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

NCT01620996 | Completed DMC

• 1 other identifier: CD-2005-267
• Study Type: interventional
• Target: 1,708
• Locations: 1 country
• Sites: 1

Brief 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. 1.To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
2. 2.To increase patient compliance with lifestyle aimed at pharmaceutical interventions aimed at decreasing global cardiovascular risk.
3. 3.To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
4. 4.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.
5. 5.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

Keywords

preintervention and postintervention cohort longitudinal prospective study

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• determine the economic impact of a global risk assessment management process within a primary care setting

  12 months

• percentage of patients that reduced at least one risk category from baseline

  12 months

Study Arms (3)

1

ACTIVE COMPARATOR

Duffus Street Medical Centre

Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement

2

ACTIVE COMPARATOR

Sydney Family Practice

Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement

no counseling

NO INTERVENTION

HRA assessment pre and post but no counselling

Interventions

Minimal Intervention BEHAVIORAL

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).

1; 2

Motivational Interviewing BEHAVIORAL

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

1; 2

Motivational Enhancement BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• under the age of 30
• not a patient of the primary care practices
• unable to provide informed consent

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Cape Breton District Health Authority: collaborator
• Pfizer: collaborator

Study Sites (1)

Duffus Health Centre

Halifax, Nova Scotia, B3L 2C2, Canada

Location

Related Publications (1)

• Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.

  PMID: 23796526 DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: March 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 15, 2022

Record last verified: 2008-06

Locations

CA (1)