Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

NCT ID: NCT00815477

Last Updated: 2012-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Waitlist control with generic Information about lifestyle and hypertension

Group Type ACTIVE_COMPARATOR

Generic Information

Intervention Type BEHAVIORAL

Waitlist control plus educational material on lifestyle behavior and hyptertension

2

Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change.

Group Type EXPERIMENTAL

Web-based lifestyle counseling messages

Intervention Type BEHAVIORAL

10 email messages based on readiness-to-change over a 4 month period

Interventions

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Web-based lifestyle counseling messages

10 email messages based on readiness-to-change over a 4 month period

Intervention Type BEHAVIORAL

Generic Information

Waitlist control plus educational material on lifestyle behavior and hyptertension

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

46 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Stroke Network

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Robert Nolan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert P Nolan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University of Western Ontario

London, Ontario, Canada

Site Status

Grey Bruce Public Health Unit

Owen Sound, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Durrani S, Irvine J, Nolan RP. Psychosocial determinants of health behaviour change in an e-counseling intervention for hypertension. Int J Hypertens. 2012;2012:191789. doi: 10.1155/2012/191789. Epub 2011 Dec 20.

Reference Type RESULT
PMID: 22229083 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22498181 (View on PubMed)

Other Identifiers

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Candian Stroke Network

Identifier Type: -

Identifier Source: secondary_id

06-0422-BE

Identifier Type: -

Identifier Source: org_study_id

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