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

NCT01620996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1708

Last updated 2022-11-15

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Risk Reduction of Having a Coronary Event

Interventions

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.

Sponsors & Collaborators

  • Cape Breton District Health Authority

    collaborator UNKNOWN
  • Pfizer

    collaborator INDUSTRY
  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620996 on ClinicalTrials.gov