HypertensionPhase 2/3I-STARTNCT00815477
Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment
A Phase 2/3 study testing Web-based lifestyle counseling messages and Generic Information in people with Hypertension, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 46 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Web-based lifestyle counseling messages and Generic Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2007to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 OR Stage 2 hypertension
- 46 -74 years of age
- able to read \& write English or French
- living in private residence
Who cannot join
- Cardiovascular disease
- Major psychiatric disorder (e.g. psychosis)
- Dependence on Alcohol or Drugs with in past year
- Diabetes >= 5 years
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Western Ontario
London, Ontario, N6A 3K7
Grey Bruce Public Health Unit
Owen Sound, Ontario, N4K 4K5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: 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).
- Conditions
- Hypertension
- Being tested
- Web-based lifestyle counseling messages, Generic Information
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based lifestyle counseling messagesBehavioural
10 email messages based on readiness-to-change over a 4 month period
Generic InformationBehavioural
Waitlist control plus educational material on lifestyle behavior and hyptertension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Waitlist control with generic Information about lifestyle and hypertension Receives: Behavioral: Generic Information |
| 2 | Experimental | Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change. Receives: Behavioral: Web-based lifestyle counseling messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
Measured: 4 months
Secondary outcomes (2)
Lifestyle Behavior: exercise and diet assessed by questionnaire
Measured: 4 months
laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Stroke Network
- Responsible party
- Principal investigator, Robert Nolan, University Health Network, Toronto
- Investigators
- Robert P Nolan, Ph.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815477
- Sponsor's protocol ID
- 06-0422-BE
- Other IDs
- Candian Stroke Network
- Acronym
- I-START
- Status last verified
- Feb 2012
- First submitted
- 29 Dec 2008
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22229083Nolan 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.
PubMed 22498181
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment
- ClinicalTrials.gov ID
- NCT00815477
- Acronym / sponsor ID
- I-START / 06-0422-BE
- Conditions
- Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Stroke Network
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Generic InformationWaitlist control with generic Information about lifestyle and hypertension |
| 2 | Experimental | Behavioral: Web-based lifestyle counseling messagesWeb-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change. |
Who may qualify
- Ages
- 46 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage 1 OR Stage 2 hypertension
- 46 -74 years of age
- able to read \& write English or French
- living in private residence
Key exclusion criteria (4 listed)
- Cardiovascular disease
- Major psychiatric disorder (e.g. psychosis)
- Dependence on Alcohol or Drugs with in past year
- Diabetes >= 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based lifestyle counseling messages10 email messages based on readiness-to-change over a 4 month period | Behavioural | 2 |
| Generic InformationWaitlist control plus educational material on lifestyle behavior and hyptertension | Behavioural | 1 |
Primary outcome
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
Time frame: 4 months
2 secondary outcomes
Lifestyle Behavior: exercise and diet assessed by questionnaire
Time frame: 4 months
laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
- Results publication: PubMed 22229083Durrani 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.
- Derived from this study: PubMed 22498181Nolan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Nolan, Ph.D. principal investigator
University Health Network, Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Web-based lifestyle counseling messages and Generic Information in people with Hypertension, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.