A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)

This study has been completed.
Sponsor:
Collaborators:
Cape Breton District Health Authority
Pfizer
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01620996
First received: June 13, 2012
Last updated: June 14, 2012
Last verified: June 2008
  Purpose

Study Purpose and Design

The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives

  1. To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
  2. To increase patient compliance with lifestyle aimed at pharmaceutical interventions aimed at decreasing global cardiovascular risk.

Secondary objectives of the study are:

  1. To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
  2. To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
  3. To determine the economic impact of a global risk assessment and management process within a primary care setting.

Condition Intervention Phase
Cardiovascular Risk Reduction of Having a Coronary Event
Behavioral: Minimal Intervention
Behavioral: Motivational Interviewing
Behavioral: Motivational Enhancement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR): A Primary Prevention Initiative Examining The Impact Of Global Risk Factor Assessment & Management On Health Care In Nova Scotia

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • achievement of targeted mean reductions in overal global risk within patient risk strata Proportion of patients achieving their targeted mean reduction in global risk within risk strata [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine the economic impact of a global risk assessment management process within a primary care setting [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • percentage of patients that reduced at least one risk category from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1708
Study Start Date: March 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Duffus Street Medical Centre
Behavioral: Minimal Intervention
There is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).
Behavioral: Motivational Interviewing

Motivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES:

FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism

These mediators/ingredients are delivered by the clinician using the following principles:

Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy

Behavioral: Motivational Enhancement

Motivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model.

The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance

These stages are specific to different behaviours.

Active Comparator: 2
Sydney Family Practice
Behavioral: Minimal Intervention
There is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).
Behavioral: Motivational Interviewing

Motivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES:

FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism

These mediators/ingredients are delivered by the clinician using the following principles:

Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy

Behavioral: Motivational Enhancement

Motivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model.

The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance

These stages are specific to different behaviours.

No Intervention: no counseling
HRA assessment pre and post but no counselling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30 years of age
  • a patient of the primary care practices involved in the study
  • able to provide informed consent

Exclusion Criteria:

  • under the age of 30
  • not a patient of the primary care practices
  • unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620996

Locations
Canada, Nova Scotia
Duffus Health Centre
Halifax, Nova Scotia, Canada, B3L 2C2
Sponsors and Collaborators
Capital District Health Authority, Canada
Cape Breton District Health Authority
Pfizer
  More Information

No publications provided by Capital District Health Authority, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01620996     History of Changes
Other Study ID Numbers: CD-2005-267
Study First Received: June 13, 2012
Last Updated: June 14, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
preintervention and postintervention cohort longitudinal prospective study

ClinicalTrials.gov processed this record on September 18, 2014