DiabetesTARDISNCT04587336
Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes
An observational study of Diabetes and Diabetes Distress, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Diabetes Distress, Self-Management
- What is being tested?
- Cognitive Interview, Baseline Survey and Qualitative Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Survey & Qualitative Interview
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.
Read the 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.
- Conditions
- Diabetes, Diabetes Distress, Self-Management, Veteran
- Being tested
- Cognitive Interview, Baseline Survey, Qualitative Interviews
- Keywords
- Diabetes, Cardiovascular Disease, Self-management, Diabetes Distress, Veteran
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive InterviewBehavioural
Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
Baseline SurveyBehavioural
Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
Qualitative InterviewsBehavioural
Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.
| Study group | Role | What they receive |
|---|---|---|
| Aim 0 - Cognitive Interview | Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D. Receives: 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. Receives: Behavioral: Baseline Survey; Behavioral: Qualitative Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start24 Aug 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Allison Lewinski, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587336
- Sponsor's protocol ID
- NRI 18-234
- Acronym
- TARDIS
- Status last verified
- Apr 2025
- First submitted
- 7 Oct 2020
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32334641Yang 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.
PubMed 32525492Lewinski 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.
PubMed 33319411Lewinski 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.
PubMed 33976073Drake 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.
PubMed 34530826Lewinski 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.
PubMed 33644491Lewinski 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.
PubMed 33928755Perez-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.
PubMed 33492236Rushton 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.
PubMed 35403322Ballengee 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.
PubMed 34981354Byrd 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.
PubMed 35961805Lewinski 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.
PubMed 36002348Lewinski 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.
PubMed 36018711Zullig 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.
PubMed 36661336German 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.
PubMed 36926446
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Survey & Qualitative Interview
- ClinicalTrials.gov ID
- NCT04587336
- Acronym / sponsor ID
- TARDIS / NRI 18-234
- Conditions
- Diabetes, Diabetes Distress, Self-Management, Veteran
- Keywords
- Diabetes, Cardiovascular Disease, Self-management, Diabetes Distress, Veteran
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 0 - Cognitive Interview | – | Behavioral: Cognitive InterviewExamine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D. |
| Aim 1 - Baseline Survey | – | Behavioral: Baseline Survey, Behavioral: Qualitative InterviewsExamine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive InterviewExamine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D. | Behavioural | Aim 0 - Cognitive Interview |
| Baseline SurveyExamine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD. | Behavioural | Aim 1 - Baseline Survey |
| Qualitative InterviewsDescribe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D. | Behavioural | Aim 1 - Baseline Survey |
Primary outcome
Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9)
Time frame: Baseline
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.
Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin).
Time frame: Baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32334641Lewinski 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.
- Background: PubMed 32525492Yang 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.
- Background: PubMed 33319411Lewinski 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.
- Background: PubMed 33976073Lewinski 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.
- Background: PubMed 34530826Drake 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.
- Background: PubMed 33644491Lewinski 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.
- Background: PubMed 33928755Lewinski 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.
- Background: PubMed 33492236Perez-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.
- Background: PubMed 35403322Rushton 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.
- Background: PubMed 34981354Ballengee 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.
- Background: PubMed 35961805Byrd 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.
- Background: PubMed 36002348Lewinski 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Lewinski, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Distress, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587336, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.