e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension

Overview

This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and adherence to prescribed medications. Finally, we will quantify the amount of e-counseling support that is required during REACH to evoke a significant reduction in blood pressure. It is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide information that is critical to our understanding of how internet-based programs can help to improve blood pressure and to reduce the risk for cardiovascular disease.

Full Title of Study: “Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2016

Interventions

  • Behavioral: e-Counseling plus Usual Care
    • 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12. Each email will contain an e-link to lifestyle counseling activities designed to enhance motivation and skill to initiate and maintain lifestyle change. e-Counseling includes video-based education and counseling as well as e-tools to self-monitor and reinforce adherence to self-management behavior for exercise, diet, prescribed medications and smoke-free living.
  • Behavioral: Control
    • The control group will receive general educational material on heart healthy living. 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12.

Arms, Groups and Cohorts

  • Experimental: e-Counseling plus Usual Care
  • Active Comparator: e-Info Control plus Usual Care

Clinical Trial Outcome Measures

Primary Measures

  • Blood Pressure
    • Time Frame: 12-month
    • Systolic blood pressure, diastolic blood pressure, pulse pressure
  • lipoprotein cholesterol
    • Time Frame: 12-month
    • total, low-density, and total/high-density ratio
  • 10-year absolute risk for Cardiovascular Heart Disease.
    • Time Frame: 12-month

Secondary Measures

  • 4-day step count recorded by accelerometry
    • Time Frame: 12-month
  • 24-hour urinary sodium excretion
    • Time Frame: 12-month
  • salivary cotinine
    • Time Frame: 12-month
    • smoke-free living measured by salivary cotinine. Measured only in smokers
  • Fruit and vegetable intake
    • Time Frame: 12-month
    • Diet History Questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • Age: 35-74 years – Diagnosis of hypertension: Medication or physician confirmation – Baseline BP in lab: >=140/90 (if no meds); >=130/85 (if on meds) – If medications, prescription unchanged >=2 months Comprehension of English (oral and written) Exclusion Criteria:

  • diagnosis of clinically significant arrhythmia, sleep apnea, kidney disease, major psychiatric illness (eg. psychosis), alcohol or drug dependence in the previous year; institutional residence, or an inability to comprehend English

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert P Nolan, Ph.D, Principal Investigator, Behavioural Cardiology Research Unit, University Health Network

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