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Diabetes Mellitus, Type IITARDISNCT06972251

TARDIS - Photo Elicitation and Intervention

A study testing TARDIS Photo Elicitation and TARDIS Intervention in people with Diabetes Mellitus, Type II and Type 2 Diabetes, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
TARDIS Photo Elicitation and TARDIS Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
8 Mar 2022to 31 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 mobile phone with advanced computing capabilities (otherwise known as a smartphone) or mobile device to take photos (Aim 3a only)
  • hemoglobin A1C (HbA1C) test value greater than or equal to 8.5 (Aim 3b only)
  • Be prescribed insulin (Aim 3b only)

Who cannot join

  • 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 medication regimen (e.g., myocardial infarction, cerebrovascular accident, coronary artery bypass grafting, etc.)
  • Currently receiving kidney dialysis
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

Other trials in United States

About this study

Official title: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention

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 purpose of this study is to further understand DD by expanding on what the investigators have learned thus far in cognitive and semi-structured interviews with Veterans (see ClinicalTrials.gov identifier NCT04587336). 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. The investigators 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. In Aim 3b, the investigators will conduct a pilot study of a novel telemedicine intervention.

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 referrals to Veterans Health Administration (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.

Read the detailed description

Background and Significance: An estimated 20-25% of Veterans are diagnosed with diabetes, 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. 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. Consistent and sustained self-management decreases comorbidity development, and positively influences quality of life and psychosocial outcomes. Inconsistent self-management increases the risk of poor health outcomes including microvascular and/or macrovascular problems and psychosocial complications. 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. Veterans often experience challenges to self-management despite knowing the importance of these behaviors. 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. Additionally, diabetes distress (DD) and other psychosocial factors (i.e., depression, post-traumatic stress disorder) negatively influence an individual's engagement in self-management and health outcomes. Due to the inherent complexity of T2D self-management, the investigators 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 incurable. Diabetes distress is subjective and person-specific; and while DD may fluctuate over time, DD may be continually present. 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 Scale or the Problem Areas in Diabetes Scale. Research indicates both measures demonstrate the construct of DD is distinct from general anxiety, stress, and depression. 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 T2D. The Diabetes Distress Scale measures DD in four domains (i.e., regimen, emotional, interpersonal, healthcare provider), and the Problem Areas in Diabetes Scale assesses DD using similar domains (i.e., emotional, diabetes management, treatment, and social support burden). 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. 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. Diabetes distress levels correlate with self-management behaviors such as monitoring one's diet, engaging with providers, and monitoring one's blood glucose. High to moderate levels of DD are related to poorer glucose regulation, higher HbA1c, lower medication adherence, and poorer quality of life. Individuals with DD report diabetes-related physical burden, health care system distress, and distress with comorbid conditions. In this study, the investigators 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 the investigators identified in the TARDIS foundational work are reflected in the T2D-DDAS. Of note, the investigators 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, the investigators 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 electronic health record (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 the investigators 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 motivational interviewing, and a Veteran with type 2 diabetes mellitus (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.

Being tested
TARDIS Photo Elicitation, TARDIS Intervention
Keywords
Diabetes, Type 2 Diabetes, Diabetes distress, Veteran
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TARDIS Photo ElicitationBehavioural

    Using visual-based qualitative methods to help identify and more robustly describe DD in Veterans.

  • TARDIS InterventionBehavioural

    Design \& pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with type 2 diabetes (T2D), to promote engagement in self-management behaviors.

Study groups in NCT06972251
Study groupRoleWhat they receive
Aim 3a - TARDIS Photo ElicitationOtherTo further understand Diabetes Distress (DD) by expanding on what we have learned thus far in cognitive and semi-structured interviews with Veterans. Visual-based qualitative methods will help identify and more robustly describe DD in Veterans.
Receives: Behavioral: TARDIS Photo Elicitation
Aim 3b - TARDIS InterventionOtherDesign \& pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with type 2 diabetes (T2D), to promote engagement in self-management behaviors.
Receives: Behavioral: TARDIS Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes Distress Scale Score

    Scale used: 17 item Diabetes Distress Scale. Minimum value 1, Maximum value 6 Scoring is: < 2.0 is little or no distress; 2.0-2.9 is moderate distress; and ≥ 3.0 is high distress.

