NCT00787306

Brief Summary

Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor control currently in clinical practice. This study will evaluate the ability of a different model of risk factor care using other health providers assisting family doctors, along with information aids for patients and health professionals,to achieve better levels of cardiovascular risk factor control in adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

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

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

November 6, 2008

Last Update Submit

March 31, 2018

Conditions

Keywords

chronic disease managementdecision aidscardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • mean systolic blood pressure

    6 months

Secondary Outcomes (1)

  • Proportion of adults with 3 cardiovascular risk factors under optimal control

    6 months

Study Arms (2)

Multi-faceted Cardiovascular Decision Support

EXPERIMENTAL

Risk factor active surveillance, multi-disciplinary disease management and decision aid intervention

Behavioral: Active risk factor surveillance

Control Usual Care

OTHER

Usual care in a wait-list control arm that receives the experimental intervention after 6 months.

Behavioral: Active risk factor surveillance

Interventions

Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal

Control Usual CareMulti-faceted Cardiovascular Decision Support

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 50 to 80 years of age
  • having attending a family medicine clinic for more than one year

You may not qualify if:

  • not able to participate for one year
  • not able to read English
  • requires house calls
  • nursing home resident
  • cognitive impairment
  • current chest pain or symptoms of active coronary heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Granovsky Gluskin Family Medicine Cwntre

Toronto, Ontario, M5T 3L9, Canada

Location

MeSH Terms

Conditions

HypertensionHyperlipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Warren J McIsaac, MD

    Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations