NCT00815477

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Sep 2007

Typical duration for phase_2 hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

December 29, 2008

Last Update Submit

February 17, 2012

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure

    4 months

Secondary Outcomes (2)

  • Lifestyle Behavior: exercise and diet assessed by questionnaire

    4 months

  • laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity

    4 months

Study Arms (2)

1

ACTIVE COMPARATOR

Waitlist control with generic Information about lifestyle and hypertension

Behavioral: Generic Information

2

EXPERIMENTAL

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

Behavioral: Web-based lifestyle counseling messages

Interventions

Web-based lifestyle counseling messagesBEHAVIORAL

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

2
Generic InformationBEHAVIORAL

Waitlist control plus educational material on lifestyle behavior and hyptertension

1

Eligibility Criteria

Age46 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1 OR Stage 2 hypertension
  • years of age
  • able to read \& write English or French
  • living in private residence

You may not qualify if:

  • Cardiovascular disease
  • Major psychiatric disorder (e.g. psychosis)
  • Dependence on Alcohol or Drugs with in past year
  • Diabetes \>= 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Grey Bruce Public Health Unit

Owen Sound, Ontario, N4K 4K5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22229083RESULT

  • 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.

    PMID: 22498181DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Robert P Nolan, Ph.D.

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

CA(3)