An interventional study of BASIC-S Intervention and Standard / Usual Care in Hypertension (HTN), Vascular Diseases and Stroke, sponsored by Andrew Appleton. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Andrew Appleton · Not applicable, Interventional, and Prevention
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.
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 BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support) framework. Grounded in partnering and motivational interviewing principles, BASIC-S is designed to bridge the evidence-to-practice implementation gap and support the translation of research into real-world health behavior change.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Andrew Appleton as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Households allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model.
Behavioral: BASIC-S Intervention
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.
Behavioral: Standard / Usual Care
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.
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.
Also known as: Waitlist, Control
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.
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.
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.
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.
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.
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.
Change in Subjective Cognitive Function (PROMIS)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4a. Raw scores range from 4 to 20, which are translated into standardized T-scores. Higher scores indicate better cognitive function.
Time frame: Baseline and 6 Months
Change in Sleep Disturbance (PROMIS)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 4a. Raw scores range from 4 to 20, translated into standardized T-scores. Higher scores indicate greater sleep disturbance.
Time frame: Baseline and 6 Months
Change in Physical Activity (PAVS)
Measured using the Physical Activity Vital Sign (PAVS). Calculated by multiplying the reported days of physical activity per week by the reported minutes per day, yielding a total of moderate-to-vigorous physical activity minutes per week.
Time frame: Baseline and 6 Months
Change in Social Connectivity (LSNS-6)
Measured using the Lubben Social Network Scale-6 (LSNS-6). Contains 6 items scored from 0 to 5. Total scores range from 0 to 30, with higher scores indicating stronger social networks and lower risk of isolation.
Time frame: Baseline and 6 Months
Change in Dietary Quality (STC)
Measured using the 8-item Starting The Conversation (STC) Dietary Tool. Total scores range from 0 to 16, with higher scores indicating poorer dietary quality (greater consumption of unhealthy foods).
Time frame: Baseline and 6 Months
Plan to share: Yes — De-identified individual participant data (IPD) collected during the trial will be made available to qualified researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available beginning 9 months and ending 36 months following article publication.
Access criteria: Data access requests will be reviewed by the Principal Investigator and the study steering committee. Requestors must provide a formal research proposal and statistical analysis plan. To protect the privacy of this occupational cohort, access will require a formal Data Sharing Agreement (DSA) approved by the London Health Sciences Centre Research Institute (LHSCRI) contracts office. Proposals should be directed to the Principal Investigator at andrew.appleton@lhsc.on.ca.
Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 9 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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