Objective
This proposal will determine if an innovative behavioral intervention designed to be delivered to emerging adults with type 1 diabetes in the context of routine diabetes is cost-effective and improves diabetes outcomes (e.g., A1C, TIR, diabetes distress) in a pragmatic randomized controlled trial.
Background Rationale
The majority of emerging adults with type 1 diabetes (T1D) do not meet glycemic targets and experience suboptimal psychosocial outcomes. Few evidence-based interventions exist for this group, and fewer still target health care transition (HCT) readiness to support successful transition to independence with chronic disease management. To assist EAs in effectively managing the stressors and challenges of T1D in the context of their everyday lives, we need interventions that are innovative, developmentally targeted, cost-effective, and feasible to implement.
Grounded in the self-determination theory of motivation and the Six Core Elements of HCT, the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program is designed to meet the diabetes self-management, psychosocial, and HCT needs of emerging adults. The AHEAD Program works to meet EA needs by 1) providing tailored education based on self-identified gaps in diabetes knowledge, nutrition skills, insulin management, and health behaviors, 2) addressing psychological needs through integrated mental health screening and care provided by an embedded AHEAD psychologist, 3) meeting HCT needs by health care navigation education delivered by an embedded AHEAD social worker, and 4) providing a medical visit structure that supports a gradual transfer of responsibilities from the caregiver to the emerging adult.
In a large single-arm study conducted with real-world providers, AHEAD Program improved hemoglobin A1c (A1C), reduced diabetes distress, and increased HCT readiness in emerging adults with T1D. We propose to build on our prior experience and promising preliminary AHEAD Program results to carry out a comprehensive hybrid type 1 effectiveness-implementation study to determine: 1) the AHEAD Program’s effectiveness in improving A1C and time in ranges (TIRs) in a pragmatic randomized controlled trial, 2) the role of diabetes distress and HCT readiness in mediating the effect of the AHEAD Program on A1C and TIRs, 3) the cost-effectiveness of the AHEAD Program, and 4) barriers and facilitators to AHEAD Program implementation and participation from the perspectives of the emerging adult and the diabetes care team.
Description of Project
The majority of emerging adults with type 1 diabetes (T1D) do not meet glycemic targets and experience suboptimal psychosocial outcomes. Few evidence-based interventions exist for this group, and fewer still target health care transition (HCT) readiness to support successful transition to independence with chronic disease management. To assist EAs in effectively managing the stressors and challenges of T1D in the context of their everyday lives, we need interventions that are innovative, developmentally targeted, cost-effective, and feasible to implement.
Grounded in the self-determination theory of motivation and the Six Core Elements of HCT, the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program is designed to meet the diabetes self-management, psychosocial, and HCT needs of emerging adults. The AHEAD Program works to meet EA needs by 1) providing tailored education based on self-identified gaps in diabetes knowledge, nutrition skills, insulin management, and health behaviors, 2) addressing psychological needs through integrated mental health screening and care provided by an embedded AHEAD psychologist, 3) meeting HCT needs by health care navigation education delivered by an embedded AHEAD social worker, and 4) providing a medical visit structure that supports a gradual transfer of responsibilities from the caregiver to the emerging adult.
In a large single-arm study conducted with real-world providers, AHEAD Program improved hemoglobin A1c (A1C), reduced diabetes distress, and increased HCT readiness in emerging adults with T1D. We propose to build on our prior experience and promising preliminary AHEAD Program results to carry out a comprehensive hybrid type 1 effectiveness-implementation study to determine: 1) the AHEAD Program’s effectiveness in improving A1C and time in ranges (TIRs) in a pragmatic randomized controlled trial, 2) the role of diabetes distress and HCT readiness in mediating the effect of the AHEAD Program on A1C and TIRs, 3) the cost-effectiveness of the AHEAD Program, and 4) the factors influencing successful implementation in a general diabetes clinic setting.
We hypothesize that AHEAD Program participants will have lower A1C and higher TIRs compared to usual care participants and that the AHEAD Program’s effect on A1C and TIRs will be partially mediated through its effect on diabetes distress and HCT readiness. In addition, we hypothesize that the AHEAD Program will be cost-effective.
This proposal offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based behavioral interventions, as well as standards of care for emerging adults with T1D and their families. If AHEAD improves emerging adult diabetes outcomes, is cost-effective, and is feasible to implement in different contexts, this study will result in an innovative, scalable intervention that enhances the long-term health trajectory of this population.
Anticipated Outcome
We hypothesize that AHEAD Program participants will have lower A1C and higher TIRs compared to usual care participants and that the AHEAD Program’s effect on A1C and TIRs will be partially mediated through its effect on diabetes distress and HCT readiness. In addition, we hypothesize that the AHEAD Program will be cost-effective.
Relevance to T1D
This proposal offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based behavioral interventions, as well as standards of care for emerging adults with T1D and their families. If AHEAD improves emerging adult diabetes outcomes, is cost-effective, and is feasible to implement in different contexts, this study will result in an innovative, scalable intervention that enhances the long-term health trajectory of this population.