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NCT06972251 · ClinicalTrials.gov registry record · NA
TARDIS - Photo Elicitation and Intervention
A NA study of Type 2 Diabetes and Diabetes Mellitus Type II, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT06972251: Completed NA study of Type 2 Diabetes and Diabetes Mellitus Type II, sponsored by VA Office of Research and Development.
NCT06972251 is a NA study of Type 2 Diabetes and Diabetes Mellitus Type II that has completed, run by VA Office of Research and Development. The registered enrollment target is 34 participants, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06972251, a NA study of Type 2 Diabetes and Diabetes Mellitus Type II, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL TARDIS Photo Elicitation
- BEHAVIORAL TARDIS Intervention
Study Locations (1)
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
What the finished NCT06972251 record still lists
NCT06972251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which TARDIS Photo Elicitation is the first listed.
NCT06972251 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06972251 about?
NCT06972251 is a clinical study titled "TARDIS - Photo Elicitation and Intervention". 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 influence...
What is the current status of trial NCT06972251?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2022-03-08. Estimated completion is 2025-03-31.
What conditions does trial NCT06972251 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Diabetes Mellitus Type II, Self-management, Diabetes Distress, Veteran.
What interventions are being tested in trial NCT06972251?
The interventions under investigation include: TARDIS Photo Elicitation (BEHAVIORAL), TARDIS Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06972251?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06972251 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06972251's enrollment target sits among peer trials
34 250th of 327 higher than 76 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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