Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment (I-START)

University Health Network, Toronto

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypertension

Treatments: Behavioral: Generic Information; Behavioral: Web-based lifestyle counseling messages

Study type: Interventional

Funder types: Other

Identifiers

NCT00815477

06-0422-BE

Candian Stroke Network

Details and patient eligibility

About

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).

Enrollment: 387 patients

Sex: All

Ages: 46 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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387 participants in 2 patient groups

1

Active Comparator group

Description:

Waitlist control with generic Information about lifestyle and hypertension

Treatment:

Behavioral: Generic Information

2

Experimental group

Description:

Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change.

Treatment:

Behavioral: Web-based lifestyle counseling messages