Risk Assessment and Treat Compliance in Hypertension Educ... | NCT00694239

Studies
Risk Assessment and Treat Compliance in Hypertension Education Trial

NCT00694239

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Jun 30, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hypertension
Dyslipidemia

Interventions

Knowledge of Cardiovascular Risk Assessment

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
13014E	Other Identifier	REB

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 6, 2008

First Submission Date that Met QC Criteria

Jun 6, 2008

First Posted Date

Jun 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2011

Last Update Posted Date

Jun 30, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	No Intervention	Standard Care
A	Experimental	Risk Assessment plus standard care	Behavioral: Knowledge of Cardiovascular Risk Assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knowledge of Cardiovascular Risk Assessment	Behavioral	Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication Compliance		1 year

Secondary Outcomes

Measure	Description	Time Frame
Patient perception of cardiovascular risk		1 year
Pilot Feasibility Study		1 year
Blood Pressure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryan J Har, MD	Western University, Canada	Principal Investigator
George K Dresser, PhD, MD	Western University, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Western Ontario		London	Ontario	N6A 5A5	Canada

References Module

Citations

Not provided

Label	URL
Physicians Services Incorporated	View source
University of Western Ontario	View source

ID	Term
D006973	Hypertension
D050171	Dyslipidemias
D010349	Patient Compliance

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases