REACH- Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension

This study is currently recruiting participants.
Verified February 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
Heart & Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01792076
First received: February 12, 2013
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

This randomized controlled trial will evaluate whether preventive e-Counseling (Heart and Stroke Foundation Action Plan, HSF-AP; http://ww2.heartandstroke.ca/hs_bp2.asp?media=bp) improves blood pressure and lifestyle adherence among subjects diagnosed with Stage 1 or 2 hypertension.

Primary hypotheses.

  1. e-Counseling (vs. Control) will significantly reduce SBP, DBP and pulse pressure (PP) at the 4-, 12-month outcomes, as measured by a validated protocol for automated BP assessment in the clinic23 which we have used in a previous trial.24
  2. e-Counseling (vs. Control) will significantly reduce CVD risk, as measured by lipoprotein cholesterol (total, low-density, and total/high-density ratio) and the Framingham 10-year absolute CHD risk index.25

Secondary hypotheses:

  1. e-Counseling (vs. Control) will significantly increase adherence to self-management behaviors at the 4- and 12-month outcomes, as measured by objective and validated indices:

    • mean 7-day step count recorded by accelerometry
    • dietary sodium ≤ 100 mmol/day measured by 24-hour urinary sodium
    • smoke-free living measured by salivary cotinine
    • fruit and vegetable intake ≥ 9 to12 servings/day, dietary fat < 25% and 2-3 dairy servings/day as measured by an NIH/NCI assessment26 that has been validated for Canadian samples.27.28
    • physical activity ≥150 minutes/week as measured by validated assessment29
  2. Among subjects who are prescribed antihypertensive medications at baseline, e-Counseling (vs. Control) will significantly increase medication adherence as defined by pharmacy refill data and a validated medication compliance index that we have utilized in a previous trial.30 c.) Physical fitness is measured by the 6-minute walk test d.) Autonomic function and baroreceptor sensitivity are measured by ECG and finometer

Condition Intervention
Hypertension
Other: E-counselling
Other: e-info and usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: REACH- 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:
  • cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24 hour urinary sodium [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 528
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counselling
e-Counselling videos and emails
Other: E-counselling
E-videos and emails- intervention to assist subjects in lifestyle change to control hypertension
Placebo Comparator: Control
E-info + usual care (control)
Other: e-info and usual care

Detailed Description:

Individuals with elevated systolic blood pressure (SBP) are at increased risk for cardiovascular disease (CVD; Risk Ratio, RR = 1.47; 95% CI, 1.24-1.74), stroke (RR, 1.42; 95% CI, 1.03-1.93), coronary heart disease (CHD; RR, 1.44; 95% CI, 1.18-1.77), heart failure (HF; RR, 1.60; 95% CI, 1.15-2.22), and CVD mortality (RR, 1.57; 95% CI, 1.24-2.00).1 Hypertension is prevalent among 19 to 21% of Canadian adults 20-79 years of age, and its prevalence rises to 53% among adults 60-79 years of age2, 3, and higher among elderly adults. Hypertension is treated and controlled among only 66% of Canadian adults (SBP < 140, diastolic BP, DBP, < 90 mmHg).2, 3 This is concerning since the risk of cardiovascular mortality among adults 40-69 years of age rises with elevated BP, doubling with each increase of 20 mmHg systolic or 10 mmHg diastolic, from the base index of 115/75 mmHg.

  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, heart failure
  • Diagnosis of alcohol or drug abuse within past year
  • Diagnosis of major psychiatric illness: eg. psychosis, bipolar disorder
  • Institutional residence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792076

Contacts
Contact: Robert P Nolan, PhD 416-340-4800 ext 6400 rnolan@uhnres.utoronto.ca
Contact: Arooj Khan, BSc 416-340-4800 ext 4116 arooj.khan@uhn.on.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Martin Dawes, MBBS         martin.dawes@ubc.ca    
Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada
Contact: Ross Feldman, MBBS         ross.feldman@lhsc.ca    
Grey Bruce Public Health Unit Recruiting
Owen Sound, Ontario, Canada
Contact: Hazel Lynn, MBBS         hazel.lynn@greybrucepublichealth.ca    
Sponsors and Collaborators
University Health Network, Toronto
Heart & Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Robert P Nolan, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01792076     History of Changes
Other Study ID Numbers: 0901
Study First Received: February 12, 2013
Last Updated: February 13, 2013
Health Authority: Canada: Research Ethics Board UHN

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013