We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587336
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Diabetes Distress Self-Management Veteran Behavioral: Cognitive Interview Behavioral: Baseline Survey Behavioral: Qualitative Interviews Behavioral: TARDIS Photo Elicitation Behavioral: TARDIS Intervention

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS)
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : March 31, 2024
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587336


Contacts
Layout table for location contacts
Contact: Allison Lewinski, PhD (919) 286-0411 ext 174048 allison.lewinski@va.gov
Contact: Chelsea Whitfield, MPH (919) 286-0411 ext 177658 Chelsea.Whitfield@va.gov

Locations
Layout table for location information
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705-3875
Contact: Felicia A McCant, MSW    919-286-0411 ext 4041    felicia.mccant@va.gov   
Contact: Heidi D Bassani    (919) 286-0411    Heidi.Bassani@va.gov   
Principal Investigator: Allison Lewinski, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Allison Lewinski, PhD Durham VA Medical Center, Durham, NC
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
Goldstein K, Perry KR, Lewinski A, Walsh CW, Shepherd-Banigan M, Bosworth HB, Weidenbacher HJ, Blalock D, Zullig LL. How can equitable video visit access be delivered in primary care? A qualitative study among rural primary care teams and patients. BMJ (Clinical research ed.). 2022 Aug 5; 12:. doi:10.1136/ bmjopen-2022-062261.

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04587336    
Other Study ID Numbers: NRI 18-234
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Diabetes
Cardiovascular Disease
Self-management
Diabetes Distress
Veteran
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases