Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001272987
Ethics application status
Not yet submitted
Date submitted
9/12/2011
Date registered
12/12/2011
Date last updated
12/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Novel Approach to Cardiovascular Health by Optimizing Risk Management: An Intensive Behavioural Intervention Study
Scientific title
Main effects comparison of group based behavioural interventions to reduce cardiac risk in an adult population identified as resistant to change.
Secondary ID [1] 273571 0
Nil
Universal Trial Number (UTN)
Trial acronym
ANCHOR-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Events 279367 0
Condition category
Condition code
Cardiovascular 285555 285555 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will all receive a global risk factor assessment prior to intervention and at the end of the intervention phase (roughly 7 months later). Participants recruited from a previous study that did not show change will be asked to enroll in the current study. The previous study (A Novel Approach to Cardiovascular Health By Optimizing Risk Management: ANCHOR) recruited adults from two family practice offices in Nova Scotia. Each individual received one-on-one behaviour change counselling by a health care provider aimed at reducing cardiac risk. Cardiac risk was assessed utilizing a global risk factor assessment that computed a Framingham score and risk category. The Framingham score was percent measure of 10 year risk of experiencing a cardiac event. Thus, those that were not able to reduce their 10 year risk, will be approached to enrol in the current study.
Additionally, new participants will be recruited from the same health centre. Once an initial assessment is complete, previous participants will be matched to new participants based on several risk indicators and randomly assigned as a dyad.
Each participant will be randomized to one of four group based intervention conditions: 1) Motivation ONLY 2) Awareness building and coping strategy training 3)Combination of above 4) Neither.
New participants that are not matched will receive one-to-one behavioural counseling from a nurse trained in behaviour change counseling.
The group interventions are described below:
Motivational Enhancement
The use of motivational enhancement as an intervention strategy will differ from the ANCHOR Study primarily in format and duration. In the current study, this intervention will be delivered in a small group setting. Each group will be comprised of 5-8 members depending on participant availability. Participants will attend a one hour session, every month, for 6 months. In these small groups, participants will explore the components of motivation as it relates to engaging in and changing health behaviours. Participants will be encouraged to evaluate the behaviours in need of change based on the individualized Heart Risk Assessment feedback given during the initial assessment. Concepts such as stages of change, readiness for change, decisional balance, SMART goals, and relapse prevention will be presented and discussed. Participants will be guided through creating a change plan and will be encouraged to find reinforcers for positive health behaviours. The facilitator will present concepts, guide discussion, and encourage participation utilizing concepts of motivational interviewing and motivational enhancement. The overall goal is to support participants in increasing motivation to engage in positive health behaviours.

Awareness Building and Coping Strategy Training
Participants assigned to this intervention will be presented with material to increase awareness of risks and rewards of health behaviours. The facilitator will guide discussion around increasing awareness of detrimental health behaviours. A problem solving and stress management approach will be utilized to encourage the participants to explore new adaptive coping strategies while reducing the use of maladaptive strategies. The overall goal is to increase distress regarding health behaviours while supporting the participants in problem solving and coping activities that can lead to increasing positive health behaviours.
Intervention code [1] 283871 0
Behaviour
Comparator / control treatment
All intervention groups will be compared to each other as described above. There is no "control" condition in this study
Control group
Active

Outcomes
Primary outcome [1] 286115 0
10 year risk of experiencing a cardiac event as measured by Framingham Risk Points
Timepoint [1] 286115 0
Baseline and Post intervention (approximately 7 months)
Secondary outcome [1] 295177 0
Psychosocial indicators of successful change: Readiness to change, psychological distress, coping strategies, and fatigue. These outcomes will be assessed utilizing psychometrically sound questionnaires.
Timepoint [1] 295177 0
Baseline and Post intervention (approximately 7 months)

Eligibility
Key inclusion criteria
Permanent Nova Scotia resident
Age 30 years of age or older
Previous participant of ANCHOR with a Framingham point total that stayed the same or increased from baseline to post-intervention
Never participated in ANCHOR
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Resident of chronic care facility
Cognitive impairment
Inability to communicate in either official language
Reduction in Framingham points during ANCHOR

