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

October 6, 2016 updated by: University Health Network, Toronto

Reducing Risk With E-based Support for Adherence to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver Coastal Health
    • Ontario
      • London, Ontario, Canada
        • London Health Science Center
      • Owen Sound, Ontario, Canada
        • Grey Bruce Health Unit
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network (Toronto Gen Hosp Site)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: e-Counseling plus Usual Care
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.
ACTIVE_COMPARATOR: e-Info Control plus Usual Care
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Robert P Nolan, Ph.D, Behavioural Cardiology Research Unit, University Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

March 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0580-BE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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