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

February 23, 2024 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Active, not recruiting

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. 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.

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

No

Sampling Method

Probability Sample

Study Population

Veterans with diagnosis of type 2 diabetes for longer than 60 days with documented HbA1c drawn within 180days 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aim 0 - Cognitive Interview
Cognitive Interviews: Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
Behavioral: Cognitive Interview
Cognitive Interviews: Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
Aim 1 - Baseline Survey
Conduct Baseline Survey: Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
Behavioral: Baseline Survey
Conduct Baseline Survey: Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
Behavioral: Qualitative Interviews
Qualitative Interviews: Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.
Aim 3a- TARDIS Photo Elicitation
TARDIS Photo Elicitation: To further understand Diabetes Distress 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.
Behavioral: TARDIS Photo Elicitation
TARDIS Photo Elicitation: Using visual-based qualitative methods to help identify and more robustly describe DD in Veterans.
Aim 3b - TARDIS Pilot
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
Behavioral: TARDIS Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim1: Differences in Diabetes Distress Scale score by HbA1c level (HbA1c < 9 and HbA1c 9) and by medication regimen (no insulin, insulin).
Time Frame: Baseline
The investigators will classify the Veterans into well-controlled (defined by HbA1c value < 9 during the past 180 days) and poorly-controlled (HbA1c value 9 during the past 180 days); the investigators will classify Veterans into no insulin (defined by taking only oral T2D medications and/or non-insulin injectable medications during the past 180 days) and insulin (defined by taking any insulin during the past 180 days; these Veterans may/may not also take oral T2D medication(s)). Scale used: 17 item Diabetes Distress Scale. Minimum value 0.01, Maximum values Scoring is: < 2.0 is little or no distress; 2.0-2.9 is moderate distress; and greater or equal to 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 (Estimated)

March 31, 2024

Study Completion (Estimated)

August 31, 2024

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)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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