The BASIC-S Feasibility Study for Vascular Risk Reduction

Background and Rationale:High blood pressure, inactivity, poor sleep, social isolation, and unhealthy diets drivestroke, heart disease, and dementia. As dementia rates plateau and cardiovasculardiseases rise, current public health strategies are stalling. The 2025 HypertensionCanada guidelines lowered the threshold for hypertension to 130/80 mm Hg (target <130 mmHg), vastly increasing the population needing management. However, translating lifestylerisk reduction into routine care is hindered by fragmented clinical workflows and a lackof behavioral support.To address this, we developed BASIC‐S (Blood Pressure, Activity, Sleep, Interaction,Consumption, and Support) framework. Grounded in partnering and motivational interviewingprinciples, BASIC‐S is designed to bridge the evidence‐to‐practice implementation gap andsupport the translation of research into real‐world health behavior change.Study Design and Setting:This study is a single‐center, mixed‐methods, cluster‐randomized pilot trial conducted atthe London Health Sciences Centre (LHSC). Randomization occurs at the household level,enrolling either individual employees or employee‐partner pairs. Households arerandomized 1:1 to either the BASIC‐S intervention or standard care for six months.Statistical Analysis Plan:Analyses will be conducted at the individual participant level, with the primarytimepoint for comparison being 6 months. To account for the potential clustering effectsof households, continuous outcome data will be analyzed using mixed models for repeatedmeasures, incorporating a random intercept for the household. Sensitivity to thenormality assumptions of continuous outcomes will be assessed using rank‐based methodsdesigned for cluster‐randomized trials. Discrete outcomes will be evaluated using ageneralized estimating equations (GEE) approach alongside applicable rank‐based methods.The standard deviation of the change scores and the intraclass correlation coefficient(ICC) will be estimated to inform power calculations for the future definitive trial. Toassess convergent validity, correlation coefficients (e.g., Pearson or Spearman) will becalculated between the novel indices and established psychometric reference scales.Qualitative transcripts will undergo thematic analysis by two independent coders tosystematically classify barriers, facilitators, and overall acceptability.