Clinical trial NCT04587336: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes
Official title: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Survey & Qualitative Interview
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Distress
Self-Management
Veteran
Keywords: Diabetes
Cardiovascular Disease
Self-management
Diabetes Distress
Veteran
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-10-14
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Veterans with diagnosis of type 2 diabetes for longer than 60 days with documented HbA1c drawn within 180 days prior to enrollment and able to speak and read English

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. 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.

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.

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).

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.

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

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

Primary outcomes:
measure: Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9)
timeFrame: Baseline
measure: Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin).
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:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Perez-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.
citation: Rushton S, Lewinski AA, Hwang S, Zullig LL, Ball Ricks KA, Ramos K, Gordon A, Ear B, Ballengee LA, Brahmajothi MV, Moore T, Blalock DV, Williams JW Jr, Cantrell SE, Gierisch JM, Goldstein KM. Barriers and facilitators to the implementation and adoption of improvement coaching: A qualitative evidence synthesis. J Clin Nurs. 2023 Jan;32(1-2):3-30. doi: 10.1111/jocn.16247. Epub 2022 Apr 10.
citation: Ballengee LA, Rushton S, Lewinski AA, Hwang S, Zullig LL, Ricks KAB, Ramos K, Brahmajothi MV, Moore TS, Blalock DV, Cantrell S, Kosinski AS, Gordon A, Ear B, Williams JW Jr, Gierisch JM, Goldstein KM. Effectiveness of Quality Improvement Coaching on Process Outcomes in Health Care Settings: A Systematic Review. J Gen Intern Med. 2022 Mar;37(4):885-899. doi: 10.1007/s11606-021-07217-2. Epub 2022 Jan 3.
citation: Byrd JT, Daniels CL, Flores DD, Kayle M, Lewinski AA, Smith JB, Xu H, Tanabe PJ. Establishing a research racial justice task force to improve diversity, equity, and inclusion in nursing research. Nurs Outlook. 2022 Sep-Oct;70(5):758-761. doi: 10.1016/j.outlook.2022.06.004. Epub 2022 Aug 10. No abstract available.
citation: Lewinski AA, Jazowski SA, Goldstein KM, Whitney C, Bosworth HB, Zullig LL. Intensifying approaches to address clinical inertia among cardiovascular disease risk factors: A narrative review. Patient Educ Couns. 2022 Dec;105(12):3381-3388. doi: 10.1016/j.pec.2022.08.005. Epub 2022 Aug 18.
citation: Lewinski AA, Walsh C, Rushton S, Soliman D, Carlson SM, Luedke MW, Halpern DJ, Crowley MJ, Shaw RJ, Sharpe JA, Alexopoulos AS, Tabriz AA, Dietch JR, Uthappa DM, Hwang S, Ball Ricks KA, Cantrell S, Kosinski AS, Ear B, Gordon AM, Gierisch JM, Williams JW Jr, Goldstein KM. Telehealth for the Longitudinal Management of Chronic Conditions: Systematic Review. J Med Internet Res. 2022 Aug 26;24(8):e37100. doi: 10.2196/37100.
citation: Zullig LL, Lewinski AA, Woolson SL, White-Clark C, Miller C, Bosworth HB, Burleson SC, Garrett MP, Darling KL, Crowley MJ. Research-practice partnerships: Adapting a care coordination intervention for rural Veterans over 3 years at multiple sites. J Rural Health. 2023 Jun;39(3):575-581. doi: 10.1111/jrh.12740. Epub 2023 Jan 20.
citation: German J, Kobe EA, Lewinski AA, Jeffreys AS, Coffman C, Edelman D, Batch BC, Crowley MJ. Factors Associated With Diabetes Distress Among Patients With Poorly Controlled Type 2 Diabetes. J Endocr Soc. 2023 Feb 28;7(5):bvad031. doi: 10.1210/jendso/bvad031. eCollection 2023 Mar 6.
citation: Lewinski AA, Shapiro A, Bosworth HB, Crowley MJ, McCant F, Howard T, Jeffreys AS, McConnell E, Tanabe P, Barcinas S, Coffman CJ, King HA. Veterans' Interpretation of Diabetes Distress in Diabetes Self-Management: Findings From Cognitive Interviews. Sci Diabetes Self Manag Care. 2021 Oct;47(5):391-403. doi: 10.1177/26350106211043487. Epub 2021 Sep 24.
citation: Walsh C, Sullivan C, Bosworth HB, Wilson S, Gierisch JM, Goodwin KB, Mccant F, Hoenig H, Heyworth L, Zulman DM, Turvey C, Moy E, Lewinski AA. Incorporating TechQuity in Virtual Care Within the Veterans Health Administration: Identifying Future Research and Operations Priorities. J Gen Intern Med. 2023 Jul;38(9):2130-2138. doi: 10.1007/s11606-023-08029-2. Epub 2023 Jan 17.
citation: Alexopoulos AS, Soliman D, Lewinski AA, Strawbridge E, Steinhauser K, Edelman D, Crowley MJ. Simplifying therapy to assure glycemic control and engagement (STAGE) in poorly-controlled diabetes: A pilot study. J Diabetes Complications. 2023 Jan;37(1):108364. doi: 10.1016/j.jdiacomp.2022.108364. Epub 2022 Dec 5.
citation: Lian T, Reid H, Rader A, Dewitt-Feldman S, Hezarkhani E, Gu E, Scott M, Kutzer K, Sandhu S, Crowder C, Ito K, Eisenson H, Bettger JP, Shaw RJ, Lewinski AA, Ming DY, Bosworth HB, Zullig LL, Batch BC, Drake C. A Tailored SMS Text Message-Based Intervention to Facilitate Patient Access to Referred Community-Based Social Needs Resources: Protocol for a Pilot Feasibility and Acceptability Study. JMIR Res Protoc. 2022 Oct 11;11(10):e37316. doi: 10.2196/37316.
citation: German J, Yang Q, Hatch D, Lewinski A, Bosworth HB, Kaufman BG, Chatterjee R, Pennington G, Matters D, Lee D, Urlichich D, Kokosa S, Canupp H, Gregory P, Roberson CL, Smith B, Huber S, Doukellis K, Deal T, Burns R, Crowley MJ, Shaw RJ. EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial. Contemp Clin Trials. 2024 Nov;146:107673. doi: 10.1016/j.cct.2024.107673. Epub 2024 Aug 30.