REACH- Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension

  • participants needed
  • sponsor
    University Health Network, Toronto
Updated on 7 November 2020


This randomized controlled trial will evaluate whether preventive e-Counseling (Heart and Stroke Foundation Action Plan, HSF-AP; improves blood pressure and lifestyle adherence among subjects diagnosed with Stage 1 or 2 hypertension. Primary hypotheses. 1. e-Counseling (vs. Control) will significantly reduce SBP, DBP and pulse pressure (PP) at the 4-, 12-month outcomes, as measured by a validated protocol for automated BP assessment in the clinic23 which we have used in a previous trial.24 2. e-Counseling (vs. Control) will significantly reduce CVD risk, as measured by lipoprotein cholesterol (total, low-density, and total/high-density ratio) and the Framingham 10-year absolute CHD risk index.25 Secondary hypotheses: 1. e-Counseling (vs. Control) will significantly increase adherence to self-management behaviors at the 4- and 12-month outcomes, as measured by objective and validated indices: - mean 7-day step count recorded by accelerometry - dietary sodium ≤ 100 mmol/day measured by 24-hour urinary sodium - smoke-free living measured by salivary cotinine - fruit and vegetable intake ≥ 9 to12 servings/day, dietary fat < 25% and 2-3 dairy servings/day as measured by an NIH/NCI assessment26 that has been validated for Canadian samples.27.28 - physical activity ≥150 minutes/week as measured by validated assessment29 2. Among subjects who are prescribed antihypertensive medications at baseline, e-Counseling (vs. Control) will significantly increase medication adherence as defined by pharmacy refill data and a validated medication compliance index that we have utilized in a previous trial.30 c.) Physical fitness is measured by the 6-minute walk test d.) Autonomic function and baroreceptor sensitivity are measured by ECG and finometer


Individuals with elevated systolic blood pressure (SBP) are at increased risk for cardiovascular disease (CVD; Risk Ratio, RR = 1.47; 95% CI, 1.24-1.74), stroke (RR, 1.42; 95% CI, 1.03-1.93), coronary heart disease (CHD; RR, 1.44; 95% CI, 1.18-1.77), heart failure (HF; RR, 1.60; 95% CI, 1.15-2.22), and CVD mortality (RR, 1.57; 95% CI, 1.24-2.00).1 Hypertension is prevalent among 19 to 21% of Canadian adults 20-79 years of age, and its prevalence rises to 53% among adults 60-79 years of age2, 3, and higher among elderly adults. Hypertension is treated and controlled among only 66% of Canadian adults (SBP < 140, diastolic BP, DBP, < 90 mmHg).2, 3 This is concerning since the risk of cardiovascular mortality among adults 40-69 years of age rises with elevated BP, doubling with each increase of 20 mmHg systolic or 10 mmHg diastolic, from the base index of 115/75 mmHg.

Condition Hypertension
Treatment E-counselling, e-info and usual care
Clinical Study IdentifierNCT01792076
SponsorUniversity Health Network, Toronto
Last Modified on7 November 2020


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