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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: e-Counseling plus Usual Care; Behavioral: Control

• Registration Number: NCT01541540
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-03-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e-Counseling plus Usual Care	e-Counseling plus Usual Care	-
e-Info Control plus Usual Care	Control	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

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