The BASIC-S Feasibility Study for Vascular Risk Reduction

Sponsor
Andrew Appleton
Study ID
NCT07755631
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Risk Factor
  • Cognitive Decline
  • Dementia
  • Hypertension (HTN)
  • Stroke
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: BASIC-S Intervention Group
    Households allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model.
  • Active Comparator: Standard Care (Usual Care) Group
    Households allocated to this arm receive pure usual care to serve as a real-world comparator, continuing their routine healthcare and access to institutional wellness resources.

Primary Outcome Measure

Recruitment Rate [ Time Frame: At the conclusion of the 5-month recruitment period. ]

Central Contacts

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