Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

Phase 2

Completed

• Conditions: Hypertension

• Registration Number: NCT00815477
• Lead Sponsor: University Health Network, Toronto

Brief Summary

I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Stage 1 OR Stage 2 hypertension
• 46 -74 years of age
• able to read & write English or French
• living in private residence

Exclusion Criteria

• Cardiovascular disease
• Major psychiatric disorder (e.g. psychosis)
• Dependence on Alcohol or Drugs with in past year
• Diabetes >= 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure	4 months

Secondary Outcome Measures

Name	Time	Method
Lifestyle Behavior: exercise and diet assessed by questionnaire	4 months
laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity	4 months

Trial Locations

Locations (3)

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Grey Bruce Public Health Unit; 🇨🇦 Owen Sound, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada