Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model.

BACKGROUND: Diabetes self-management education and support (DSMES) is an effective approach for improving diabetes self-care behaviors to achieve improved glycemic management and other health outcomes. Engaging family members may improve outcomes, both for the person with diabetes (PWD) and for the family members. However, family models of DSMES have been inconsistently defined and delivered. We operationalize Family-DSMES to be generalizable and replicable, detail our protocol for a comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods implementation evaluation plan. METHODS: We will examine Family-DSMES relative to Standard-DSMES using a Hybrid Type 1 effectiveness-implementation design. Participants are ≥18 years old with type 2 diabetes mellitus and hemoglobin A1c ≥7.0%, recruited from rural and urban primary care clinics that are part of an academic medical center. Each participant invites a family member. Dyads are randomly assigned to Family- or Standard-DSMES, delivered in a small-group format via telehealth. Data are collected at baseline, immediately post-intervention, and 6-, 12-, and 18-months post-intervention. Outcomes include PWDs' hemoglobin A1c (primary), other biometric, behavioral, and psychosocial outcomes (secondary), and family members' diabetes-related distress, involvement in the PWD's diabetes management, self-efficacy for providing support, and biometric outcomes (exploratory). Our mixed-methods implementation evaluation will include process data collected during the trial and stakeholder interviews guided by the Consolidated Framework for Implementation Research. CONCLUSION: Results will fill knowledge gaps about which type of DSMES may be most effective and guide Family-DSMES implementation efforts. REGISTRATION: The trial is pre-registered at clinicaltrials.gov (#NCT04334109).