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

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ClinicalTrials.gov Identifier: NCT01541540
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hypertension Behavioral: e-Counseling plus Usual Care Behavioral: Control

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension
Study Start Date : February 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541540


Locations
Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Canada, Ontario
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, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Robert P Nolan, Ph.D Behavioural Cardiology Research Unit, University Health Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01541540     History of Changes
Obsolete Identifiers: NCT01792076
Other Study ID Numbers: 11-0580-BE
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases