N/A
Completed N=34
TARDIS - Photo Elicitation and Intervention
Diabetes Mellitus, Type II · Type 2 Diabetes · Diabetes Distress · Self Management
Source: ClinicalTrials.gov NCT06972251 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Diabetes Distress Scale Score — 1.979; 1.824; 1.781 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Distress Scale Score |
1.979; 1.824; 1.781 | — |
| PRIMARY HbA1c Value |
8.464; 9.705 | — |
| PRIMARY Photo Elicitation (Aim 3a) Semi-Structured Interviews |
14; 13; 5; 3 | — |
| SECONDARY Health Coaching Calls (Aim 3b - TARDIS Intervention) |
20; 20; 19 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT06972251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.