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

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knowledge of Cardiovascular Risk Assessment
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, compliance

Eligibility Criteria

30 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

B

A

Arm Description

Standard Care

Risk Assessment plus standard care

Outcomes

Primary Outcome Measures

Medication Compliance

Secondary Outcome Measures

Patient perception of cardiovascular risk
Pilot Feasibility Study
Blood Pressure
Cholesterol Level
Framingham Risk Score (stroke and coronary artery disease)

Full Information

First Posted
June 6, 2008
Last Updated
June 29, 2011
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada, The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00694239
Brief Title
Risk Assessment and Treat Compliance in Hypertension Education Trial
Acronym
RATCHET
Official Title
Evaluation of the Effect of Cardiovascular Risk Assessment in Treatment Compliance in Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada, The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia
Keywords
hypertension, compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
No Intervention
Arm Description
Standard Care
Arm Title
A
Arm Type
Experimental
Arm Description
Risk Assessment plus standard care
Intervention Type
Behavioral
Intervention Name(s)
Knowledge of Cardiovascular Risk Assessment
Intervention Description
Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.
Primary Outcome Measure Information:
Title
Medication Compliance
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient perception of cardiovascular risk
Time Frame
1 year
Title
Pilot Feasibility Study
Time Frame
1 year
Title
Blood Pressure
Time Frame
1 year
Title
Cholesterol Level
Time Frame
1 year
Title
Framingham Risk Score (stroke and coronary artery disease)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan J Har, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George K Dresser, PhD, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.psifoundation.org/
Description
Physicians Services Incorporated
URL
http://www.uwo.ca
Description
University of Western Ontario

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Risk Assessment and Treat Compliance in Hypertension Education Trial

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