.   The IRB must apply the standard requirements for informed consent (or its 
waiver, alteration, or exception) to all studies that undergo expedited review. 
 
EXPEDITE CATEGORIES  
1-Drugs and Devices:  One of the following must be met: 
 (1) The research is on drugs for which an IND application is not required.   
 (2) The research is on medical devices for which an investigational device exemption 
(IDE) application is not required; or the medical device is cleared or approved for 
marketing, and the medical device is being used in accordance with its cleared or 
approved labeling. 
 
2-Blood Samples:  Collected by finger / heel / ear stick or venipuncture: 
 (1) From healthy, nonpregnant adults who weigh at least 110 pounds.  For these 
subjects, the amounts drawn may not exceed 550 milliliters (ml) in an 8-week period, 
and collection may not occur more frequently than two times per week; or 
 (2) From other adults and children, considering the age, weight, and health of the 
subjects, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these subjects, the amount drawn may not 
exceed the lesser of 50 ml or 3 ml per kilogram (kg) in an 8-week period, and collection 
may not occur more frequently than two times per week.   
 
3-Noninvasive Collection of Biological Specimens:  Collected prospectively for 
research purposes by noninvasive means: 
(1) Hair and nail clippings in a non-disfiguring manner.  
(2) Deciduous teeth at time of exfoliation or if routine patient care indicates a need for 
extraction.  
(3) Permanent teeth if routine patient care indicates a need for extraction. 
(4) Excreta and external secretions (including sweat). 
(5) Uncannulated saliva collected either in an unstimulated fashion or stimulated by 
chewing gumbase or wax or by applying a dilute citric solution to the tongue. 
(6) Placenta removed at delivery. 
(7) Amniotic fluid obtained at the time of rupture of the membrane prior to, or during, 
labor. 
(8) Supra- and subgingival dental plaque and calculus, provided the collection 

Protocol Number: 1      Version Date: 09/13/21         DVAHCS Protocol Template—V. 02/15/19    
Page 38 of 38 
EXPEDITE CATEGORIES  
procedure is not more invasive than routine prophylactic scaling of the teeth and the 
process is accomplished in accordance with accepted prophylactic techniques.  
(9) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth 
washings. 
(10) Sputum collected after saline mist nebulization. 
4-Noninvasive Collection of Data:  Data must be collected through noninvasive 
procedures (not involving general anesthesia or sedation) routinely employed in clinical 
practice, excluding procedures involving x-rays or microwaves.   
(1) Physical sensors that are applied either to the surface of the body or at a distance 
and do not involve input of significant amounts of energy into the subject or an invasion 
of the subject's privacy.  
(2) Weighing the subject. 
(3) Testing sensory acuity.  
(4) Magnetic resonance imaging (MRI).  
(5) Electrocardiography, electroencephalography, thermography, detection of naturally 
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, 
Doppler blood flow, and echocardiography. 
(6) Moderate exercise, muscular strength testing, body composition assessment, and 
flexibility testing, where appropriate, given the age, weight, and health of the individual. 
 
5-Collected Material: Research involves: 
(1) Materials (data, documents, records, or specimens) that have been collected for 
any purpose, including previous research; or 
(2) Materials (data, documents, records, or specimens) that will be collected solely for 
nonresearch purposes (such as medical treatment or diagnosis).  
 
6-Collection of Data From Voice, Video, or Photographs:  Research involves 
collection of data from voice, video, or photographs. 
 
7-Group Characteristics, Surveys, Interviews, and Quality Assurance:  Research 
must be on individual or group characteristics or behavior (including, but not limited to:  
research on perception, cognition, motivation, identity, language, communication, 
cultural beliefs or practices, and social behavior), or will employ survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality 
assurance methodologies.  NOTE:  Some research in this category may be exempt 
from the VA regulations for the protection of human subjects (38 CFR 16.101(b)(2) and 
(b)(3)).  This listing refers only to research that is not exempt.