search
Back to results

Cardiovascular Health And Risk Modification in Family Health Teams (Multi-CHARM)

Primary Purpose

Cardiovascular Risk Factors, Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Active risk factor surveillance
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors focused on measuring chronic disease management, decision aids, cardiovascular risk factors

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Granovsky Gluskin Family Medicine Cwntre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multi-faceted Cardiovascular Decision Support

Control Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

mean systolic blood pressure

Secondary Outcome Measures

Proportion of adults with 3 cardiovascular risk factors under optimal control

Full Information

First Posted
November 6, 2008
Last Updated
March 31, 2018
Sponsor
University of Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT00787306
Brief Title
Cardiovascular Health And Risk Modification in Family Health Teams
Acronym
Multi-CHARM
Official Title
Multidisciplinary Cardiovascular Health And Risk Modification in Family Health Teams
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Hypertension, Hyperlipidemia, Diabetes
Keywords
chronic disease management, decision aids, cardiovascular risk factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-faceted Cardiovascular Decision Support
Arm Type
Experimental
Arm Description
Risk factor active surveillance, multi-disciplinary disease management and decision aid intervention
Arm Title
Control Usual Care
Arm Type
Other
Arm Description
Usual care in a wait-list control arm that receives the experimental intervention after 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Active risk factor surveillance
Intervention Description
Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
Primary Outcome Measure Information:
Title
mean systolic blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of adults with 3 cardiovascular risk factors under optimal control
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults 50 to 80 years of age having attending a family medicine clinic for more than one year Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren J McIsaac, MD
Organizational Affiliation
Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Granovsky Gluskin Family Medicine Cwntre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiovascular Health And Risk Modification in Family Health Teams

We'll reach out to this number within 24 hrs