NCT06972251Completed
TARDIS - Photo Elicitation and Intervention
Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 6 May 2025
- Start date
- 8 Mar 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Type 2 diabetes
- NCT number
- NCT06972251
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 8 Mar 2022 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving active chemotherapy and/or radiation treatment
- Currently receiving kidney dialysis
Other illness
- Hospitalization for mental illness within the past 30 days
- 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.)
- Dementia, delirium, or other cognition issues that influence the Veteran's ability to provide consent and complete the survey
Other
- New diagnosis of T2D within the last 60 days
- Limited hearing or speech difficulties that influence the Veteran's ability to complete the survey and intervention
- Not currently prescribed insulin (Aim 3b only)
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Durham VA Medical Center, Durham, NC Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.