Trial Outcomes & Findings for TARDIS - Photo Elicitation and Intervention (NCT NCT06972251)

Last Updated: 2025-10-08

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

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Baseline

Results posted on

2025-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Aim 3a - TARDIS Photo Elicitation To further understand Diabetes Distress (DD) 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.	Aim 3b - 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.
Overall Study STARTED	14	20
Overall Study Completed Baseline	13	20
Overall Study COMPLETED	3	18
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Aim 3a - TARDIS Photo Elicitation To further understand Diabetes Distress (DD) 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.	Aim 3b - 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.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	10	2

Baseline Characteristics

TARDIS - Photo Elicitation and Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 3a - TARDIS Photo Elicitation n=14 Participants To further understand Diabetes Distress (DD) 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.	Aim 3b - TARDIS Intervention n=20 Participants Design \& pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors.	Total n=34 Participants Total of all reporting groups
Age, Continuous	60.143 Years STANDARD_DEVIATION 10.918 • n=5 Participants	64.4 Years STANDARD_DEVIATION 7.591 • n=7 Participants	62.647 Years STANDARD_DEVIATION 9.201 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	19 Participants n=7 Participants	31 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
Region of Enrollment United States	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Diabetes Distress Scale Score	1.979 Total score STANDARD_DEVIATION 0.781 • n=5 Participants	1.824 Total score STANDARD_DEVIATION 0.784 • n=7 Participants	1.888 Total score STANDARD_DEVIATION 0.775 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: For Aim 3a, participants did not complete a follow-up survey to assess their Diabetes Distress Scale score as this was not a part of the study design. Only participants in Aim3b (intervention) completed a baseline and follow-up survey to assess their DDS score.

Outcome measures

Outcome measures
Measure	Aim 3a - TARDIS Photo Elicitation n=14 Participants To further understand Diabetes Distress (DD) 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.	Aim 3b - TARDIS Intervention n=20 Participants Design \& pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors.
Diabetes Distress Scale Score Baseline	1.979 score on a scale Standard Deviation 0.781	1.824 score on a scale Standard Deviation 0.784
Diabetes Distress Scale Score Follow-Up	—	1.781 score on a scale Standard Deviation 0.653

PRIMARY outcome

Timeframe: Baseline

The HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.

Outcome measures

Outcome measures
Measure	Aim 3a - TARDIS Photo Elicitation n=14 Participants To further understand Diabetes Distress (DD) 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.	Aim 3b - TARDIS Intervention n=20 Participants Design \& pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors.
HbA1c Value	8.464 percentage of glycosylated hemoglobin Standard Deviation 2.367	9.705 percentage of glycosylated hemoglobin Standard Deviation 1.508

PRIMARY outcome

Timeframe: From consent up to 1 month

Population: All participants who consent to Aim 3a will participate in this aim only. There is no randomization process or groups for this aim.

Number of semi-structured interviews completed by participants (1 interview per time point per participant)

Outcome measures

Outcome measures
Measure	Aim 3a - TARDIS Photo Elicitation n=14 Participants To further understand Diabetes Distress (DD) 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.	Aim 3b - 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.
Photo Elicitation (Aim 3a) Semi-Structured Interviews Consented	14 count of calls completed	—
Photo Elicitation (Aim 3a) Semi-Structured Interviews Baseline	13 count of calls completed	—
Photo Elicitation (Aim 3a) Semi-Structured Interviews Photo elicitation interview #1	5 count of calls completed	—
Photo Elicitation (Aim 3a) Semi-Structured Interviews Photo elicitation interview #2	3 count of calls completed	—

SECONDARY outcome

Timeframe: Coaching calls started two weeks post-baseline to occur up to 3 months after consent

Population: All participants who consent to Aim 3b will participate in this aim only. There is no randomization process or groups for this aim.

Number of Health Coaching Calls Completed (1 call per participant per time point)

Outcome measures

Outcome measures
Measure	Aim 3a - TARDIS Photo Elicitation n=20 Participants To further understand Diabetes Distress (DD) 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.	Aim 3b - 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.
Health Coaching Calls (Aim 3b - TARDIS Intervention) Health Coaching Call #1	20 Count of Calls Completed	—
Health Coaching Calls (Aim 3b - TARDIS Intervention) Health Coaching Call #2	20 Count of Calls Completed	—
Health Coaching Calls (Aim 3b - TARDIS Intervention) Health Coaching Call #3	19 Count of Calls Completed	—

Adverse Events

Aim 3a - TARDIS Photo Elicitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aim 3b - TARDIS Intervention

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