Adults 18 to 80, any sex, with Diabetes Mellitus, Type II or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Diabetes Distress Scale ScorePrimary· Baseline
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
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
1.979
± 0.781
Aim 3b - TARDIS Intervention
1.824
± 0.784
Follow-Up
Group
Value
95% CI
Aim 3b - TARDIS Intervention
1.781
± 0.653
HbA1c ValuePrimary· Baseline
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.
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
8.464
± 2.367
Aim 3b - TARDIS Intervention
9.705
± 1.508
Photo Elicitation (Aim 3a) Semi-Structured InterviewsPrimary· From consent up to 1 month
Number of semi-structured interviews completed by participants (1 interview per time point per participant)
Consented
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
14
Baseline
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
13
Photo elicitation interview #1
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
5
Photo elicitation interview #2
Group
Value
95% CI
Aim 3a - TARDIS Photo Elicitation
3
Health Coaching Calls (Aim 3b - TARDIS Intervention)Secondary· Coaching calls started two weeks post-baseline to occur up to 3 months after consent
Number of Health Coaching Calls Completed (1 call per participant per time point)
Health Coaching Call #1
Group
Value
95% CI
Aim 3b - TARDIS Intervention
20
Health Coaching Call #2
Group
Value
95% CI
Aim 3b - TARDIS Intervention
20
Health Coaching Call #3
Group
Value
95% CI
Aim 3b - TARDIS Intervention
19
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 8 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06972251.