NCT00694239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

3.8 years

First QC Date

June 6, 2008

Last Update Submit

June 29, 2011

Conditions

HypertensionDyslipidemia

Keywords

hypertensioncompliance

Outcome Measures

Primary Outcomes (1)

  • Medication Compliance

    1 year

Secondary Outcomes (5)

  • Patient perception of cardiovascular risk

    1 year

  • Pilot Feasibility Study

    1 year

  • Blood Pressure

    1 year

  • Cholesterol Level

    1 year

  • Framingham Risk Score (stroke and coronary artery disease)

    1 year

Study Arms (2)

B

NO INTERVENTION

Standard Care

A

EXPERIMENTAL

Risk Assessment plus standard care

Behavioral: Knowledge of Cardiovascular Risk Assessment

Interventions

Knowledge of Cardiovascular Risk AssessmentBEHAVIORAL

Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.

A

Eligibility Criteria

Age30 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Related Links

MeSH Terms

Conditions

HypertensionDyslipidemiasPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bryan J Har, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

  • George K Dresser, PhD, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

May 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

CA(1)