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

February 17, 2012 updated by: Robert Nolan, University Health Network, Toronto

I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • University of Western Ontario
      • Owen Sound, Ontario, Canada, N4K 4K5
        • Grey Bruce Public Health Unit
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Waitlist control with generic Information about lifestyle and hypertension
Behavioral: Generic Information
Waitlist control plus educational material on lifestyle behavior and hyptertension
Experimental: 2
Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change.
Behavioral: Web-based lifestyle counseling messages
10 email messages based on readiness-to-change over a 4 month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
Time Frame: 4 months
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Stroke Network

Investigators

  • Principal Investigator: Robert P Nolan, Ph.D., University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

December 29, 2008

First Posted (Estimate)

December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2012

Last Update Submitted That Met QC Criteria

February 17, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0422-BE
  • Candian Stroke Network

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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