ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000750785

Ethics application status

Approved

Date submitted

13/06/2013

Date registered

5/07/2013

Date last updated

7/12/2020

Date data sharing statement initially provided

7/12/2020

Date results provided

7/12/2020

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]

Nil

Universal Trial Number (UTN)

Trial acronym

CHOICE-AF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial fibrillation

Stroke

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Stroke

Ischaemic

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

Pre-post design, there is no control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in body mass, assessed by weighing participants on bathroom scales.

Timepoint [1]

Three months after a participant's baseline assessment.

Secondary outcome [1]

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]

Three months after each participant's baseline assessment.

Secondary outcome [2]

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]

Three months after each patient's baseline assessment.

Secondary outcome [3]

Unplanned hospital readmission for a cardiovascular reason or event. This will be assessed by monitoring hospital admission records.

Timepoint [3]

For the 3 month duration of the pilot study.

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

5/11/2012

Actual

5/11/2012

Date of last participant enrolment

Anticipated

Actual

18/03/2013

Date of last data collection

Anticipated

Actual

30/06/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney / ANZAC Research Institute

Address [1]

Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139

Country [1]

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]

University

Name [1]

University of Sydney

Address [1]

University of Sydney NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee - CRGH

Ethics committee address [1]

Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/08/2011

Approval date [1]

16/11/2011

Ethics approval number [1]

HREC/11/CRGH/207

Ethics committee name [2]

University of Sydney Human Research Ethics Committee

Ethics committee address [2]

University of Sydney
NSW 2006

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

04/05/2012

Ethics approval number [2]

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

Prof Ben Freedman

Address

Cardiology Department
Concord Repatriation General Hospital
Hospital Road Concord NSW 2139

Country

Australia

Phone

+61-2-9767-7358

Fax

ben.freedman@sydney.edu.au

Contact person for public queries

Name

Lis Neubeck

Address

The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060

Country

Australia

Phone

+61 2 8507 2521

Fax

lneubeck@georgeinstitute.org.au

Contact person for scientific queries

Name

Lis Neubeck

Address

The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060

Country

Australia

Phone

+61 2 8507 2521

Fax

lneubeck@georgeinstitute.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Choice of Health Options in prevention of Cardiovascular Events for people with Atrial Fibrillation (CHOICE-AF): A pilot study.	2016	https://dx.doi.org/10.1177/1474515114549687
Embase	Using the 'Think Aloud' Technique to Explore Quality of Life Issues During Standard Quality-of-Life Questionnaires in Patients With Atrial Fibrillation.	2017	https://dx.doi.org/10.1016/j.hlc.2016.05.121

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically