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

University Health Network, Toronto264 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

264

Conditions

Hypertension

Interventions

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (4)

Vancouver Coastal Health

Vancouver, British Columbia, Canada

London Health Science Center

London, Ontario, Canada

Grey Bruce Health Unit

Owen Sound, Ontario, Canada

University Health Network (Toronto Gen Hosp Site)

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Blood Pressure

Systolic blood pressure, diastolic blood pressure, pulse pressure

Time frame: 12-month

lipoprotein cholesterol

total, low-density, and total/high-density ratio

Time frame: 12-month

10-year absolute risk for Cardiovascular Heart Disease.

Time frame: 12-month

Secondary Outcomes

4-day step count recorded by accelerometry

Time frame: 12-month

24-hour urinary sodium excretion

Time frame: 12-month

salivary cotinine

smoke-free living measured by salivary cotinine. Measured only in smokers

Time frame: 12-month

Fruit and vegetable intake

Diet History Questionnaire

Time frame: 12-month