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

February 17, 2012
July 23, 2013
February 2012
July 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01541540 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Hypertension
  • 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.
  • 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.
  • Experimental: e-Counseling plus Usual Care
    Intervention: Behavioral: e-Counseling plus Usual Care
  • Active Comparator: e-Info Control plus Usual Care
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
528
Not Provided
July 2015   (final data collection date for primary outcome measure)

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
Both
35 Years to 74 Years
No
Contact: Helena Surikova 416-340-4800 ext 6400 jelena.surikova@uhn.ca
Canada
 
NCT01541540
11-0580-BE
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Robert P Nolan, Ph.D Behavioural Cardiology Research Unit, University Health Network
University Health Network, Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP