Trial Outcomes & Findings for Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (NCT NCT04587336)

Last Updated: 2025-05-02

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

225 participants

Primary outcome timeframe

Baseline

Results posted on

2025-05-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	210	15
Overall Study COMPLETED	210	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 0 - Cognitive Interview n=15 Participants 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.	Aim 1 - Baseline Survey n=210 Participants 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.	Total n=225 Participants Total of all reporting groups
Age, Continuous	60.867 years STANDARD_DEVIATION 8.551 • n=5 Participants	63.386 years STANDARD_DEVIATION 10.235 • n=7 Participants	63.218 years STANDARD_DEVIATION 10.134 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	32 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	178 Participants n=7 Participants	189 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	202 Participants n=7 Participants	217 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	128 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	65 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	210 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	HbA1c < 9 n=109 Participants HbA1c \< 9 represents well-controlled type 2 diabetes (defined by HbA1c value \< 9 during the past 180 days).	HbA1c ≥ 9 n=101 Participants HbA1c ≥ 9 represents poorly-controlled type 2 diabetes (defined by HbA1c value ≥ 9 during the past 180 days).
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	2.054 score on a scale Standard Deviation 0.943

PRIMARY outcome

Timeframe: 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)).

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.

Outcome measures

Outcome measures
Measure	HbA1c < 9 n=117 Participants HbA1c \< 9 represents well-controlled type 2 diabetes (defined by HbA1c value \< 9 during the past 180 days).	HbA1c ≥ 9 n=93 Participants HbA1c ≥ 9 represents poorly-controlled type 2 diabetes (defined by HbA1c value ≥ 9 during the past 180 days).
Aim 1: Differences in Diabetes Distress Scale Score by Medication Regimen (no Insulin, Insulin).	2.102 score on a scale Standard Deviation 1.013	1.824 score on a scale Standard Deviation 0.749

Adverse Events

Aim 0 - Cognitive Interview

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aim 1 - Baseline Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Lewinski, PhD, MPH, RN, FAAN

Health Systems Research Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place