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

April 14, 2025 updated by: VA Office of Research and Development

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Diabetes self-management is critical to sustaining optimal health following diagnosis. Diabetes distress (DD) is a crucial factor that influences a Veteran's engagement in diabetes self-management. DD is distinct from depression, and includes four domains (i.e., regimen, emotional, interpersonal, healthcare provider). The presence of DD negatively impacts engagement in self-management and HbA1c. Despite interventions aimed at decreasing DD, these interventions have shown minimal lasting effects. One reason may be because interventions do not tailor information to an individual's DD.

Significance & Impact: This proposal will be the first to examine the impact of correlating factors on DD, and then design and test a self-management intervention tailored upon a Veteran's DD type. This proposal addresses the VHA Strategic Plan Priority areas of utilizing resources more efficiently and improving the timeliness of services, and the HSR&D Research Priorities of Population Health/Whole Health and Primary Care Practice. This proposal's findings can improve both care delivery and health outcomes of Veterans, as the investigator will help facilitate the Veteran's linkage to ubiquitous, existing VHA and community services.

Innovation: This proposal will develop an intervention that targets sub-optimal T2D self-management by providing tailored self-management information in conjunction with connections to supportive services. The investigators will identify how, and to what extent, DD and its factors, influence a Veteran's self-management behaviors.

Specific Aims: Aim 1 will examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD. These Aim 1 data will inform the identification of modifiable factors and selection of the population for a diabetes self-management intervention for Veterans with T2D. Aim 2 will describe self-management challenges and preferred learning strategies to inform the intervention components and delivery approach for Veterans with T2D. Obtaining in-depth perceptions of DD type, self-management strategies and challenges, and learning preferences is essential to tailoring intervention components.

Methodology: This proposal uses an explanatory, sequential mixed-methods design to describe DD in a sample of Veterans who receive care at Durham. In Aim 1 the investigators will survey Veterans (n = 200), and balance enrollment by HbA1C (< 9 or 9) and medication use (insulin, no insulin). In Aim 2 the investigators will conduct semi-structured interviews with a sub-sample (n = ~36) of Veterans surveyed in Aim 1. The investigators will balance enrollment by HbA1C, medication use, and DD level as operationalized by the Diabetes Distress Scale (low, moderate, high).

Implementation & Next Steps: The next steps include dissemination of findings about DD, and its correlates, and the development of an IIR. This IIR will be a Phase III efficacy trial and will be sufficiently powered to test the effects of providing self-management information and connections to supportive services tailored to a Veteran's DD to improve HbA1c.

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Durham, North Carolina, United States, 27705-3875
    - Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Veterans with diagnosis of type 2 diabetes for longer than 60 days with documented HbA1c drawn within 180 days prior to enrollment and able to speak and read English

Description

Inclusion Criteria:

Diagnosis of type 2 diabetes (ICD-10 codes: E11.9, E11.8)
Documentation of HbA1c drawn within the past 180 days
Able to speak and read English
Be able to provide informed consent to participate in the study

Exclusion Criteria:

New diagnosis of T2D within the last 60 days
Hospitalization for mental illness within the past 30 days
Receiving active chemotherapy and/or radiation treatment
Diagnosis for Metastatic Cancer
Recent hospitalization within the past 60 days that would influence their diabetes medication regimen (e.g., myocardial infarction, cerebrovascular accident, coronary artery bypass grafting, etc.)
Currently receiving Kidney Dialysis
Limited hearing or speech difficulties that influence the Veteran's ability to complete the survey
Dementia, delirium, or other cognition issues that influence the Veteran's ability to provide consent and complete the survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aim 0 - Cognitive Interview Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.	Behavioral: Cognitive Interview Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
Aim 1 - Baseline Survey Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.	Behavioral: Baseline Survey Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD. Behavioral: Qualitative Interviews Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9) Time Frame: 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
Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin). Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

Principal Investigator: Allison Lewinski, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NRI 18-234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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