Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial

BACKGROUND: Diabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic goals, and reduce risk for complications. One largely untapped resource for this support is AWDs’ social networks. Fifty to 75% of AWDs have an unpaid family member or friend (“support person”) who provides ongoing help with diabetes management. However, DSMES interventions to date lack structured and effective approaches to directly engage support persons in AWDs’ diabetes management. METHODS: This parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community health worker (CHW)-delivered program focused on educating and supporting patients with type 2 diabetes (T2D) and their support persons (SPs), relative to an established, CHW-delivered, individual patient-focused DSMES and care management (I-DSMES) intervention. Both interventions were developed using a community-based participatory research (CBPR) approach. The study will be conducted in partnership with an urban Federally Qualified Health Center (FQHC) serving a low-income, Latino/a community, with target enrollment of 268 dyads consisting of an FQHC patient with T2D with high HbA1c and an SP. Patient-SP dyads will be randomized to receive FAM-ACT or I-DSMES over 6 months. The primary outcome is change in patient HbA1c from baseline to 6 months. Secondary patient outcomes include 12-month change in HbA1c, changes in patient blood pressure, diabetes self-management behaviors, diabetes distress, patient activation, diabetes self-efficacy, and perceptions of and satisfaction with SP support for diabetes. Secondary SP outcomes include self-efficacy for helping the patient with diabetes management and SP distress about the patient’s diabetes. We also will assess the effect of the COVID-19 pandemic on patient’s ability to manage diabetes. DISCUSSION: This study will inform scalable, evidence-based approaches that leverage family support to help AWDs improve and sustain self-management strategies that underpin optimal management of multiple diabetes complication risk factors. The protocol is designed for and evaluated with a low-income and predominantly Latino/a community, which may increase applicability to other similar communities. The COVID-19 pandemic presented several challenges to study protocol and intervention delivery; modifications made to address these challenges are described. TRIAL REGISTRATION: ClinicalTrials.gov NCT03812614. Registered on 18 January 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06764-1.