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

This study is currently recruiting participants.
Verified July 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01541540
First received: February 17, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention
Hypertension
Behavioral: e-Counseling plus Usual Care
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Systolic blood pressure, diastolic blood pressure, pulse pressure

  • lipoprotein cholesterol [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    total, low-density, and total/high-density ratio

  • 10-year absolute risk for Cardiovascular Heart Disease. [ Time Frame: 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 4-day step count recorded by accelerometry [ Time Frame: 12-month ] [ Designated as safety issue: No ]
  • 24-hour urinary sodium excretion [ Time Frame: 12-month ] [ Designated as safety issue: No ]
  • salivary cotinine [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    smoke-free living measured by salivary cotinine. Measured only in smokers

  • Fruit and vegetable intake [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Diet History Questionnaire


Estimated Enrollment: 528
Study Start Date: February 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541540

Contacts
Contact: Helena Surikova 416-340-4800 ext 6400 jelena.surikova@uhn.ca

Locations
Canada, British Columbia
Vancouver Coastal Health Recruiting
Vancouver, British Columbia, Canada
Contact: Lynn Cunada    604-875-4111      
Sub-Investigator: martin Dawes, M.D         
Canada, Ontario
London Health Science Center Recruiting
London, Ontario, Canada
Contact: Nacy Schmidt    519-663-3626      
Sub-Investigator: Ross Feldman, M.D.         
Grey Bruce Health Unit Recruiting
Owen Sound, Ontario, Canada
Contact: Denna Leach    519-376-9420 ext 1462      
Sub-Investigator: Hazel Lynn, M.D         
University Health Network (Toronto Gen Hosp Site) Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Jelena Surikova    416-340-4800 ext 6400    jelena.surikova@uhn.ca   
Principal Investigator: Robert Nolan, Ph.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Robert P Nolan, Ph.D Behavioural Cardiology Research Unit, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01541540     History of Changes
Obsolete Identifiers: NCT01792076
Other Study ID Numbers: 11-0580-BE
Study First Received: February 17, 2012
Last Updated: July 23, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014