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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815477
First Posted: December 30, 2008
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Stroke Network
Information provided by (Responsible Party):
Robert Nolan, University Health Network, Toronto
  Purpose
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).

Condition Intervention Phase
Hypertension Behavioral: Web-based lifestyle counseling messages Behavioral: Generic Information Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment

Further study details as provided by Robert Nolan, University Health Network, Toronto:

Primary Outcome Measures:
  • Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure [ Time Frame: 4 months ]

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

Enrollment: 387
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   46 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815477


Locations
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 3K7
Grey Bruce Public Health Unit
Owen Sound, Ontario, Canada, N4K 4K5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Stroke Network
Investigators
Principal Investigator: Robert P Nolan, Ph.D. University Health Network, Toronto
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Nolan, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00815477     History of Changes
Other Study ID Numbers: 06-0422-BE
Candian Stroke Network
First Submitted: December 29, 2008
First Posted: December 30, 2008
Last Update Posted: February 20, 2012
Last Verified: February 2012