1822-LB: Family Support for Diabetes Action (FAM-ACT) vs. Traditional Diabetes Management Education and Support—Randomized Comparative Effectiveness Trial

Abstract

Introduction: Family support can be crucial to sustaining gains from diabetes self-management education/support (DSMES), especially for low SES Hispanic adults with diabetes (AWD). DSMES lacks structured approaches to engaging support persons (SP). Our objective was to determine the effectiveness of FAM-ACT, a DSMES program focused on AWD-SP dyads vs DSMES with individual AWD, both CHW-delivered and tailored to Hispanic AWD. Methods: Adult patients with T2D and A1C ≥7.5% at an FQHC serving a Hispanic population were enrolled with an adult SP; dyads were randomized to FAM-ACT or DSMES, then invited to 6 sessions over 6 months. Each FAM-ACT session included SP training on supporting AWD diabetes management. AWD A1C was measured at baseline, 6 and 12 months. The primary outcome was 6-month change in A1C, analyzed using linear mixed models. Results: Among 222 AWD-SP dyads enrolled, AWD were mean age 52 years (SD 10), 38% men, 82% preferred Spanish language, 39% had a high school degree or more. SPs were mean age 45 (SD 13), 47% were the AWD’s spouse/partner, 26% adult child, and 27% sibling/friend/other. AWD completed mean 3.8/6 sessions, and SP in FAM-ACT arm 2.7/6. In ITT analyses, A1C 6-month decline was greater in DSMES than FAM-ACT (-0.97% vs. -0.42%, p=0.06) but at 12 months, they were similar (DSMES -0.55%, FAM-ACT -0.65%, p=0.77). In Complier Average Causal Effect (CACE) analyses based on AWD and SP with at least average expected session attendance, FAM-ACT 6 month A1C decline was -1.32% vs DSMES -0.89%, p=0.59 and at 12 months FAM-ACT had sustained decline (-1.23% vs -0.47% DSMES, p=0.63). Conclusion: FAM-ACT was less effective at lowering 6-month A1C than traditional DSMES among low SES Hispanic adults, however FAM-ACT A1C continued to improve 6 months after the program ended while traditional DSMES gains regressed. When supporters engaged with patients in FAM-ACT, AWD had clinically significantly larger improvements that were sustained. Disclosure A. Rosland: None. G. Piatt: None. E.C. Kieffer: None. F. Valbuena: None. G. Palmisano: None. S. Perez: None. J. Yabes: Other Relationship; Bayer Inc. M. Heisler: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK116733)