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Trial registered on ANZCTR


Trial ID
ACTRN12613000750785
Ethics application status
Approved
Date submitted
13/06/2013
Date registered
5/07/2013
Date last updated
5/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Choice of Health Options in Prevention of Cardiovascular Events - Atrial Fibrillation (CHOICE-AF) pilot study
Scientific title
Choice of Health Options in Prevention of Cardiovascular Events-Atrial Fibrillation (CHOICE-AF) - in patients with atrial fibrillation, does a patient-centred intervention targeting individualised risk factor management (in addition to standard medical care) improve risk factors compared to before the intervention?
Secondary ID [1] 282620 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHOICE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 289311 0
Stroke 289312 0
Condition category
Condition code
Cardiovascular 289648 289648 0 0
Other cardiovascular diseases
Stroke 289649 289649 0 0
Ischaemic
Public Health 289650 289650 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot study is proposed with 20 participants, using a prepost design, to determine the format required for a risk
factor management program. Participants will receive a patient-centred intervention targeting individualised risk factor management of 3 months duration with 3 month followup, including a community-based physical activity program, in addition to standard medical care. The program is based on health coaching principles.

The patient-centred intervention targeting individualised risk factor management involves a 1 hour face-to-face goal setting meeting at baseline. Ongoing support is provided throughout the trial by regular telephone calls from the intervention nurse. Patients will receive a mean of 4 calls (for about 10-20 minutes each) throughout the 3 month intervention period, depending on need. Motivational interviewing techniques will be used. Motivational interviewing, as described by Miller and Rollnick, is a method that works on facilitating and engaging intrinsic motivation within the client in order to change behaviour. The approach is non-judgmental, non-confrontational and non-adversarial.

The community-based physical activity program depends on what is available in a participant's local community, e.g. could be a walking group. The number of sessions involved will depend on the goals set by each individual participant, e.g. they may select to walk for 20 minutes 5 times per week.

Standard medical care involves a consultations with a GP, cardiologist or consultant. This is not determined by the study, and participants will continue to be treated by their doctors.

Strategies used to improve adherence to the intervention protocols include the validated Morisky self-report; community pharmacy dispensed history print-out; and INR time in therapeutic range.
Intervention code [1] 287286 0
Prevention
Intervention code [2] 287471 0
Lifestyle
Comparator / control treatment
Pre-post design, there is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289729 0
Change in body mass, assessed by weighing participants on bathroom scales.
Timepoint [1] 289729 0
Three months after a participant's baseline assessment.
Secondary outcome [1] 303115 0
Measures of other cardiovascular risk factors, including physical activity, heart rate and rhythm, smoking status, blood pressure, diet / alcohol, diabetic control and lipid profile.

Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ); heart rate and rhythm will be measured using a 12 lead electrocardiograph (ECG) and radial pulse; smoking status will be assessed using a carbon monoxide meter (smokerlyser); blood pressure will be measured with a supported right arm, participant seated using a calibrated digital sphygmomanometer and appropriate sized cuff; diabetic control will be assessed using fasting glucose and HbA1c measured by fasting blood sample; lipid profile will be assessed by total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides measured by fasting blood sample.
Timepoint [1] 303115 0
Three months after each participant's baseline assessment.
Secondary outcome [2] 303116 0
Participants' psychosocial wellbeing.
This will be measured with the following validated tools: the Hospital Anxiety and Depression Scale (HADS), the SF-12 health survey and AFEQT questionnaire.
Timepoint [2] 303116 0
Three months after each patient's baseline assessment.
Secondary outcome [3] 303117 0
Unplanned hospital readmission for a cardiovascular reason or event. This will be assessed by monitoring hospital admission records.
Timepoint [3] 303117 0
For the 3 month duration of the pilot study.
Secondary outcome [4] 303257 0
Patients' adherence to medication. This will be assessed using the validated Morisky self-report tool; community pharmacy dispensed history print-out; and INR time in therapeutic range.
Timepoint [4] 303257 0
Three months after each patient's baseline assessment.

