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

  • STATUS
    Recruiting
  • participants needed
    528
  • sponsor
    University Health Network, Toronto
Updated on 7 November 2020
stroke

Summary

This randomized controlled trial will evaluate whether preventive e-Counseling (Heart and Stroke Foundation Action Plan, HSF-AP; http://ww2.heartandstroke.ca/hs_bp2.asp?media=bp) 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

Description

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.

Details
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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