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

Diabetes Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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. Then, these findings will be used to design and test an intervention that provides T2D self-management information in conjunction with facilitating a connection to supportive services tailored to a Veteran's DD. 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.

Clinical Trial 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. Aim 3a, photo elicitation, the purpose of this research study is to further understand DD by expanding on what we have learned thus far in cognitive and semi-structured interviews with Veterans. The purpose of Aim 3b is to design & pilot test an innovative, tailored T2D self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors. In Aim 3b the investigators will determine the feasibility and acceptability of the intervention for Veterans with T2D.

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). In Aim 3a, the photo elicitation study, we will consent up to 50 Veterans in order to enroll 30 Veterans with HbA1c 8% (type 2 diabetes only) to receive TARDIS in addition to standard VHA care (HT care coordination and telemonitoring). The Veteran would be provided with a camera and instructed to take approximately 20 photos over two weeks. We 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 develop and refine the intervention using findings from Aims 1 & 2 and strategies successfully used by co-mentors. To develop the intervention the investigators will conduct semi-structured interviews with stakeholders (n = ~20: physicians, nurses, administrators) to review components (e.g., learning approaches, relevant VA/community resources) to ensure relevancy. The investigators will modify components and the delivery strategy as needed. Then, will test the intervention with 30 Veterans to evaluate feasibility and acceptability, and utilization of recommended supportive services, using quantitative and qualitative approaches.

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. ;

Related Conditions & MeSH terms

• Diabetes
• Diabetes Distress
• Diabetes Mellitus
• Self-Management
• Veteran

• NCT number: NCT04587336
• Study type: Observational
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Start date: August 24, 2020
• Completion date: August 31, 2024