Intervention Design for Individual Behavior Change in Stroke Prevention Trials

Abstract

Stroke prevention requires that patients follow recommended health behaviors. However, few stroke behavioral interventions have been shown to produce clinically significant behavior change in clinical trials, likely thwarted in the design process by limited application of behavioral theoretical models and insight into mechanistic underpinnings during intervention testing. The National Institutes of Health Stage Model for Behavioral Intervention Development provides a systematic, nonlinear, iterative framework for advancing behavioral interventions from theory to practice. Here, we provide an overview of methods from behavioral medicine research that can be applied to improve the development of successful stroke preventive behavioral interventions. Behavioral change theories can provide a conceptual basis for theoretical frameworks for behavioral interventions as they identify individual-level influences on health behaviors using specified constructs tied to underlying psychosocial mechanisms. For example, interventions targeting self-efficacy behaviors for self-management after stroke may be guided by Social Cognitive Theory to deliver patient-centered care. Mixed methods that integrate qualitative and quantitative findings can be useful for identifying key patient barriers to target while designing behavioral interventions, and for evaluating intervention effects, including the extent to which they target putative behavioral mechanisms. Adaptive clinical trial methods such as SMART (Sequential Multiple Assignment Randomized Trials) for identifying optimal intervention sequences and JITAI (Just-in-Time Adaptive Interventions) that leverage real-time contextual data to tailor components can improve potency and personalization of theoretically supported behavioral interventions. Overall, in accordance with the National Institutes of Health Stage Model, successful behavioral trials to advance stroke prevention should be grounded in behavioral theory for intervention development, informed by design methods that enable assessment of behavioral mechanistic targets, and conducted with adaptive clinical trial methodologies to tailor interventions.

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