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

December 29, 2008
February 17, 2012
September 2007
December 2009   (final data collection date for primary outcome measure)
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Lifestyle Behavior: exercise and diet [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00815477 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Laboratory assessment of blood pressure (SBP, DBP, PP) [ 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 ]
Not Provided
Not Provided
 
Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment
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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hypertension
  • Behavioral: Web-based lifestyle counseling messages
    10 email messages based on readiness-to-change over a 4 month period
  • Behavioral: Generic Information
    Waitlist control plus educational material on lifestyle behavior and hyptertension
  • Active Comparator: 1
    Waitlist control with generic Information about lifestyle and hypertension
    Intervention: Behavioral: Generic Information
  • Experimental: 2
    Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change.
    Intervention: Behavioral: Web-based lifestyle counseling messages
Nolan RP, Liu S, Shoemaker JK, Hachinski V, Lynn H, Mikulis DJ, Wennberg RA, Moy Lum-Kwong M, Zbib A. Therapeutic benefit of internet-based lifestyle counselling for hypertension. Can J Cardiol. 2012 May;28(3):390-6. doi: 10.1016/j.cjca.2012.02.012. Epub 2012 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
387
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
46 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00815477
06-0422-BE, Candian Stroke Network
No
Robert Nolan, University Health Network, Toronto
University Health Network, Toronto
Canadian Stroke Network
Principal Investigator: Robert P Nolan, Ph.D. University Health Network, Toronto
University Health Network, Toronto
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP