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

This study has been completed.
Sponsor:
Collaborators:
University of Western Ontario, Canada
The Physicians' Services Incorporated Foundation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00694239
First received: June 6, 2008
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
Dyslipidemia
 Behavioral: Knowledge of Cardiovascular Risk Assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Cardiovascular Risk Assessment in Treatment Compliance in Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Medication Compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient perception of cardiovascular risk [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pilot Feasibility Study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cholesterol Level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Framingham Risk Score (stroke and coronary artery disease) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694239

Locations
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Bryan J Har, MD University of Western Ontario, Canada
Principal Investigator: George K Dresser, PhD, MD University of Western Ontario, Canada
  More Information

Additional Information:
Physicians Services Incorporated  This link exits the ClinicalTrials.gov site
University of Western Ontario  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: George Dresser, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00694239     History of Changes
Other Study ID Numbers: R-07-053, 13014E
Study First Received: June 6, 2008
Last Updated: June 29, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
hypertension
compliance

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013