TARDIS - Photo Elicitation and Intervention

NCT06972251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-10-08

Study results available
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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

Interventions

BEHAVIORAL

TARDIS Photo Elicitation

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

BEHAVIORAL

TARDIS Intervention

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Allison Lewinski, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972251 on ClinicalTrials.gov