Eligibility
Key inclusion criteria
Patients will be eligible to participate if they have presented to hospital with atrial fibrillation within the previous six months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: clinical diagnosis of uncompensated cardiac failure (Class III or IV); uncontrolled arrhythmia or angina; severe or symptomatic aortic stenosis; uncontrolled hypotension/hypertension; diagnosis of a severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting the inclusion and exclusion criteria will be approached by the hospital cardiac rehabilitation (CR) co-ordinator or CHOICE-AF research assistant, during their inpatient stay where-ever possible, or via letter or telephone soon after hospital discharge. The participant’s cardiologist will be approached prior to initial interview to ensure appropriateness for inclusion in the study.
No allocation concealment procedures are required for this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary analyses will be conducted by intention-to-treat using SPSS for Windows (Version 17.0) and will be presented as mean and standard error of the mean or proportions. Differences in outcome measures, between and within groups, will be compared using repeated measures ANOVAs for continuous variables and either chi-square tests or Fishers exact tests, as appropriate, for proportions of categorical variables. Two tailed p values of less than 0.05 will be considered significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287397 0
University
Name [1] 287397 0
University of Sydney / ANZAC Research Institute
Address [1] 287397 0
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
Country [1] 287397 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 286138 0
University
Name [1] 286138 0
University of Sydney
Address [1] 286138 0
University of Sydney NSW 2006
Country [1] 286138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289374 0
Sydney Local Health District Human Research Ethics Committee - CRGH
Ethics committee address [1] 289374 0
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Ethics committee country [1] 289374 0
Australia
Date submitted for ethics approval [1] 289374 0
26/08/2011
Approval date [1] 289374 0
16/11/2011
Ethics approval number [1] 289374 0
HREC/11/CRGH/207
Ethics committee name [2] 289375 0
University of Sydney Human Research Ethics Committee
Ethics committee address [2] 289375 0
University of Sydney
NSW 2006
Ethics committee country [2] 289375 0
Australia
Date submitted for ethics approval [2] 289375 0
Approval date [2] 289375 0
04/05/2012
Ethics approval number [2] 289375 0
Protocol No. 14821

Summary
Brief summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting one in four people in the adult population. AF is a major cause of admission to hospital and represents a major public health burden. AF is an independent risk factor for stroke, with a near five fold excess of stroke observed in patients with AF. It is of even greater concern that patients living with AF experience a range of physical and psychological symptoms which are distressing and impact negatively on their quality of life. In addition, those with AF have a high prevalence of known cardiovascular risk factors such as being physically inactive, overweight and having hypertension.

Despite the evidence that cardiovascular risk factors are poorly controlled in patients with AF, they are typically not included in risk factor reduction programmes. Therefore, in this study, we aim to determine if a simple patient-centred, home-based risk factor management program can improve cardiovascular risk and quality of life in patients with clinically diagnosed AF.

The study will be a pilot trial using a pre-post design with 3 month follow-up of clinical outcomes involving 20 people with AF. A mixed methods design comprising both quantitative and qualitative methods will be utilised.
Study volunteers will have a baseline assessment and an initial in-person module selection and goal-setting session of approximately one hour. All participants will take part in a 3-month patient-centred intervention with tailored risk factor management and an individually tailored community-based exercise program. This program is based on health coaching and motivational interviewing principles and the extensive experience the researchers have with modular secondary prevention of cardiovascular disease and behaviour modification in high risk patients. Simultaneous, ongoing consultation with their general practitioner and specialist physician will be encouraged as part of standard medical care.

Outcome assessments for all participants in the pilot study will be made at three months after baseline assessment.
Trial website
Trial related presentations / publications
Public notes
Please note, the old name for this study (used in the original ethics application approved on 16/11/2011) was the Health Education Lifestyle and Pharmacotherapy in Atrial Fibrillation (HELP-AF) pilot study.

Contacts
Principal investigator
Name 40530 0
Prof Ben Freedman
Address 40530 0
Cardiology Department
Concord Repatriation General Hospital
Hospital Road Concord NSW 2139
Country 40530 0
Australia
Phone 40530 0
+61-2-9767-7358
Fax 40530 0
Email 40530 0
ben.freedman@sydney.edu.au
Contact person for public queries
Name 40531 0
Dr Lis Neubeck
Address 40531 0
The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060
Country 40531 0
Australia
Phone 40531 0
+61 2 8507 2521
Fax 40531 0
Email 40531 0
lneubeck@georgeinstitute.org.au
Contact person for scientific queries
Name 40532 0
Dr Lis Neubeck
Address 40532 0
The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060
Country 40532 0
Australia
Phone 40532 0
+61 2 8507 2521
Fax 40532 0
Email 40532 0
lneubeck@georgeinstitute.org.au