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

NCT04587336 | Completed Results

• 1 other identifier: NRI 18-234
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Distress; Self-Management; Veteran

Keywords

Diabetes; Cardiovascular Disease; Self-management; Diabetes Distress; Veteran

Outcome Measures

Primary Outcomes (2)

• Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9)

  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.

  Baseline

• Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin).

  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.

  Baseline

Study Arms (2)

Aim 0 - Cognitive Interview

Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.

Behavioral: Cognitive Interview

Aim 1 - Baseline Survey

Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.

Behavioral: Baseline Survey; Behavioral: Qualitative Interviews

Interventions

Cognitive Interview BEHAVIORAL

Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.

Aim 0 - Cognitive Interview

Baseline Survey BEHAVIORAL

Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.

Aim 1 - Baseline Survey

Qualitative Interviews BEHAVIORAL

Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.

Aim 1 - Baseline Survey

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (21)

• 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.

  PMID: 32334641 BACKGROUND

• 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.

  PMID: 32525492 BACKGROUND

• 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.

  PMID: 33319411 BACKGROUND

• 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.

  PMID: 33976073 BACKGROUND

• 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.

  PMID: 34530826 BACKGROUND

• 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.

  PMID: 33644491 BACKGROUND

• 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.

  PMID: 33928755 BACKGROUND

• 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.

  PMID: 33492236 BACKGROUND

• 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.

  PMID: 35403322 BACKGROUND

• 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.

  PMID: 34981354 BACKGROUND

• 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.

  PMID: 35961805 BACKGROUND

• 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.

  PMID: 36002348 BACKGROUND

• 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.

  PMID: 36018711 BACKGROUND

• 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.

  PMID: 36661336 BACKGROUND

• 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.

  PMID: 36926446 BACKGROUND

• 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.

  PMID: 34559032 RESULT

• 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.

  PMID: 36650326 RESULT

• 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.

  PMID: 36525906 RESULT

• 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.

  PMID: 36222790 RESULT

• 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.

  PMID: 39216685 RESULT

• Lewinski AA, Shapiro A, Crowley MJ, Whitfield C, Jones JR, Jeffreys AS, Coffman CJ, Howard T, McConnell E, Tanabe P, Barcinas S, Bosworth HB. Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study. J Health Psychol. 2024 Dec;29(14):1593-1607. doi: 10.1177/13591053241233387. Epub 2024 Feb 21.

  PMID: 38384142 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Allison Lewinski, PhD, MPH, RN, FAAN
• Organization: Health Systems Research Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)

Allison.Lewinski@va.gov

919-286-0411

Study Officials

• Allison Lewinski, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: August 24, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)