The BASIC-S Feasibility Study for Vascular Risk Reduction
NCT07755631 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-08-10
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.
Conditions
- Hypertension (HTN)
- Vascular Diseases
- Stroke
- Dementia
- Cardiovascular Risk Factor
- Cognitive Decline
Interventions
- BEHAVIORAL
-
BASIC-S Intervention
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.
- BEHAVIORAL
-
Standard / Usual Care
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.
Sponsors & Collaborators
-
Academic Medical Organization of Southwestern Ontario
collaborator OTHER -
Andrew Appleton
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2027-07-01
- Completion
- 2027-10-01
Countries
- Canada
Study Locations
More Related Trials
-
The Healthy Options Feasibility Study
NCT00746460 ·Status: COMPLETED ·Phase: NA
-
Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks
NCT01326130 ·Status: UNKNOWN ·Phase: NA
-
Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
NCT03935776 ·Status: UNKNOWN ·Phase: NA
-
Reducing Risk Factors in Peripheral Arterial Disease
NCT00217919 ·Status: COMPLETED ·Phase: NA
-
Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
NCT05599425 ·Status: RECRUITING ·Phase: NA
-
A BCT Intervention for Medication Adherence Among Individuals on Statins
NCT05273736 ·Status: COMPLETED ·Phase: PHASE1
-
Primary Prevention Program
NCT03927196 ·Status: COMPLETED ·Phase: NA
-
Adherence to an Exercise and Healthy Diet Program in Patients With Coronary Heart Disease Aged ≥ 60 Years
NCT06178263 ·Status: COMPLETED
-
CVD Risk Reduction Trial
NCT00473785 ·Status: COMPLETED ·Phase: NA
-
Polygenic Risk Score for Optimizing Primary Prevention in Intermediate-Risk Populations
NCT07039123 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Heart Health Buddies: Peer Support to Decrease CVD Risk
NCT03646656 ·Status: COMPLETED ·Phase: NA
-
Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).
NCT04753281 ·Status: COMPLETED ·Phase: NA
-
Cardiovascular Health And Risk Modification in Family Health Teams
NCT00787306 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
NCT01346189 ·Status: COMPLETED ·Phase: NA
-
Translating Research: Patient Decision Support/Coaching
NCT00416026 ·Status: COMPLETED ·Phase: NA
-
Family-based Frailty Self Management Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure
NCT05765721 ·Status: COMPLETED ·Phase: NA
-
Mobile Application for Cardiovascular Risk Treatment
NCT05712070 ·Status: UNKNOWN ·Phase: NA
-
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
NCT01781416 ·Status: COMPLETED
-
Healthy Heart Habits-2
NCT06440278 ·Status: COMPLETED ·Phase: NA
-
Randomized Controlled Trial of Group Prevention Coaching
NCT01838226 ·Status: COMPLETED ·Phase: NA
-
Improve Medication Adherence Among Stroke Survivors in Rural Kentucky
NCT07084051 ·Status: COMPLETED ·Phase: NA
-
Lifestyle Intervention In CKD
NCT07633145 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk
NCT02035826 ·Status: COMPLETED ·Phase: NA
-
Heart Disease on the Mend
NCT00127751 ·Status: COMPLETED ·Phase: PHASE2
-
Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
NCT03253341 ·Status: COMPLETED ·Phase: NA