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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
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.
Secondary ID [1] 262320 0
Nil
Universal Trial Number (UTN)
Trial acronym
HELP-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 268029 0
Condition category
Condition code
Cardiovascular 268158 268158 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 266713 0
Lifestyle
Intervention code [2] 266714 0
Behaviour
Intervention code [3] 266750 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 266937 0
Total unplanned hospital admissions
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
Timepoint [1] 266937 0
3, 6, 9, 12, 15, 18, 21, 24 months
Primary outcome [2] 266938 0
Health Related Quality of Life - SF-36 General Quality of Life questionnaire and the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Timepoint [2] 266938 0
3, 6, 12 and 24 months
Secondary outcome [1] 276662 0
AF severity and burden score - Atrial Fibrillation Severity Scale (AFSS)
Timepoint [1] 276662 0
3, 6, 12 and 24 months
Secondary outcome [2] 276663 0
Proportion of patients with >1 hospitalisation
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
Timepoint [2] 276663 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [3] 276664 0
Time to first hospital admission
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
Timepoint [3] 276664 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [4] 276665 0
Total unplanned days in hospital
Patient telephone interview cross referenced against hospital records
Medicare item number retrieval
Timepoint [4] 276665 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [5] 276681 0
Total AF related hospitalisations (including Atrial Flutter) - Patients telephone interview cross referenced against medical records Medicare item number retrieval
Timepoint [5] 276681 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [6] 276682 0
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
Timepoint [6] 276682 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [7] 276683 0
Total non-cardiac hospitalisations
Patient telephone interview cross referenced against medical records
Medicare item number retrieval
Timepoint [7] 276683 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [8] 276684 0
All-cause mortality
Medical records cross-referenced with family contact
Death certificate retrieval
Timepoint [8] 276684 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [9] 276685 0
Anticoagulation effectiveness
INR results from GP/specialist
Linear interpolation between time points to calculate time in theraputic range
Timepoint [9] 276685 0
3, 6, 9, 12, 15, 18, 21, 24 months
Secondary outcome [10] 302140 0
Direct health service costs
Timepoint [10] 302140 0
24 months

Eligibility
Key inclusion criteria
Admitted and non-admitted patients presenting to the ED with a primary reason of atrial fibrillation.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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;

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)
Allocation of patients via a centralized web-based randomization schedule.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
SA
Recruitment hospital [1] 848 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 849 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 1749 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 1750 0
Modbury Hospital - Modbury
Recruitment hospital [5] 1751 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 3520 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 4099 0
5000
Recruitment postcode(s) [2] 4100 0
5042
Recruitment postcode(s) [3] 7564 0
5011 - Woodville
Recruitment postcode(s) [4] 7565 0
5092 - Modbury
Recruitment postcode(s) [5] 7566 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 9284 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 267232 0
Charities/Societies/Foundations
Name [1] 267232 0
National Heart Foundation Cardiovascular Research Network Grant
Address [1] 267232 0
National Heart Foundation
Level 12/500 Collins Street
MELBOURNE, VIC 3000
Country [1] 267232 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
The University of Adelaide
North Terrace
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 266296 0
Hospital
Name [1] 266296 0
Royal Adelaide Hospital
Address [1] 266296 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 266296 0
Australia
Secondary sponsor category [2] 266297 0
Hospital
Name [2] 266297 0
Flinders Medical Centre
Address [2] 266297 0
Flinders Medical Centre
Bedford Park
SA 5042
Country [2] 266297 0
Australia
Other collaborator category [1] 252054 0
Individual
Name [1] 252054 0
Prof. Prashanthan Sanders
Address [1] 252054 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 252054 0
Australia
Other collaborator category [2] 252055 0
Individual
Name [2] 252055 0
Dr. Kristina Jones
Address [2] 252055 0
Director of Nursing Office
Level 2, Corporate Nursing
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country [2] 252055 0
Australia
Other collaborator category [3] 252056 0
Individual
Name [3] 252056 0
A/Prof John Moss
Address [3] 252056 0
Postgraduate Research Coordinator, School of Population Health, Mail Drop DX 650 207, THE UNIVERSITY OF ADELAIDE
Adelaide SA 5005, AUSTRALIA
Country [3] 252056 0
Australia
Other collaborator category [4] 252057 0
Individual
Name [4] 252057 0
Ms. Debra Rowett
Address [4] 252057 0
Drug and Therapeutics Information Service
Daw Park Repatriation Hospital
Daws Road
Daw Park
SA 5041
Country [4] 252057 0
Australia
Other collaborator category [5] 252058 0
Individual
Name [5] 252058 0
Dr. Anthony Brooks
Address [5] 252058 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [5] 252058 0
Australia
Other collaborator category [6] 252059 0
Individual
Name [6] 252059 0
Prof. Joseph Selvanayagam
Address [6] 252059 0
Director of Cardiac Imaging,
Flinders Medical Centre
Flinders Drive
Bedford Park
Adelaide,
SA 5042
Country [6] 252059 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269223 0
Royal Adelaide Hospital
Ethics committee address [1] 269223 0
North Terrace
Adelaide
SA 5000
Australia
Ethics committee country [1] 269223 0
Australia
Date submitted for ethics approval [1] 269223 0
30/05/2011
Approval date [1] 269223 0
15/06/2011
Ethics approval number [1] 269223 0
110609
Ethics committee name [2] 269224 0
Flinders Medical Centre
Ethics committee address [2] 269224 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA, 5042
Ethics committee country [2] 269224 0
Australia
Date submitted for ethics approval [2] 269224 0
23/05/2011
Approval date [2] 269224 0
22/08/2011
Ethics approval number [2] 269224 0
260.11
Ethics committee name [3] 269225 0
University of Adelaide
Ethics committee address [3] 269225 0
The University of Adelaide
North Terrace
SA 5005
Ethics committee country [3] 269225 0
Australia
Date submitted for ethics approval [3] 269225 0
15/06/2011
Approval date [3] 269225 0
15/06/2011
Ethics approval number [3] 269225 0
RAH_110609
Ethics committee name [4] 269226 0
Department of Health and Ageing / Medicare
Ethics committee address [4] 269226 0
Departmental Ethics Committee
Australian Government Department of Health and Ageing
MDP 132
GPO Box 9848
Canberra ACT 2601
Ethics committee country [4] 269226 0
Australia
Date submitted for ethics approval [4] 269226 0
13/07/2011
Approval date [4] 269226 0
24/02/2012
Ethics approval number [4] 269226 0
17/2011
Ethics committee name [5] 288274 0
DVA Human Research Ethics Committee
Ethics committee address [5] 288274 0
13 Keltie St Phillip ACT 2006
Ethics committee country [5] 288274 0
Australia
Date submitted for ethics approval [5] 288274 0
03/02/2012
Approval date [5] 288274 0
09/03/2012
Ethics approval number [5] 288274 0
E011/003 (4.1)

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32704 0
Prof Prashanthan Sanders
Address 32704 0
Centre for Heart Rhythm Disorders, Level 5 McEwin Building Royal Adelaide Hospital North Terrace Adelaide SA. 5000
Country 32704 0
Australia
Phone 32704 0
+61 8 8222 2723
Fax 32704 0
+61 8 8222 2722
Email 32704 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 15951 0
Prof Prashanthan Sanders
Address 15951 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
Country 15951 0
Australia
Phone 15951 0
+61 8 8222 2723
Fax 15951 0
+61 8 8222 2722
Email 15951 0
prash.sanders@adelaide.edu.au
Contact person for scientific queries
Name 6879 0
Prof Prashanthan Sanders
Address 6879 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
Country 6879 0
Australia
Phone 6879 0
+61882222723
Fax 6879 0
+61 8 8222 2722
Email 6879 0
prash.sanders@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary