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| Sponsors and Collaborators: |
University Health Network, Toronto Canadian Stroke Network |
|---|---|
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00815477 |
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 |
|---|---|
|
Hypertension |
Behavioral: Web-based lifestyle counseling messages Behavioral: Generic Information |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | I-START: Internet-Based Strategic Transdisciplinay Approach to Risk Reduction And Treatment |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Waitlist control with generic Information about lifestyle and hypertension
|
Behavioral: Generic Information
Waitlist control plus educational material on lifestyle behavior and hyptertension
|
|
2: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Adriana Mechetiuc, M.D., Ph.D. | 416-340-4800 ext 6038 | adriana.mechetiuc@uhn.on.ca |
| Canada, Ontario | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Adriana Mechetiuc, M.D., Ph.D. 416-340-4800 ext 6038 adriana.mechetiuc@uhn.on.ca | |
| Principal Investigator: Robert P. Nolan, Ph.D. | |
| Grey Bruce Public Health Unit | Recruiting |
| Owen Sound, Ontario, Canada, N4K 4K5 | |
| Contact: Cathy Coburn, BSn Nursing ccoburn@publichealthgreybruce.on.ca | |
| Principal Investigator: Hazel Lynn, M.D. | |
| University of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 3K7 | |
| Contact: Arlene Fleischhauer, BSc.N. 519-661-2111 ext 85759 afleisc@uwo.ca | |
| Principal Investigator: Kevin J Shoemaker, Ph.D. | |
| Principal Investigator: | Robert P Nolan, Ph.D. | University Health Network, Toronto |
More Information
| Responsible Party: | University Health Network ( Robert P. Nolan/Director Behavioural Cardiology Research Unit ) |
| Study ID Numbers: | 06-0422-BE, Candian Stroke Network |
| Study First Received: | December 29, 2008 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00815477 |
| Health Authority: | Canada: Ethics Review Committee |
|
Vascular Diseases Hypertension |
|
Cardiovascular Diseases |