    Higher scores indicate higher diabetes distress or worse outcome.

    Measured: Baseline

  2. HbA1c Value

    The HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.

    Measured: Baseline

  3. Photo Elicitation (Aim 3a) Semi-Structured Interviews

    Number of semi-structured interviews completed by participants (1 interview per time point per participant)

    Measured: From consent up to 1 month

Secondary outcomes (1)
  1. Health Coaching Calls (Aim 3b - TARDIS Intervention)

    Number of Health Coaching Calls Completed (1 call per participant per time point)

    Measured: Coaching calls started two weeks post-baseline to occur up to 3 months after consent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start8 Mar 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06972251
Sponsor's protocol ID
NRI 18-234-1
Acronym
TARDIS
Status last verified
Sep 2025
First submitted
6 May 2025
Last updated
8 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Veterans Health Administration. VA Research on Diabetes. 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.

  • American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.

    PubMed 29567642
  • Funnell MM, Anderson RM. Working toward the next generation of diabetes self-management education. Am J Prev Med. 2002 May;22(4 Suppl):3-5. doi: 10.1016/s0749-3797(02)00431-2. No abstract available.

    PubMed 11985929
  • 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 Jul;25(7):1159-71. doi: 10.2337/diacare.25.7.1159.

    PubMed 12087014
  • Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. 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 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

    PubMed 8366922
  • Ahola AJ, Groop PH. Barriers to self-management of diabetes. Diabet Med. 2013 Apr;30(4):413-20. doi: 10.1111/dme.12105.

    PubMed 23278342
  • 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. Eur J Gen Pract. 2015 Jun;21(2):103-10. doi: 10.3109/13814788.2014.1000855. Epub 2015 Feb 20.

    PubMed 25698085
  • Gariepy G, Smith KJ, Schmitz N. Diabetes distress and neighborhood characteristics in people with type 2 diabetes. J Psychosom Res. 2013 Aug;75(2):147-52. doi: 10.1016/j.jpsychores.2013.05.009. Epub 2013 Jul 3.

    PubMed 23915771
  • 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 Aug;30(6):1060-8. doi: 10.1016/j.jdiacomp.2016.04.023. Epub 2016 May 4.

    PubMed 27217023
  • Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.

    PubMed 23735726
  • Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. doi: 10.2337/diacare.24.6.1069.

    PubMed 11375373
  • Aronson BD, Palombi LC, Walls ML. Rates and consequences of posttraumatic distress among American Indian adults with type 2 diabetes. J Behav Med. 2016 Aug;39(4):694-703. doi: 10.1007/s10865-016-9733-y. Epub 2016 Mar 21.

    PubMed 27001254
  • Aikens JE, Zivin K, Trivedi R, Piette JD. Diabetes self-management support using mHealth and enhanced informal caregiving. J Diabetes Complications. 2014 Mar-Apr;28(2):171-6. doi: 10.1016/j.jdiacomp.2013.11.008. Epub 2013 Nov 27.

    PubMed 24374137
  • 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 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.

    PubMed 22228744
  • Adriaanse MC, Pouwer F, Dekker JM, Nijpels G, Stehouwer CD, Heine RJ, Snoek FJ. Diabetes-related symptom distress in association with glucose metabolism and comorbidity: the Hoorn Study. Diabetes Care. 2008 Dec;31(12):2268-70. doi: 10.2337/dc08-1074. Epub 2008 Aug 26.

    PubMed 18728236

Questions about this trial

What is this clinical trial studying?

A study testing TARDIS Photo Elicitation and TARDIS Intervention in people with Diabetes Mellitus, Type II and Type 2 Diabetes, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Distress Scale Score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06972251, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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