Risk Assessment and Treat Compliance in Hypertension Education Trial (RATCHET)

June 29, 2011 updated by: Lawson Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Essential hypertension (new diagnosis or established diagnosis) meeting criteria for pharmacologic therapy as defined by current guidelines

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: B
Standard Care
Experimental: A
Risk Assessment plus standard care
Behavioral: Knowledge of Cardiovascular Risk Assessment
Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication Compliance
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient perception of cardiovascular risk
Time Frame: 1 year
1 year
Pilot Feasibility Study
Time Frame: 1 year
1 year
Blood Pressure
Time Frame: 1 year
1 year
Cholesterol Level
Time Frame: 1 year
1 year
Framingham Risk Score (stroke and coronary artery disease)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada
The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Bryan J Har, MD, Western University, Canada
  • Principal Investigator: George K Dresser, PhD, MD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-07-053
  • 13014E (Other Identifier: REB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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