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Trial registered on ANZCTR
Registration number
ACTRN12611000607976
Ethics application status
Approved
Date submitted
10/06/2011
Date registered
14/06/2011
Date last updated
12/04/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
HELP-AF: A randomised controlled trial assessing Home-based Education and Learning Program for Atrial Fibrillation
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Scientific title
In AF patients who present to the Emergency Department does the addition of a home-based learning and education package improve quality of life and reduce re-hospitalisation.
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Secondary ID [1]
262320
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Nil
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Universal Trial Number (UTN)
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Trial acronym
HELP-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
268029
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Condition category
Condition code
Cardiovascular
268158
268158
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Home-based Education and Learning Package: 2 x Home visits (1-1.5 hrs in duration). Featuring clinical characterization and delivery of information using Structured Educational Visiting techniques via a trained allied health professionals at 1-2 and 7-8 weeks after enrollment. Main education principle will be to encourage the patient to become a participant in their AF specific health care rather than a passive 'passenger'. The intervention will include printed educational material, a personal action plan, and access to advice via an emergency phone line. The action plan will be completed in collaboration with the patient's GP/cardiologist.
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Intervention code [1]
266713
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Lifestyle
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Intervention code [2]
266714
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Behaviour
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Intervention code [3]
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Treatment: Other
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Comparator / control treatment
Usual Care - Patient education is expected to be provided in an ad-hoc way depending on the needs of the patient as perceived by medical, nursing and allied hospital staff, GPs and domiciliary nursing services.
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Control group
Active
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Outcomes
Primary outcome [1]
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Total unplanned hospital admissions
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
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Assessment method [1]
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Timepoint [1]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Primary outcome [2]
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Health Related Quality of Life - SF-36 General Quality of Life questionnaire and the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
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Assessment method [2]
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Timepoint [2]
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3, 6, 12 and 24 months
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Secondary outcome [1]
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AF severity and burden score - Atrial Fibrillation Severity Scale (AFSS)
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Assessment method [1]
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Timepoint [1]
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3, 6, 12 and 24 months
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Secondary outcome [2]
276663
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Proportion of patients with >1 hospitalisation
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
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Assessment method [2]
276663
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Timepoint [2]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [3]
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Time to first hospital admission
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
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Assessment method [3]
276664
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Timepoint [3]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [4]
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Total unplanned days in hospital
Patient telephone interview cross referenced against hospital records
Medicare item number retrieval
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Assessment method [4]
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Timepoint [4]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [5]
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Total AF related hospitalisations (including Atrial Flutter) - Patients telephone interview cross referenced against medical records Medicare item number retrieval
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Assessment method [5]
276681
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Timepoint [5]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [6]
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Total cardiac hospitalisations including those related to: AF, congestive heart failure, thrombo-embolic events, bleeding events, peripheral or coronary cardiovascular events or other cardiovascular events.
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
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Assessment method [6]
276682
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Timepoint [6]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [7]
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Total non-cardiac hospitalisations
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
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Assessment method [7]
276683
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Timepoint [7]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [8]
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All-cause mortality
Medical records cross-referenced with family contact
Death certificate retrieval
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Assessment method [8]
276684
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Timepoint [8]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [9]
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Anticoagulation effectiveness
INR results from GP/specialist
Linear interpolation between time points to calculate time in theraputic range
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Assessment method [9]
276685
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Timepoint [9]
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3, 6, 9, 12, 15, 18, 21, 24 months
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Secondary outcome [10]
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Direct health service costs
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Assessment method [10]
302140
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Timepoint [10]
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24 months
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Eligibility
Key inclusion criteria
Admitted and non-admitted patients presenting to the ED with a primary reason of atrial fibrillation.
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Minimum age
30
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
Age < 30 years; Inability to provide informed consent; Home address outside hospital catchment area; Absence of ECG documentation of AF during index admission; Patients with a terminal malignancy; Patients with end stage heart failure (NYHA class IV or LVEF < 20%); Cardiac surgery < 2 months prior to index admission; Documented thyrotoxicosis or pneumonia;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of patients via a centralized web-based randomization schedule.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated variable blocked (block sizes 4-8) randomization, with stratification per hospital
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
8/04/2013
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Actual
30/04/2013
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Date of last participant enrolment
Anticipated
31/12/2015
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Actual
4/02/2016
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Date of last data collection
Anticipated
1/03/2018
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Actual
9/03/2018
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Sample size
Target
620
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Accrual to date
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Final
627
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
849
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [3]
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The Queen Elizabeth Hospital - Woodville
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Recruitment hospital [4]
1750
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Modbury Hospital - Modbury
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Recruitment hospital [5]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [6]
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Noarlunga Health Service - Noarlunga Centre
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Recruitment postcode(s) [1]
4099
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5000
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Recruitment postcode(s) [2]
4100
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5042
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Recruitment postcode(s) [3]
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5011 - Woodville
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Recruitment postcode(s) [4]
7565
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5092 - Modbury
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Recruitment postcode(s) [5]
7566
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
9284
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5168 - Noarlunga Centre
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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National Heart Foundation Cardiovascular Research Network Grant
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Address [1]
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National Heart Foundation
Level 12/500 Collins Street
MELBOURNE, VIC 3000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
The University of Adelaide
North Terrace
SA 5005
AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
266296
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Hospital
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Name [1]
266296
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Royal Adelaide Hospital
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Address [1]
266296
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Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country [1]
266296
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Australia
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Secondary sponsor category [2]
266297
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Hospital
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Name [2]
266297
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Flinders Medical Centre
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Address [2]