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All previous participants of ANCHOR who demonstrated a Framingham score that stayed the same or increased from baseline to post-intervention will be identified and targeted for recruitment. New participants will be identified via the Duffus Health Care Centre.
The method of randomization for the current study begins with the evaluation of previous ANCHOR participants who have completed the initial assessment. Each previous participant will be matched to a new participant based on several factors identified to be predictive of being resistant to change in the preliminary exploratory analysis of the ANCHOR Study.
The variables and ranges they are to be match on are as follows:
Age: matched within range as identified by Framingham risk calculation charts
Gender
BMI: matched within weight classification range as defined by NHLBI guidelines
Readiness: matched within 2 total points on eating healthy, physical activity, and weight
Psychosocial distress: matched within 1 point on total of social support, anger, happiness, and community support
Framingham risk points: matched within 2 points

Each matched dyad (one previous ANCHOR and one new participant) will then be randomly assigned to one of four conditions. Randomization to conditions will continue until all previous ANCHOR participants recruited have been assigned. That is, no unmatched new participant will be randomized to a condition. Any new participant that is unmatched or is recruited in excess of the n recruited from the previous ANCHOR participant pool will be assigned to the 5th condition.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random numbers generator will be utilized to produce an assignment sequence utilizing 1 - 4, but will be constrained to contain the same number of each digit to produce equal groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4004 0
Canada
State/province [1] 4004 0
Nova Scotia

Funding & Sponsors
Funding source category [1] 284352 0
Charities/Societies/Foundations
Name [1] 284352 0
Queen Elizabeth II Foundation
Country [1] 284352 0
Canada
Primary sponsor type
Individual
Name
Michael Vallis, Ph.D., R.Psych.
Address
Capital District Health Authority
Behaviour Change Institute
7071 Bayers Rd, Suite 165
Halifax, NS B3L 2C2
Country
Canada
Secondary sponsor category [1] 283290 0
Individual
Name [1] 283290 0
Claudine Szpilfogel, MSc
Address [1] 283290 0
Research Power Inc.
168 Ochterloney Street
Dartmouth, Nova Scotia
B2Y 1E1
Country [1] 283290 0
Canada
Other collaborator category [1] 260384 0
Individual
Name [1] 260384 0
Dr. Jafna Cox
Address [1] 260384 0
QEII Health Sciences Centre
Division of Cardiology
1796 Summer Street
Halifax, Nova Scotia
B3H 3A7
Country [1] 260384 0
Canada
Other collaborator category [2] 260385 0
Individual
Name [2] 260385 0
Dr. Blair O'Neill
Address [2] 260385 0
University of Alberta Hospital
2C2.36 WMC
8440-112 Street
Edmonton, AB
T6G 2B7
Country [2] 260385 0
Canada
Other collaborator category [3] 260386 0
Individual
Name [3] 260386 0
Dr. Brendan Carr
Address [3] 260386 0
QEII Health Sciences Centre
Room 742
Dickson Building
1276 South Park Street
Halifax, NS B3H 2Y9
Country [3] 260386 0
Canada
Other collaborator category [4] 260387 0
Individual
Name [4] 260387 0
Angela Pfammatter, MSc
Address [4] 260387 0
Partners for Healthier Weight
6960 Mumford Road, Suite 2055
Halifax, NS
B3L 4P1
Country [4] 260387 0
Canada

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286312 0
Research Ethics Board
Ethics committee address [1] 286312 0
Ethics committee country [1] 286312 0
Canada
Date submitted for ethics approval [1] 286312 0
09/12/2011
Approval date [1] 286312 0
Ethics approval number [1] 286312 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33517 0
Address 33517 0
Country 33517 0
Phone 33517 0
Fax 33517 0
Email 33517 0
Contact person for public queries
Name 16764 0
Claudine Szpilfogel
Address 16764 0
Research Power, Inc.
168 Ochterloney Street
Dartmouth, NS
B2Y 1E1
Country 16764 0
Canada
Phone 16764 0
(+1 (902) 405-3652
Fax 16764 0
Email 16764 0
[email protected]
Contact person for scientific queries
Name 7692 0
Dr. Michael Vallis
Address 7692 0
Capital District Health Authority
Behaviour Change Institute
7071 Bayers Rd, SUite 165
Halifax, NS
B3L 2C2
Country 7692 0
Canada
Phone 7692 0
+1 (902) 454-1611
Fax 7692 0
Email 7692 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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