CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Cognitive Interview +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04587336
NCT04587336N/ACompleted

Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Survey & Qualitative Interview

VA Office of Research and Development·observational·Posted Oct 14, 2020·Updated May 2, 2025

In Brief

An observational study evaluating Cognitive Interview, Baseline Survey, and 1 other intervention for Diabetes and 3 related conditions. Completed, enrolled 225 participants across 1 site.

Detailed Summary

Veterans with diabetes 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. DD negatively influences the Veteran's engagement in self-management and subsequent HbA1c levels. Previous interventions do not tailor T2D self-management information to a Veteran's DD, which may be one reason interventions are ineffective at reducing DD. This proposal examines the impact of correlating factors (e.g., sociodemographic, psychosocial, and environmental) on DD using surveys and semi-structured interviews. This proposal will prepare Allison Lewinski, PhD, MPH, RN for a career as a scientist at VHA focused on developing methods to improve health outcomes among Veterans.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartAug 24, 2020
Primary CompletionMar 31, 2024
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.7 years ago

Interventions

Cognitive Interviewbehavioral

Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.

Baseline Surveybehavioral

Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.

Qualitative Interviewsbehavioral

Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.