Though rates of death from cardiovascular disease (CVD) have declined the risk of CVD events increased among those with diabetes. Clinical trials have shown behavioral lifestyle interventions are effective at decreasing CVD risk and decreasing CVD-related deaths among those with diabetes. Face-to-face interventions are labor and cost intensive, but may not be more effective than alternative modes of delivery, especially where access and transportation are a significant problem. Studies have shown that telephone- delivered interventions are effective but, more importantly, that patients likely prefer health education via a technology modality. The telephone (either landline or cell phone) is highly accessible for low-income populations. Yet, there is little data on the effectiveness of CVD risk reduction interventions using a novel tablet-based approach among high-risk, low-income African Americans (AA) with diabetes. This study will determine the effectiveness of a multi-component, Tablet-Aided BehavioraL intervention EffecT on Self- management (TABLETS) intervention on changing behavioral (chronic disease self-management) and clinical outcomes (CVD risk) given the needs of a low-income minority population with diabetes at high risk for CVD. We propose a pilot randomized clinical trial to examine the feasibility and efficacy of a theory-driven, multi- component TABLET intervention on improving behavioral outcomes (activity, diet, medication adherence, self-monitoring) and clinical outcomes in high-risk, low-income AAs with diabetes. The primary outcome is change in CVD risk behaviors at 6 months of follow-up and secondary outcomes are glycemic control (A1c), blood pressure, and lipids as well as quality of life. The proposed novel approach will maximize the effectiveness and impact of the intervention by implementing tablet-based videoconferencing as an enhancement of the intervention. This study targets a high-priority research area - disparate burden of type 2 diabetes, resulting from poor self- management. The long-term goal of this application is to test novel approaches to lifestyle behavior change that reduce CVD complications and mortality, and eliminate health disparities in high-risk, low-income AA adults with diabetes.
Racial/ethnic differences in cardiovascular disease (CVD) risk factors show African Americans (AA) have up to a two-fold risk of poor control of glycemia, blood pressure, and lipids compared to Whites. Several studies have shown at least equivalent effectiveness of computer-aided, telehealth, and mobile-enabled interventions on improving chronic disease self-management. The proposed study is a logical progression of an earlier study and provides opportunity for the PI (a new, minority investigator) to extend the experience from the diversity supplement to CVD risk reduction in AAs with T2DM using novel technology. This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven, Tablet-Aided BehavioraL intervention EffecT on Self-management (TABLETS) in AAs with diabetes, using real-time videoconferencing technology for education and skills training, on chronic disease self-management behaviors and CVD risk among a high- risk, low-income AA population. The proposed study addresses a high-priority area in diabetes.
| Lynch, Cheryl P; Williams, Joni S; J Ruggiero, Kenneth et al. (2016) Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes. Trials 17:157 |
