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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: e-Counseling plus Usual Care
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-Counseling plus Usual Care<br> | Behavioral: e-Counseling plus Usual Care<br>* 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.<br>|
| Active Comparator: e-Info Control plus Usual Care<br> | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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