Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Canadian Stroke Network
Information provided by (Responsible Party):
Robert Nolan, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00815477
First received: December 29, 2008
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lifestyle Behavior: exercise and diet assessed by questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   46 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Health Network, Toronto

Additional 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
Study First Received: December 29, 2008
Last Updated: February 17, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013