Trial Review

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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
Sex
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
8/04/2013
Actual
30/04/2013
Date of last participant enrolment
Anticipated
31/12/2015
Actual
4/02/2016
Date of last data collection
Anticipated
1/03/2018
Actual
9/03/2018
Sample size
Target
620
Accrual to date
Final
627
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
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
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
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
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
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
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
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
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
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


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
SourceTitleYear of PublicationDOI
EmbaseHome-Based Education and Learning Program for Atrial Fibrillation: Rationale and Design of the HELP-AF Study.2019https://dx.doi.org/10.1016/j.cjca.2019.03.020
EmbaseIntegrated Care in Atrial Fibrillation: A Road Map to the Future.2021https://dx.doi.org/10.1161/CIRCOUTCOMES.120.007411
N.B. These documents automatically identified may not have been verified by the study sponsor.