HypertensionRATCHETNCT00694239
Risk Assessment and Treat Compliance in Hypertension Education Trial
A study testing Knowledge of Cardiovascular Risk Assessment in people with Hypertension and Dyslipidemia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current and recommended target blood pressure levels improves compliance in the management of hypertension. Read more about this study
- Who is it for?
- Ages 30 to 84 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Knowledge of Cardiovascular Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Mar 2011
- Phase
- Interventional
- 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 30 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension (new diagnosis or established diagnosis) meeting criteria for pharmacologic therapy as defined by current guidelines
Who cannot join
- Lack of written informed consent
- Previous myocardial infarction
- Previous stroke
- Congestive heart failure
- Stage 3 or greater chronic kidney disease
- Pregnancy
- Usage of medication bubble/blister package
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Cardiovascular Risk Assessment in Treatment Compliance in Hypertension
The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current and recommended target blood pressure levels improves compliance in the management of hypertension.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Knowledge of Cardiovascular Risk Assessment
- Keywords
- hypertension, compliance
- Medical subject headings
- Hypertension, Dyslipidemias, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge of Cardiovascular Risk AssessmentBehavioural
Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.
| Study group | Role | What they receive |
|---|---|---|
| B | No intervention | Standard Care |
| A | Experimental | Risk Assessment plus standard care Receives: Behavioral: Knowledge of Cardiovascular Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Compliance
Measured: 1 year
Secondary outcomes (5)
Patient perception of cardiovascular risk
Measured: 1 year
Pilot Feasibility Study
Measured: 1 year
Blood Pressure
Measured: 1 year
Cholesterol Level
Measured: 1 year
Framingham Risk Score (stroke and coronary artery disease)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, The Physicians' Services Incorporated Foundation
- Investigators
- Bryan J Har, MD, Principal investigator, Western University, CanadaGeorge K Dresser, PhD, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694239
- Sponsor's protocol ID
- R-07-053
- Other IDs
- 13014E
- Acronym
- RATCHET
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2008
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cardiovascular Risk Assessment in Treatment Compliance in Hypertension
- ClinicalTrials.gov ID
- NCT00694239
- Acronym / sponsor ID
- RATCHET / R-07-053
- Conditions
- Hypertension, Dyslipidemia
- Keywords
- hypertension, compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, The Physicians' Services Incorporated Foundation
- Study start
- May 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jun 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.
The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current and recommended target blood pressure levels improves compliance in the management of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | No intervention | –Standard Care |
| A | Experimental | Behavioral: Knowledge of Cardiovascular Risk AssessmentRisk Assessment plus standard care |
Who may qualify
- Ages
- 30 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension (new diagnosis or established diagnosis) meeting criteria for pharmacologic therapy as defined by current guidelines
Key exclusion criteria (7 listed)
- Lack of written informed consent
- Previous myocardial infarction
- Previous stroke
- Congestive heart failure
- Stage 3 or greater chronic kidney disease
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 |
|---|---|---|
| Knowledge of Cardiovascular Risk AssessmentKnowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months. | Behavioural | A |
Primary outcome
Medication Compliance
Time frame: 1 year
5 secondary outcomes
Patient perception of cardiovascular risk
Time frame: 1 year
Pilot Feasibility Study
Time frame: 1 year
Blood Pressure
Time frame: 1 year
Cholesterol Level
Time frame: 1 year
Framingham Risk Score (stroke and coronary artery disease)
Time frame: 1 year
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 30 Jun 2011.
- Physicians Services IncorporatedLink provided by the sponsor.
- University of Western OntarioLink provided by the sponsor.
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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.
Bryan J Har, MD principal investigator
Western University, Canada
George K Dresser, PhD, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge of Cardiovascular Risk Assessment in people with Hypertension and Dyslipidemia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 1 inclusion and 7 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 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Medication Compliance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2011.