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TARDIS - Photo Elicitation and Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06972251
Acronym
TARDIS
Enrollment
34
Registered
2025-05-14
Start date
2022-03-08
Completion date
2025-03-31
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Distress, Diabetes Mellitus, Type II, Self Management, Type 2 Diabetes, Veteran

Keywords

Diabetes, Type 2 Diabetes, Diabetes distress, Veteran

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 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.

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 electronic health record (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 type 2 diabetes mellitus (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.

Interventions

BEHAVIORALTARDIS Photo Elicitation

Using visual-based qualitative methods to help identify and more robustly describe DD in Veterans.

BEHAVIORALTARDIS Intervention

Design & pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with type 2 diabetes (T2D), to promote engagement in self-management behaviors.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 mobile phone with advanced computing capabilities (otherwise known as a smartphone) or mobile device to take photos (Aim 3a only) * hemoglobin A1C (HbA1C) test value 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)

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Distress Scale ScoreBaselineScale 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.
HbA1c ValueBaselineThe HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.
Photo Elicitation (Aim 3a) Semi-Structured InterviewsFrom consent up to 1 monthNumber of semi-structured interviews completed by participants (1 interview per time point per participant)

Secondary

MeasureTime frameDescription
Health Coaching Calls (Aim 3b - TARDIS Intervention)Coaching calls started two weeks post-baseline to occur up to 3 months after consentNumber of Health Coaching Calls Completed (1 call per participant per time point)

Countries

United States

Participant flow

Participants by arm

ArmCount
Aim 3a - TARDIS Photo Elicitation
To further understand Diabetes Distress (DD) by expanding on what we have learned thus far in cognitive and semi-structured interviews with Veterans. Visual-based qualitative methods will help identify and more robustly describe DD in Veterans.
14
Aim 3b - TARDIS Intervention
Design & pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors.
20
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up102
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicAim 3b - TARDIS InterventionTotalAim 3a - TARDIS Photo Elicitation
Age, Continuous64.4 Years
STANDARD_DEVIATION 7.591
62.647 Years
STANDARD_DEVIATION 9.201
60.143 Years
STANDARD_DEVIATION 10.918
Diabetes Distress Scale Score1.824 Total score
STANDARD_DEVIATION 0.784
1.888 Total score
STANDARD_DEVIATION 0.775
1.979 Total score
STANDARD_DEVIATION 0.781
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants31 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
16 Participants23 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants8 Participants4 Participants
Region of Enrollment
United States
20 Participants34 Participants14 Participants
Sex: Female, Male
Female
3 Participants8 Participants5 Participants
Sex: Female, Male
Male
17 Participants26 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 20
other
Total, other adverse events
0 / 140 / 20
serious
Total, serious adverse events
0 / 140 / 20

Outcome results

Primary

Diabetes Distress Scale Score

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.

Time frame: Baseline

Population: For Aim 3a, participants did not complete a follow-up survey to assess their Diabetes Distress Scale score as this was not a part of the study design. Only participants in Aim3b (intervention) completed a baseline and follow-up survey to assess their DDS score.

ArmMeasureGroupValue (MEAN)Dispersion
Aim 3a - TARDIS Photo ElicitationDiabetes Distress Scale ScoreBaseline1.979 score on a scaleStandard Deviation 0.781
Aim 3b - TARDIS InterventionDiabetes Distress Scale ScoreBaseline1.824 score on a scaleStandard Deviation 0.784
Aim 3b - TARDIS InterventionDiabetes Distress Scale ScoreFollow-Up1.781 score on a scaleStandard Deviation 0.653
Primary

HbA1c Value

The HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Aim 3a - TARDIS Photo ElicitationHbA1c Value8.464 percentage of glycosylated hemoglobinStandard Deviation 2.367
Aim 3b - TARDIS InterventionHbA1c Value9.705 percentage of glycosylated hemoglobinStandard Deviation 1.508
Primary

Photo Elicitation (Aim 3a) Semi-Structured Interviews

Number of semi-structured interviews completed by participants (1 interview per time point per participant)

Time frame: From consent up to 1 month

Population: All participants who consent to Aim 3a will participate in this aim only. There is no randomization process or groups for this aim.

ArmMeasureGroupValue (NUMBER)
Aim 3a - TARDIS Photo ElicitationPhoto Elicitation (Aim 3a) Semi-Structured InterviewsConsented14 count of calls completed
Aim 3a - TARDIS Photo ElicitationPhoto Elicitation (Aim 3a) Semi-Structured InterviewsBaseline13 count of calls completed
Aim 3a - TARDIS Photo ElicitationPhoto Elicitation (Aim 3a) Semi-Structured InterviewsPhoto elicitation interview #15 count of calls completed
Aim 3a - TARDIS Photo ElicitationPhoto Elicitation (Aim 3a) Semi-Structured InterviewsPhoto elicitation interview #23 count of calls completed
Secondary

Health Coaching Calls (Aim 3b - TARDIS Intervention)

Number of Health Coaching Calls Completed (1 call per participant per time point)

Time frame: Coaching calls started two weeks post-baseline to occur up to 3 months after consent

Population: All participants who consent to Aim 3b will participate in this aim only. There is no randomization process or groups for this aim.

ArmMeasureGroupValue (NUMBER)
Aim 3a - TARDIS Photo ElicitationHealth Coaching Calls (Aim 3b - TARDIS Intervention)Health Coaching Call #120 Count of Calls Completed
Aim 3a - TARDIS Photo ElicitationHealth Coaching Calls (Aim 3b - TARDIS Intervention)Health Coaching Call #220 Count of Calls Completed
Aim 3a - TARDIS Photo ElicitationHealth Coaching Calls (Aim 3b - TARDIS Intervention)Health Coaching Call #319 Count of Calls Completed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026