TARDIS - Photo Elicitation and Intervention

NCT06972251 | Completed Results

• 1 other identifier: NRI 18-234-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type II; Type 2 Diabetes; Diabetes Distress; Self Management; Veteran

Keywords

Diabetes; Type 2 Diabetes; Diabetes distress; Veteran

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• 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.

  Baseline

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

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

  From consent up to 1 month

Secondary Outcomes (1)

• Health Coaching Calls (Aim 3b - TARDIS Intervention)

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

Study Arms (2)

Aim 3a - TARDIS Photo Elicitation

OTHER

To 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.

Behavioral: TARDIS Photo Elicitation

Aim 3b - TARDIS Intervention

OTHER

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.

Behavioral: TARDIS Intervention

Interventions

TARDIS Photo Elicitation BEHAVIORAL

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

Aim 3a - TARDIS Photo Elicitation

TARDIS Intervention BEHAVIORAL

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.

Aim 3b - TARDIS Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (56)

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  BACKGROUND

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• Lewinski AA, Shapiro A, Crowley MJ, Whitfield C, Jones JR, Jeffreys AS, Coffman CJ, Howard T, McConnell E, Tanabe P, Barcinas S, Bosworth HB. Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study. J Health Psychol. 2024 Dec;29(14):1593-1607. doi: 10.1177/13591053241233387. Epub 2024 Feb 21.

  PMID: 38384142 RESULT

• Lewinski AA, Shapiro A, Bosworth HB, Crowley MJ, McCant F, Howard T, Jeffreys AS, McConnell E, Tanabe P, Barcinas S, Coffman CJ, King HA. Veterans' Interpretation of Diabetes Distress in Diabetes Self-Management: Findings From Cognitive Interviews. Sci Diabetes Self Manag Care. 2021 Oct;47(5):391-403. doi: 10.1177/26350106211043487. Epub 2021 Sep 24.

  PMID: 34559032 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Allison Lewinski, PhD, MPH, RN, FAAN
• Organization: Health Systems Research Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)

allison.lewinski@va.gov

919-286-0411

Study Officials

• Allison Lewinski, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: March 8, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)