The BASIC-S Feasibility Study for Vascular Risk Reduction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrew Appleton

About this trial

Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

The primary applicant (not their partner, if applicable) must be within two years before or after their retirement date.

Spouse or cohabitating partner of an enrolled primary participant. Cohabitating partners may include a common-law partner, adult child, close friend, or roommate who lives with the primary participant and shares common health goals. Enrollment of partners is optional but strongly encouraged.

Capable of providing informed consent.

Disqualifiers

Medical conditions that preclude safe participation in physical activity (for instance, unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.

Active or unstable psychiatric illness, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. Participants with stable, medically managed psychiatric conditions remain eligible.

Severe cognitive impairment that compromises the ability to provide informed consent or independently use study-related technology.

Inability to read and understand English sufficiently to provide informed consent and complete study procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BASIC-S Intervention

    Behavioral

    Participants attend an initial 45-minute goal-setting session with a certified wellness coach. Subsequent support includes an interactive BASIC-S Digital Workbook, automated twice-weekly motivational and educational SMS messages via Twilio, and biweekly (every two weeks) 15-20 minute face-to-face secure video booster sessions (via Microsoft Teams) using motivational interviewing. Intervention households receive a validated automated home blood pressure monitor at baseline.

  • Standard / Usual Care

    Behavioral

    Participants are instructed to continue routine medical follow-up as directed by their primary care providers. To serve as a true comparator, no study-specific behavioral prompts or educational materials are provided during the active 6-month study period. To maximize ethical benefit (waitlist control), control households receive the complete BASIC-S Digital Workbook and a validated automated home blood pressure monitor at the conclusion of their 6-month follow-up visit.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: BASIC-S Intervention GroupExperimental treatment 1 intervention
Group B: Standard Care (Usual Care) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Feasibility operationalized as the proportion of eligible individuals approached who consent to enroll in the trial.

Time frame
At the conclusion of the 5-month recruitment period.
2

Retention Rate

Feasibility operationalized as the proportion of enrolled participants who complete the final 6-month follow-up assessment.

Time frame
At 6 months post-randomization.

Secondary outcomes

1

Change in Integral Brain Health (IBH) Index Score

A 3-item self-report scale assessing perceived cognition, mood, and social connection. Each item is scored 1-5. Total scores range from 3 to 15, with higher scores indicating better self-perceived brain health.

Time frame
Baseline, 3 Months, 6 Months.
2

Change in BASIC-S Implementation Index Score

A 5-domain self-report scale quantifying adherence to core lifestyle domains (Blood pressure, Activity, Sleep, Interaction, and Consumption). Scored using a hierarchically weighted system based on goal attainment (0.0 to 3.0 points per domain). Total score ranges from 0 to 15, with higher scores indicating greater lifestyle adherence. Support serves as a distinct implementation enhancer (scored separately from 0.0 to 3.0).

Time frame
Baseline, 3 Months, 6 Months.
3

Change in Systolic Blood Pressure

Measured using a standardized automated oscillometric device (average of 3 readings after a 5-minute seated rest). The unit of measure is millimeters of mercury (mmHg).

Time frame
Baseline, 3 Months, 6 Months.
4

Change in Subjective Well-Being (WHO-5)

Measured using the World Health Organization-5 (WHO-5) Well-Being Index. The scale contains 5 items, each scored from 0 to 5. Total raw scores range from 0 to 25 and are multiplied by 4 to generate a percentage score (0-100), with higher scores representing better well-being.

Time frame
Baseline and 6 Months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andrew Appleton

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Academic Medical Organization of Southwestern Ontario

Collaborator

This trial is not recruiting at the moment. You can still explore other options: