Diabetes, Diabetes Distress, Self-Management, Veteran
Conditions
Keywords
Diabetes, Cardiovascular Disease, Self-management, Diabetes Distress, Veteran
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.
Interventions
BEHAVIORALCognitive Interview
Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
BEHAVIORALBaseline Survey
Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
BEHAVIORALQualitative Interviews
Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.
Sponsors
VA Office of Research and Development
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9) | 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). | 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. |
Countries
United States
Participant flow
Recruitment details
To identify potential participants, we completed computer-based screening using the inclusion/exclusion criteria with medical record data. An informational letter was sent to potential participants and provided contact information if they wanted to opt out. Veterans who did not opt out were screened for eligibility using a telephone-based screening questionnaire. Participants were recruited from August 2020 - July 2021 for the surveys and cognitive interviews.
Pre-assignment details
Participants who are listed under started for the time periods below were only enrolled/consented to participate and were not assigned an intervention at that time point. All participants have the option to voluntarily withdraw at any time during the study period. Participants who completed study procedures (baseline cognitive interview or baseline survey) were noted as completed within the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| Aim 0 - Cognitive Interview Cognitive Interviews: Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
Cognitive Interview: Cognitive Interviews: Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D. | 15 |
| 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.
Baseline Survey: Conduct Baseline Survey: Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
Qualitative Interviews: Qualitative Interviews: Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D. | 210 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Aim 0 - Cognitive Interview | Aim 1 - Baseline Survey | Total |
|---|---|---|---|
| Age, Continuous | 60.867 years STANDARD_DEVIATION 8.551 | 63.386 years STANDARD_DEVIATION 10.235 | 63.218 years STANDARD_DEVIATION 10.134 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 202 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 128 Participants | 136 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) White | 6 Participants | 65 Participants | 71 Participants |
| Region of Enrollment United States | 15 Participants | 210 Participants | 225 Participants |
| Sex: Female, Male Female | 4 Participants | 32 Participants | 36 Participants |
| Sex: Female, Male Male | 11 Participants | 178 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 210 |
| other Total, other adverse events | 0 / 15 | 0 / 210 |
| serious Total, serious adverse events | 0 / 15 | 0 / 210 |
Outcome results
Primary
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.
Time frame: Baseline
Population: Veterans are classified into well-controlled (defined by HbA1c value \< 9 during the past 180 days) and poorly-controlled (HbA1c value ≥ 9 during the past 180 days).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HbA1c < 9 | Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9) | 1.907 score on a scale | Standard Deviation 0.882 |
| HbA1c ≥ 9 | Aim 1: Differences in Diabetes Distress Scale Score by HbA1c Level (HbA1c < 9 and HbA1c ≥ 9) | 2.054 score on a scale | Standard Deviation 0.943 |
Primary
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.
Time frame: Baseline
Population: Veterans are classified 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)).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HbA1c < 9 | Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin). | 2.102 score on a scale | Standard Deviation 1.013 |
| HbA1c ≥ 9 | Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin). | 1.824 score on a scale | Standard Deviation 0.749 |