The 165 000 US children with type 1 diabetes (T1D) face a lifetime of self-management decisions to delay or prevent complications while maintaining quality of life (QOL) for themselves and their parents. Although efficacious resources exist to support self-management, most children with diabetes struggle with achieving glycemic control targets. Experts recommend family-centered self-management approaches that attend to each family's self-management challenges. Currently, no system-level method exists to identify and address each family's self-management barriers, resulting in ineffective or wasted resources. The validated Problem Recognition in Illness Self-Management (PRISM) tool could be used as part of an intervention to tailor family-centered self-management resources by helping each family and its clinicians identify and address self-management barriers.
To assess the impact of family-centered tailoring of diabetes self-management resources on glycemic control, parent and child QOL (primary outcomes), and fear of hypoglycemia (secondary outcome).
Conducted in partnership with families, clinicians, clinic administration, and advocacy organizations, our pragmatic trial enrolled children aged 8 to 16 years with T1D and their parent(s) at 2 sites. Participating families were randomized to receive either tailored self-management resources (intervention) or usual care. Our intervention (1) used PRISM to identify families' self-management barriers, (2) tailored self-management resources to the identified barrier, and (3) coordinated group-based delivery of the tailored resources over 9 months to optimize convenience, efficiency, and sustainability. We used validated measures to assess A, parent and child QOL, and fear of hypoglycemia during the 12-month intervention period and for the subsequent year. We used mixed effects models with repeated measures of study outcomes over time to examine the intervention's impact.
Among 363 potentially eligible families, 267 (74%) consented to participate. Ultimately, 108 families were randomized to usual care and 106 to receive the intervention. Among the participating children, 44% were aged 8 to 12 years, and 56% were aged 13 to 16 years. About half of the children were female (49%) and 84% identified as non-Hispanic White. Mean diabetes duration was 5.4 years (SD 3.3) and 14% had an A <7.5%. Attendance at intervention group sessions was high, with 69% of families attending at least 3 of the 4 sessions. Our analyses demonstrated no overall intervention effect on A, QOL for the child or parent, or on fear of hypoglycemia during or after the intervention. However, in prespecified subgroup analyses, intervention group teenagers (aged 13-16 years) at 1 site had a significantly better A trajectory in the year postintervention than teenagers who received usual care (mean A was lower by 0.059% [95% CI, 0.11-0.01] per month). At this same site, parents of intervention group children aged 8 to 12 years had a significantly better QOL trajectory during the intervention than parents of those who received usual care (mean parent QOL was greater by 0.61 points [95% CI, 0.05-1.17 points] per month).
Although the intervention did not significantly affect outcomes as hypothesized, findings suggest best practices for the process of delivering self-management resources and that the intervention might improve outcomes in select settings.
The trial was conducted at 2 clinical sites, which could limit generalizability of findings.