266297
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Flinders Medical Centre
Bedford Park
SA 5042
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Country [2]
266297
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Prof. Prashanthan Sanders
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Address [1]
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Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country [1]
252054
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Australia
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Other collaborator category [2]
252055
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Individual
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Name [2]
252055
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Dr. Kristina Jones
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Address [2]
252055
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Director of Nursing Office
Level 2, Corporate Nursing
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
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Country [2]
252055
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
252056
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A/Prof John Moss
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Address [3]
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Postgraduate Research Coordinator, School of Population Health, Mail Drop DX 650 207, THE UNIVERSITY OF ADELAIDE
Adelaide SA 5005, AUSTRALIA
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Country [3]
252056
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Australia
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Other collaborator category [4]
252057
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Individual
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Name [4]
252057
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Ms. Debra Rowett
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Address [4]
252057
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Drug and Therapeutics Information Service
Daw Park Repatriation Hospital
Daws Road
Daw Park
SA 5041
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Country [4]
252057
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Australia
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Other collaborator category [5]
252058
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Individual
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Name [5]
252058
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Dr. Anthony Brooks
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Address [5]
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Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country [5]
252058
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Australia
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Other collaborator category [6]
252059
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Individual
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Name [6]
252059
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Prof. Joseph Selvanayagam
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Address [6]
252059
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Director of Cardiac Imaging,
Flinders Medical Centre
Flinders Drive
Bedford Park
Adelaide,
SA 5042
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Country [6]
252059
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269223
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Royal Adelaide Hospital
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Ethics committee address [1]
269223
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North Terrace
Adelaide
SA 5000
Australia
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Ethics committee country [1]
269223
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Australia
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Date submitted for ethics approval [1]
269223
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30/05/2011
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Approval date [1]
269223
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15/06/2011
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Ethics approval number [1]
269223
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110609
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Ethics committee name [2]
269224
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Flinders Medical Centre
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Ethics committee address [2]
269224
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Flinders Medical Centre
Flinders Drive
Bedford Park
SA, 5042
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Ethics committee country [2]
269224
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Australia
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Date submitted for ethics approval [2]
269224
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23/05/2011
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Approval date [2]
269224
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22/08/2011
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Ethics approval number [2]
269224
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260.11
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Ethics committee name [3]
269225
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University of Adelaide
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Ethics committee address [3]
269225
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The University of Adelaide
North Terrace
SA 5005
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Ethics committee country [3]
269225
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Australia
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Date submitted for ethics approval [3]
269225
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15/06/2011
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Approval date [3]
269225
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15/06/2011
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Ethics approval number [3]
269225
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RAH_110609
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Ethics committee name [4]
269226
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Department of Health and Ageing / Medicare
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Ethics committee address [4]
269226
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Departmental Ethics Committee
Australian Government Department of Health and Ageing
MDP 132
GPO Box 9848
Canberra ACT 2601
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Ethics committee country [4]
269226
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Australia
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Date submitted for ethics approval [4]
269226
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13/07/2011
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Approval date [4]
269226
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24/02/2012
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Ethics approval number [4]
269226
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17/2011
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Ethics committee name [5]
288274
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DVA Human Research Ethics Committee
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Ethics committee address [5]
288274
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13 Keltie St Phillip ACT 2006
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Ethics committee country [5]
288274
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Australia
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Date submitted for ethics approval [5]
288274
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03/02/2012
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Approval date [5]
288274
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09/03/2012
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Ethics approval number [5]
288274
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E011/003 (4.1)
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Summary
Brief summary
Atrial fibrillation (AF) is the most common abnormal heart rhythm in the population and its prevalence is rapidly increasing. Sufferers of atrial fibrillation have a significantly impaired quality of life and their medical management is placing a growing burden on the Australian health care system. The proposed study will examine whether a home-based education program, will reduce hospital use and improve quality of life in AF patients compared to those patients who experience usual medical care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Prashanthan Sanders
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Address
32704
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Centre for Heart Rhythm Disorders, Level 5 McEwin Building Royal Adelaide Hospital North Terrace Adelaide SA. 5000
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Country
32704
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Australia
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Phone
32704
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+61 8 8222 2723
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Fax
32704
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+61 8 8222 2722
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Email
32704
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[email protected]
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Contact person for public queries
Name
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Prof Prashanthan Sanders
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Address
15951
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Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
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Country
15951
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Australia
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Phone
15951
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+61 8 8222 2723
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Fax
15951
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+61 8 8222 2722
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Email
15951
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[email protected]
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Contact person for scientific queries
Name
6879
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Prof Prashanthan Sanders
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Address
6879
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Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
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Country
6879
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Australia
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Phone
6879
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+61882222723
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Fax
6879
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+61 8 8222 2722
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Email
6879
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Integrated Care in Atrial Fibrillation: A Road Map to the Future.
2021
https://dx.doi.org/10.1161/CIRCOUTCOMES.120.007411
Embase
Home-Based Education and Learning Program for Atrial Fibrillation: Rationale and Design of the HELP-AF Study.
2019
https://dx.doi.org/10.1016/j.cjca.2019.03.020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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