Trial Outcomes & Findings for Dynamically Tailored Behavioral Interventions in Diabetes (NCT NCT04226027)

Recruitment occurred from 2020-2023. Initially, participants were recruited in person at two FQHCs via waiting-room outreach and staff referrals. Recruitment paused in March 2020 due to COVID-19. By August 2020, the study transitioned to fully virtual procedures, expanding to four additional sites. The team used secure EHR access to identify eligible participants and conducted outreach by phone.

7,616 participants were assessed for eligibility. Of these, 4,552 did not meet inclusion criteria, 775 declined to participate, and 1,989 were excluded for other reasons. The remaining 300 met the inclusion criteria, were consented and randomized into study arms. Participants were randomized on an individual level. No units other than participants were randomized.

Dynamically Tailored Behavioral Interventions in Diabetes

The main outcome is the mean Hemoglobin A1c at 12 months. In the statistical analysis, we examine difference in mean HbA1c between the study arms at baseline, 6 months, and 12 months.

Diabetes Self-Care Inventory (SCA-I) is a 15-item 5-point Likert scale (1-never engage; 5-always engage) for measuring different aspects of diabetes self-care. The final score ranges from 1 (lowest) to 5 (highest) with a higher score indicating better self-care (better outcome). To account for missing values, the final score was normalized to a 1-100 scale with a higher score indicating better self-care. All analysis was conducted with normalized scores.

Diabetes Self-Efficacy Scale (DSES) is a 15-item 10-point Likert scale (1-not at all confident; 10-totally confident) that measures the belief that one can self-manage one's own health, adapted to diabetes. Final scores are averaged, and the total score ranges from 1 (lowest) to 10 (highest) with a lower score indicating poor self-efficacy (worse outcome).

Problem Areas in Diabetes (PAID) is a 20-item 5-point Likert scale (0=not a problem; 4=very serious problem) that measures the emotional aspect of living with diabetes. The final score ranges from 0 (lowest) to 80 (highest), with a higher score indicating greater emotional discomfort (worse outcome).