TARDIS - Photo Elicitation and Intervention

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT06972251
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TARDIS Photo Elicitation — BEHAVIORAL
    Using visual-based qualitative methods to help identify and more robustly describe DD in Veterans.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 8, 2022
Status verified
Sep 2025
Primary completion
Mar 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Aim 3a - TARDIS Photo Elicitation
    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.
  • Other: Aim 3b - 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.

Primary Outcome Measure

Diabetes Distress Scale Score [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875-

Find similar trials in Durham, NC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Durham VA Medical Center, Durham, NC· Durham, NC

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