AzTrials
AzTrials

Cardiovascular Risk Reduction of Having a Coronary EventANCHORNCT01620996

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

A study testing Minimal Intervention, Motivational Interviewing and Motivational Enhancement in people with Cardiovascular Risk Reduction of Having a Coronary Event, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
What is being tested?
Minimal Intervention, Motivational Interviewing and Motivational Enhancement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,708 participants
Where
1 siteCanada
Study dates
Mar 2006to Sep 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Duffus Health Centre

    Halifax, Nova Scotia, B3L 2C2

Other trials in Canada

About this study

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

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

Read more
  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.
Read the detailed description

The Burden of Cardiovascular Disease

Cardiovascular disease (CVD) remains the major cause of mortality in the developed world, accounting for almost 40% of all deaths in both the United States and Canada. It represents a substantial financial drain on society and contributes a significant burden to health care systems that are already under strain. Major modifiable risk factors for CVD include elevated blood pressure, cigarette smoking, elevated total plasma cholesterol and low high-density lipoproteins, diabetes, obesity, and sedentary lifestyle, at least one of which is present in 80% of Canadians. Circulatory diseases (particularly heart disease, stroke and hypertension) cost the Nova Scotia health care system an estimated $961 million dollars per year. In Nova Scotia cardiovascular disease kills an estimated 2,900 Nova Scotians every year accounting for nearly 36% of all deaths in the province.

Cardiovascular Disease Prevention in Primary Care Settings

There is strong evidence linking improved risk factors among populations to improved health outcomes, and both epidemiological and community research have illustrated that the bulk of non-communicable diseases (NCDs) such as CVD are preventable, or at least their occurrence can be postponed. Because primary care physicians are most often the first point of contact for individuals in need of health care, general practice is well placed to facilitate change in patients' risk factor status and ensure more effective treatment of risk factors such as hypertension and hyperlipidemia. Currently primary care service delivery is expanding to include a broader network of providers such as nurses, dieticians, and pharmacists to enable more effective risk factor identification and management, and health promotion and disease prevention efforts across the continuum of care.

Nova Scotia Context

Currently in Nova Scotia, population health and disease prevention initiatives are underway that will support and reinforce the work of the current study, including primary health care transition fund initiatives, and strategic directions from the Office of Health Promotion that address major risk factors for cardiovascular disease. These provincial initiatives together with local projects ongoing in several communities provide an ideal opportunity for interfacing with a primary care global risk reduction initiative.

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 and 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.

The intervention will be led by a study coordinator in each primary care setting and consist of a recruitment strategy, global risk factor assessment, behaviour change counseling, and risk factor management strategies based on the 5A's framework (assess, advise, agree, assist and arrange follow-up). Supports will be provided to study participants in making behaviour changes including counseling and follow-up, behaviour change tools, print resources, group education sessions, and an inventory of and links to community programs. Medication reviews and physician referrals will also be completed as required.

A Steering Committee will guide the project and includes membership from the Principal Investigators, representatives from Pfizer Canada, Capital District Health Authority, the Cape Breton District Health Authority and the Nova Scotia Department of Health; and community stakeholders including community pharmacy, a physician and/or nurse from each site, other relevant allied health professionals (e.g., nutritionist) and the CEO from the Heart and Stroke Foundation of Nova Scotia. The initiative will be conducted over a three-year period and will comprise three phases as outlined in the following table.

Research Methodology

This is a pre-intervention and post-intervention longitudinal, prospective pilot study to evaluate study participants achievement of CVD risk factor reduction. The research will include a combination of quantitative and qualitative data to judge effectiveness of the interventions and to describe the intervention as it is implemented. The effectiveness of the approach will be examined using pre and post measures of key outcome variables. In addition to these outcome measures, process evaluation will monitor and assess the implementation of the interventions. The study will include baselines measurement, periodic assessments of process measures, outcome measurement and follow-up measurement. Following the baseline measurement through the GRA, patients will receive risk management interventions.

The data will be analyzed using both quantitative and qualitative methods. Pre and post outcome measures will be analyzed using descriptive analytical techniques comparing means for continuous measures and proportions for categorical measures. Qualitative data will be managed and analyzed either manually or via QSR NUD*IST (Qualitative Solutions and Research Non-numerical Unstructured Data Indexing Searching and Theory-building) software. The qualitative analysis will consist of both content and thematic analysis.

Sustainability and Dissemination

The project will involve collaboration and integration with primary health care renewal efforts and community resources to build on existing infrastructure and thereby help to facilitate sustainability. Capacity building within primary care settings and mobilization of existing resources will also help to ensure a sustainable resource. Steering Committee members and other partners will ensure the project results and products are shared with their organizations and networks, and also more widely across the province. Project findings will be published in appropriate peer reviewed publications to further share the learning and disseminate findings.

Being tested
Minimal Intervention, Motivational Interviewing, Motivational Enhancement
Keywords
preintervention and postintervention cohort longitudinal prospective study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimal InterventionBehavioural

    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).

  • Motivational InterviewingBehavioural

    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

  • Motivational EnhancementBehavioural

    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.

Study groups in NCT01620996
Study groupRoleWhat they receive
1Active comparatorDuffus Street Medical Centre
Receives: Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement
2Active comparatorSydney Family Practice
Receives: Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement
no counselingNo interventionHRA assessment pre and post but no counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (2)
  1. determine the economic impact of a global risk assessment management process within a primary care setting

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study startMar 2006
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620996
Sponsor's protocol ID
CD-2005-267
Acronym
ANCHOR
Status last verified
Jun 2008
First submitted
13 Jun 2012
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23796526

Questions about this trial

What is this clinical trial studying?

A study testing Minimal Intervention, Motivational Interviewing and Motivational Enhancement in people with Cardiovascular Risk Reduction of Having a Coronary Event, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620996, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in