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Completed

NCT Number: NCT01541540

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-Counseling plus Usual Care

Behavioral

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.

Control

Behavioral

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.

Primary outcomes

  1. Blood Pressure

    Time frame: 12-month

    Systolic blood pressure, diastolic blood pressure, pulse pressure

  2. lipoprotein cholesterol

    Time frame: 12-month

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

  3. 10-year absolute risk for Cardiovascular Heart Disease.

    Time frame: 12-month

Secondary outcomes

  1. 4-day step count recorded by accelerometry

    Time frame: 12-month

  2. 24-hour urinary sodium excretion

    Time frame: 12-month

  3. salivary cotinine

    Time frame: 12-month

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

  4. Fruit and vegetable intake

    Time frame: 12-month

    Diet History Questionnaire

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: REACH

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2012
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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