Clinical trial NCT06972251: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention
Official title: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II
Type 2 Diabetes
Diabetes Distress
Self Management
Veteran
Keywords: Diabetes
Type 2 Diabetes
Diabetes distress
Veteran
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 ID 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 feasibility and acceptability trial 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 support, and referrals to 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.

Detailed description: Background and Significance: An estimated 20-25% of Veterans are diagnosed with diabetes, an incidence three times higher than the national rate. Treatment and management of poorly self-managed diabetes is costly as medical care costs are 2.3 times higher for individuals with diabetes than for those who do not have the disease. Regular preventative care is essential to prevent comorbidities and maintain optimal health. Individuals with T2D provide 99% of their own care; self-management of T2D is person-specific and ever-present. Consistent and sustained self-management decreases comorbidity development, and positively influences quality of life and psychosocial outcomes. Inconsistent self-management increases the risk of poor health outcomes including microvascular and/or macrovascular problems and psychosocial complications. Yet rates of self-management remain sub-optimal.

T2D self-management is omnipresent, inescapable, and burdensome. A Veteran may become overwhelmed and/or frustrated because of the amount and frequency of T2D self-management behaviors, and these negative feelings may lead to inattention to critical self-management behaviors such as eating healthy or blood glucose checks. Veterans often experience challenges to self-management despite knowing the importance of these behaviors. Self-management challenges include limited access to a healthcare provider, unreliable transportation, limited knowledge of healthy food options, beliefs about T2D medications, or a lack of support. Additionally, diabetes distress (DD) and other psychosocial factors (i.e., depression, post-traumatic stress disorder) negatively influence an individual's engagement in self-management and health outcomes. Due to the inherent complexity of T2D self-management, the investigators propose that tailoring on DD is one way to focus the provision of tailored self-management information and connections to supportive services.

Diabetes distress encompasses the cognitive, physical, and affective experience of living with T2D. Diabetes distress occurs when an individual is overwhelmed with T2D, related self-management behaviors, and knowledge that T2D is progressive and incurable. Diabetes distress is subjective and person-specific; and while DD may fluctuate over time, DD may be continually present. Undiagnosed and untreated DD, may be one cause of a Veteran's poor self-management, thus resulting in poor health outcomes.

Diabetes distress is commonly assessed via the Diabetes Distress Scale or the Problem Areas in Diabetes Scale. Research indicates both measures demonstrate the construct of DD is distinct from general anxiety, stress, and depression. Both the Diabetes Distress Scale and Problem Areas in Diabetes scales assess DD in several domains, and each DD domain addresses a separate aspect of the burden of T2D. The Diabetes Distress Scale measures DD in four domains (i.e., regimen, emotional, interpersonal, healthcare provider), and the Problem Areas in Diabetes Scale assesses DD using similar domains (i.e., emotional, diabetes management, treatment, and social support burden). The Diabetes Distress Scale and Problem Areas in Diabetes Scale have demonstrated content validity in measuring an individual's perception of the resources available, or not available, for self-management. Diabetes distress is associated with more T2D complications, increased stress, being prescribed insulin by a healthcare provider, poor diet and exercise, inadequate support environments, and is more prevalent among women. Diabetes distress levels correlate with self-management behaviors such as monitoring one's diet, engaging with providers, and monitoring one's blood glucose. High to moderate levels of DD are related to poorer glucose regulation, higher HbA1c, lower medication adherence, and poorer quality of life. Individuals with DD report diabetes-related physical burden, health care system distress, and distress with comorbid conditions. In this study, the investigators will further examine the Veteran's experience of DD.

The TARDIS grant and the prior work done for TARDIS was based upon the original Diabetes Distress Scale (DDS) and the four domains within that scale. Those domains include: regimen, provider, interpersonal, and emotional. In 2022, the authors of the Diabetes Distress Scale published an updated version of the DDS called the Type 2 Diabetes Distress Assessment System (T2D-DDAS). The T2D-DDAS contains core and source items that contribute to DD. The T2D-DDAS sources include: hypoglycemia, long-term health, health care provider, interpersonal issues, shame/stigma, healthcare access, and management demands. The sources or facets of DD the investigators identified in the TARDIS foundational work are reflected in the T2D-DDAS. Of note, the investigators identified several additional facets of DD in our work such as pain, military experience, living with comorbidities, and being a caregiver. The scoring for low, moderate, and high DD in the DDS and the T2D-DDAS is the same. For the TARDIS intervention, the investigators will be focusing on the domains of DD as measured by the DDS and not the sources of DD as measured by the T2D-DDAS. The DDS is in the Cerner EHR and is being used in the VA and the foundational TARDIS work uses the DDS.

Aim 3a: Visual Based Qualitative Methods Visual-based qualitative methods will help us identify and more robustly describe DD in Veterans and will expand on what the investigators have learned thus far in cognitive and semi-structured interviews. Veterans will have the autonomy to select photos that impact, either positively or negatively, their DD and diabetes self-management behaviors. Veterans who participate in the project may want to share their experiences because this is their personal story which they want to share to help other people. The Veteran has the autonomy to decide what, and how much, information to share.

Aim 3b: TARDIS Intervention The TARDIS intervention builds upon data collected in Aim 3a. Health coaching is a person-centered approach to identifying health goals, challenges to these goals, and then developing strategies to address these challenges. For the purposes of TARDIS, interactions are 1:1 between a 'coach', or someone who has received training in motivational interviewing, and a Veteran with T2DM. This personalized approach can help elicit, understand, and address the experience of DD, and its impact on T2DM self-management, in Veterans with T2DM. With personalized, Veteran-centric information and support, a Veteran may be more equipped to implement self-management to overcome his/her personal modifiable challenges to engaging in T2DM self-management.

Eligibility criteria: 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
* Own a smartphone or mobile device to take photos (Aim 3a only)
* A1C greater than or equal to 8.5 (Aim 3b only)
* Be prescribed insulin (Aim 3b only)

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 and intervention
* Dementia, delirium, or other cognition issues that influence the Veteran's ability to provide consent and complete the survey
* Not currently prescribed insulin (Aim 3b only)

Primary outcomes:
measure: Diabetes Distress Scale Score
timeFrame: Baseline
measure: HbA1c value
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Allison Lewinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: