The BASIC-S Feasibility Study for Vascular Risk Reduction

Background and Rationale:

High blood pressure, inactivity, poor sleep, social isolation, and unhealthy diets drive stroke, heart disease, and dementia. As dementia rates plateau and cardiovascular diseases rise, current public health strategies are stalling. The 2025 Hypertension Canada guidelines lowered the threshold for hypertension to 130/80 mm Hg (target <130 mm Hg), vastly increasing the population needing management. However, translating lifestyle risk reduction into routine care is hindered by fragmented clinical workflows and a lack of behavioral support.

To address this, we developed the BASIC-S framework, targeting Blood pressure, Activity, Sleep, Interaction, Consumption, and Support, using partnering and motivational interviewing to bridge the evidence-to-practice implementation gap.

Study Design and Setting:

This study is a single-center, mixed-methods, cluster-randomized pilot trial conducted at the London Health Sciences Centre (LHSC). Randomization occurs at the household level, enrolling either individual employees or employee-partner pairs. Households are randomized 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 primary timepoint for comparison being 6 months. To account for the potential clustering effects of households, continuous outcome data will be analyzed using mixed models for repeated measures, incorporating a random intercept for the household. Sensitivity to the normality assumptions of continuous outcomes will be assessed using rank-based methods designed for cluster-randomized trials. Discrete outcomes will be evaluated using a generalized 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. To assess convergent validity, correlation coefficients (e.g., Pearson or Spearman) will be calculated between the novel indices and established psychometric reference scales. Qualitative transcripts will undergo thematic analysis by two independent coders to systematically classify barriers, facilitators, and overall acceptability.

Inclusion criteria

• Adults aged 18 years and older currently employed at or recently retired from the London Health Sciences Centre (LHSC) or Western University (with an operational focus on pre-retirees aged 50 years and older).
• Spouse or cohabitating partner of an enrolled primary participant (partner enrollment is optional but strongly encouraged).
• Capable of providing informed consent.
• Access to a mobile device capable of receiving short message service (SMS) communications and viewing PDF documents.
• Physical ability to perform light-to-moderate physical activity.

Exclusion criteria

• Medical conditions precluding safe exercise (e.g., unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.
• Active or unstable psychiatric conditions, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. (Note: Participants with stable, medically managed psychiatric conditions remain eligible).
• Severe cognitive impairment preventing the ability to consent or use study technology.
• Inability to read and understand English.