The BASIC-S Feasibility Study for Vascular Risk Reduction (NCT07755631) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The BASIC-S Feasibility Study for Vascular Risk Reduction
Canada120 participantsStarted 2026-10-01
Plain-language summary
Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed the BASIC-S 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate
Timeframe: At the conclusion of the 5-month recruitment period.