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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 information initially 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
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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?
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Secondary ID [1]
282620
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Nil
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Universal Trial Number (UTN)
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Trial acronym
CHOICE-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation
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Stroke
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Condition category
Condition code
Cardiovascular
289648
289648
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0
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Other cardiovascular diseases
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Stroke
289649
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0
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Ischaemic
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Public Health
289650
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287286
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Prevention
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Intervention code [2]
287471
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Lifestyle
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Comparator / control treatment
Pre-post design, there is no control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in body mass, assessed by weighing participants on bathroom scales.
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Assessment method [1]
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Timepoint [1]
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Three months after a participant's baseline assessment.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Three months after each participant's baseline assessment.
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Three months after each patient's baseline assessment.
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Secondary outcome [3]
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Unplanned hospital readmission for a cardiovascular reason or event. This will be assessed by monitoring hospital admission records.
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Assessment method [3]
303117
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Timepoint [3]
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For the 3 month duration of the pilot study.
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Secondary outcome [4]
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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.
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Assessment method [4]
303257
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Timepoint [4]
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Three months after each patient's baseline assessment.
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Eligibility
Key inclusion criteria
Patients will be eligible to participate if they have presented to hospital with atrial fibrillation within the previous six months.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Pre-post design
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/11/2012
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Actual
5/11/2012
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Date of last participant enrolment
Anticipated
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Actual
18/03/2013
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Date of last data collection
Anticipated
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Actual
30/06/2016
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Sample size
Target
20
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Sydney / ANZAC Research Institute
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Address [1]
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Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Concord Repatriation General Hospital
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Address
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Sydney
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Address [1]
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University of Sydney NSW 2006
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Country [1]
286138
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289374
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Sydney Local Health District Human Research Ethics Committee - CRGH
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Ethics committee address [1]
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Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/08/2011
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Approval date [1]
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16/11/2011
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Ethics approval number [1]
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HREC/11/CRGH/207
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Ethics committee name [2]
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University of Sydney Human Research Ethics Committee
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Ethics committee address [2]
289375
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University of Sydney
NSW 2006
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Ethics committee country [2]
289375
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Australia
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Date submitted for ethics approval [2]
289375
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Approval date [2]
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04/05/2012
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Ethics approval number [2]
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Protocol No. 14821
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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.
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Trial website
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Trial related presentations / publications
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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.
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Contacts
Principal investigator
Name
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Prof Ben Freedman
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Address
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Cardiology Department
Concord Repatriation General Hospital
Hospital Road Concord NSW 2139
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Country
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Australia
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Phone
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+61-2-9767-7358
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Lis Neubeck
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Address
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The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060
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Country
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Australia
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Phone
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+61 2 8507 2521
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Fax
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Query!
Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Lis Neubeck
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Address
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The George Institute for Global Health
83-117 Missenden Rd
Camperdown NSW 2060
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Country
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Australia
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Phone
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+61 2 8507 2521
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Lowres N, Redfern J, Freedman SB, et al. Choice of...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
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
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
N.B. These documents automatically identified may not have been verified by the study sponsor.
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