Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014