Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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. The purpose of Aim 3 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 3 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 3 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 Design
Arms and Interventions
| Arm | 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.
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| 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.
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| Aim 3 - 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
|
Outcome Measures
Primary Outcome Measures
- Aim1: Differences in Diabetes Distress Scale score by HbA1c level (HbA1c < 9 and HbA1c 9) and by medication regimen (no insulin, insulin). [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of type 2 diabetes (ICD-10 codes: E11.9, E11.8)
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Documentation of HbA1c drawn within the past 180 days
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Able to speak and read English
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Be able to provide informed consent to participate in the study.
Exclusion Criteria:
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New diagnosis of T2D within the last 60 days
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Hospitalization for mental illness within the past 30 days
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Receiving active chemotherapy and/or radiation treatment
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Diagnosis for Metastatic Cancer
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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.)
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Currently receiving Kidney Dialysis
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Limited hearing or speech difficulties that influence the Veteran's ability to complete the survey
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Dementia, delirium, or other cognition issues that influence the Veteran's ability to provide consent and complete the survey.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Durham VA Medical Center, Durham, NC | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Allison Lewinski, PhD, Durham VA Medical Center, Durham, NC
Study Documents (Full-Text)
None provided.More Information
Publications
- Drake C, Batchelder H, Lian T, Cannady M, Weinberger M, Eisenson H, Esmaili E, Lewinski A, Zullig LL, Haley A, Edelman D, Shea CM. Implementation of social needs screening in primary care: a qualitative study using the health equity implementation framework. BMC Health Serv Res. 2021 Sep 17;21(1):975. doi: 10.1186/s12913-021-06991-3.
- Lewinski AA, Bosworth HB, Goldstein KM, Gierisch JM, Jazowski S, McCant F, White-Clark C, Smith VA, Zullig LL. Improving cardiovascular outcomes by using team-supported, EHR-leveraged, active management: Disseminating a successful quality improvement project. Contemp Clin Trials Commun. 2021 Feb 6;21:100705. doi: 10.1016/j.conctc.2021.100705. eCollection 2021 Mar.
- Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
- Lewinski AA, Rushton S, Van Voorhees E, Boggan JC, Whited JD, Shoup JP, Tabriz AA, Adam S, Fulton J, Gordon AM, Ear B, Williams JW Jr, Goldstein KM, Van Noord MG, Gierisch JM. Implementing remote triage in large health systems: A qualitative evidence synthesis. Res Nurs Health. 2021 Feb;44(1):138-154. doi: 10.1002/nur.22093. Epub 2020 Dec 15.
- Lewinski AA, Shapiro A, Gierisch JM, Goldstein KM, Blalock DV, Luedke MW, Gordon AM, Bosworth HB, Drake C, Lewis JD, Sinha SR, Husain AM, Tran TT, Van Noord MG, Williams JW Jr. Barriers and facilitators to implementation of epilepsy self-management programs: a systematic review using qualitative evidence synthesis methods. Syst Rev. 2020 Apr 25;9(1):92. doi: 10.1186/s13643-020-01322-9.
- Lewinski AA, Vaughn J, Diane A, Barnes A, Crowley MJ, Steinberg D, Stevenson J, Yang Q, Vorderstrasse AA, Hatch D, Jiang M, Shaw RJ. Perceptions of Using Multiple Mobile Health Devices to Support Self-Management Among Adults With Type 2 Diabetes: A Qualitative Descriptive Study. J Nurs Scholarsh. 2021 Sep;53(5):643-652. doi: 10.1111/jnu.12667. Epub 2021 Apr 29.
- Pérez-Aldana CA, Lewinski AA, Johnson CM, Vorderstrasse AA, Myneni S. Exchanges in a Virtual Environment for Diabetes Self-Management Education and Support: Social Network Analysis. JMIR Diabetes. 2021 Jan 25;6(1):e21611. doi: 10.2196/21611.
- Yang Q, Hatch D, Crowley MJ, Lewinski AA, Vaughn J, Steinberg D, Vorderstrasse A, Jiang M, Shaw RJ. Digital Phenotyping Self-Monitoring Behaviors for Individuals With Type 2 Diabetes Mellitus: Observational Study Using Latent Class Growth Analysis. JMIR Mhealth Uhealth. 2020 Jun 11;8(6):e17730. doi: 10.2196/17730.
- NRI 18-234