Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001249448
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
7/09/2016
Date last updated
13/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Current management of lifestyle related risk factors in atrial fibrillation
Scientific title
Cardiovascular risk factor management in atrial fibrillation
Secondary ID [1] 289723 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FACT-AF
Linked study record
Home Based Education and Learning Program in Atrial Fibrillation - HELP-AF study. ACTRN12611000607976.

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 299560 0
Condition category
Condition code
Cardiovascular 299531 299531 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
The aim of this project is to characterise how cardiovascular risk factors are currently managed in a cohort of patients who have presented to an emergency department with symptomatic AF. Participants will be recruited from an existing research study (the Home Based Education and Learning Program in Atrial Fibrillation - HELP-AF - ACTRN12611000607976). The HELP-AF study is examining the impact of home based education package delivered by a nurse or pharmacist to participants who have presented to the emergency department, primarily due to atrial fibrillation. On completion of the HELP-AF study, participants will be invited to participate in this study. Participants will undergo a series of investigations including physical assessment, echocardiogram, holter monitor, blood sampling and exercise stress testing on one occasion. Each assessment is expected to take approximately 2 hours. Participants will also complete a number of questionnaires to evaluate quality of life, AF symptom burden and knowledge of their condition.These questionnaires will be completed at baseline, six and twelve months post the risk factor assessment. At six and twelve months post baseline risk factor assessment, participants will be contacted by telephone to determine how many occasions they have visited their GP, Cardiologist or been admitted to hospital. Reasons for hospital admission will be ascertained by patient self report (AF related, cardiac related, all cause) and confirmed by an electronic health record where possible.
Intervention code [1] 295359 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299012 0
Proportion of patients meeting cardiovascular risk factor targets as outlined in the 'Australian absolute cardiovascular risk guidelines'. This will be assessed via a questionnaire designed for this study and by blood sampling. Recommended risk factor targets for blood pressure, lipid profile, smoking status, physical activity, HbA1c (in diabetic patients) and glucose levels will be compared against participant results.
Timepoint [1] 299012 0
Baseline assessment
Secondary outcome [1] 325862 0
To determine factors associated with a good overall cardiovascular risk factor status. Factors to be examined include age, postcode, level of education, knowledge score (as assessed by the Atrial Fibrillation Knowledge Scale which participants complete on exit from the HELP-AF study), co-existent ischaemic heart disease or heart failure, education received during the HELP-AF study vs usual care participants and regular Cardiologist reviews. This information will be collected by a questionnaire designed for this study.
Timepoint [1] 325862 0
Following baseline assessment of all participants
Secondary outcome [2] 325863 0
To determine if there is any association between cardiovascular risk factor status and health care resource utilisation. Risk factor status will be assessed by a questionnaire designed for this study and by investigations including blood sampling, echocardiography to examine cardiac structure and exercise stress testing to determine exercise capacity. Health care resource utilisation will be examined by patient self report at telephone follow up at six and 12 months post study enrolment. Participants will be asked how many occasions they have visited their General Practitioner (GP), Cardiologist and reasons for admission to hospital (this will be cross checked by electronic health record where possible).
Timepoint [2] 325863 0
Baseline, six and twelve months post study enrolment.
Secondary outcome [3] 327499 0
To determine any association between participant knowledge of their condition and health care resource utilisation. Participant knowledge be assessed by a knowledge questionnaire which has been developed for the HELP-AF study and health care resource utilisation will be assessed by patient self report at six and twelve months post enrolment in to the study, cross checked with an electronic health record where possible.
Timepoint [3] 327499 0
Baseline, six and twelve months post study enrolment.
Secondary outcome [4] 327500 0
To determine if any association exists between AF disease burden and health care resource utilisation. Disease burden will be assessed by a holter monitor undertaken at study entry. Health care resource utilisation will be assessed by telephone call at six and twelve months post study enrolment where participants will be asked how many times they have visited their GP and Cardiologist. They will also be asked how many times they have been admitted to hospital and reasons for admission. This will be cross checked by electronic health record where possible.
Timepoint [4] 327500 0
Baseline, six and twelve months post study enrolment.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Presented to ED primarily due to symptoms from AF
2.. capable of providing informed consent
3. completed follow up of the HELP-AF study within previous 12 months
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Age <30 years
2.. Absence of ECG documentation of AF during index presentation
3.. Patients with end stage heart failure (NYHA class IV, LVEF <20%)
4.. Cardiac surgery less than 2 months prior to index presentation
5. Patients with a recent history (<1 year) of, or current malignancy, undergoing
chemotherapy or radiotherapy
6. documented thyrotoxicosis at time of index presentation
7. pneumonia at time of index presentation
8. poor English literacy
9.. non independent living.
10..any terminal illness or serious medical condition e.g. terminal cancer, end stage heart
failure or renal failure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be analysed as proportion of participants meeting guideline recommendation for cardiovascular risk factor targets. The impact of education received as part of the HELP-AF study on cardiovascular risk factor status will be examined. Additionally, associations between patient knowledge of their condition, cardiovascular risk factor status and health care resource utilisation will also be examined. As this is not an interventional study, sample size calculations have not been performed. The aim of this study is to characterise how cardiovascular risk factors are currently managed in a contemporary cohort of participants with AF with a proposed recruitment number of 300 identified as the number of participants in the HELP-AF study who may be willing to participate in this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2016
Actual
8/09/2016
Date of last participant enrolment
Anticipated
5/02/2019
Actual
Date of last data collection
Anticipated
4/02/2019
Actual
Sample size
Target
300
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294102 0
University
Name [1] 294102 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 294102 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
Royal Adelaide Hospital
c/- CVIU, Level 6, Theatre Block
North Terrace
ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 292938 0
None
Name [1] 292938 0
Address [1] 292938 0
Country [1] 292938 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295519 0
Royal Adelaide Hospital
Ethics committee address [1] 295519 0
Ethics committee country [1] 295519 0
Australia
Date submitted for ethics approval [1] 295519 0
Approval date [1] 295519 0
12/05/2016
Ethics approval number [1] 295519 0
HREC/16/RAH/99

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67586 0
Prof Prashanthan Sanders
Address 67586 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Royal Adelaide Hospital
CVIU, Level 6, Theatre Block
North Terrace
ADELAIDE SA 5000
Country 67586 0
Australia
Phone 67586 0
+61 8 8222 2723
Fax 67586 0
+61 8 8222 2722
Email 67586 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 67587 0
Celine Gallagher
Address 67587 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Royal Adelaide Hospital
CVIU, Level 6, Theatre Block
North Terrace
ADELAIDE SA 5000
Country 67587 0
Australia
Phone 67587 0
+61 8 8222 2723
Fax 67587 0
+61 8 8222 2722
Email 67587 0
celine.gallagher@adelaide.edu.au
Contact person for scientific queries
Name 67588 0
Celine Gallagher
Address 67588 0
Centre for Heart Rhythm Disorders
University of Adelaide
c/- Royal Adelaide Hospital
CVIU, Level 6, Theatre Block
North Terrace
ADELAIDE SA 5000
Country 67588 0
Australia
Phone 67588 0
+61 8 8222 2723
Fax 67588 0
+61 8 8222 2722
Email 67588 0
celine.gallagher@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
No additional documents have been identified.