None listed
Conditions
Brief summary
The purpose of this trial is to understand the differences between a disease management program incorporating better risk identification and management, and atrial fibrillation-specific components of treatment designed to specifically improve health outcomes in patients with chronic, non-valvular forms of atrial fibrillation. Given that this represents an increasing patient population subject to complex treatment, it has the potential to deliver significant clinical benefits from an individual to a health care system perspective. Therefore, SAFETY will test the hypothesis that in patients with chronic, non-valvular forms of atrial fibrillation, a specific program of enhanced risk identification and management (above conventional risk profiling) combined with an atrial fibrillation-specific form of chronic disease management will significantly reduce all-cause death and/or unplanned hospital readmission relative to standard medical care during a follow-up of 24 months.
Interventions
Atrial fibrillation-specific disease management programme involving improved understanding and delineation of a patient's underlying risk of thrombo-embolic events, progressive cardiac dysfunction and poorly controlled clinical status. This will be done via evaluation of haemodynamic and embolic risk and the optimisation of a patient's psychosocial adaptation to the requirements of pharmacotherapy for atrial fibrillation involving home visitation.
The approximately 2 hour home visit will be perf
Atrial fibrillation-specific disease management programme involving improved understanding and delineation of a patient's underlying risk of thrombo-embolic events, progressive cardiac dysfunction and poorly controlled clinical status. This will be done via evaluation of haemodynamic and embolic risk and the optimisation of a patient's psychosocial adaptation to the requirements of pharmacotherapy for atrial fibrillation involving home visitation. The approximately 2 hour home visit will be performed by a cardiac research nurse and will occur 7-14 days post-hospital discharge. The nurse will identify and address any areas that require improvement for the improvement of the patient's health status and well-being and reduction of cardiovascular risk factors (e.g. suggestion of a weight-loss intervention if the patient is overweight). In addition, due to the heart rate focussed nature of atrial fibrillation, the nurse will visit the patient for approximately 30 minutes at 1 month, 3 months and 6 months to make sure that they are within their target heart rate that has been set by their physician. If not, the nurse will instigate action required to rectify this via lifestyle or pharmacological means. At 12 months and 24 months, patients will have an approximately 2 hour, one-on-one clinic visit with a member of the research team to undergo and compare with baseline measurements, the following: their physical health, any medical issues that have arisen in the follow-up period, the electrical activity of the heart (using an electrocardiogram - ECG), how the heart is pumping (via echocardiography), their general clinical status (via pathology testing), the clinical status of their atrial fibrillation, their cognitive and functional capacity, and their mental health and well-being. A 24 hour continuous recording of the electrical activity of the heart that will be taken at baseline and 12 months via a Holter Monitor (which will be fitted by the cardiac nurse) will also be performed. In summary, these patients will be followed-up for a period of 24 months and the above measurements will be taken.
Sponsors
Baker IDI Heart & Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented diagnosis of sustained form of non-valvular atrial fibrillation 2. A minimum of one hospitalisation (including index admission) related, at least in part, to atrial fibrillation 3. Are living independently in the community or their own home post-hospitalisation 4. Are able and willing to provide written informed consent to participate in the trial
Exclusion criteria
1. Aged below 45 years 2. Have a diagnosis of valvular atrial fibrillation 3. Are scheduled for a catheter ablation for treatment of atrial fibrillation 4. Have evidence of pre-existing New York Heart Association (NYHA) Class III-IV with a documented left ventricular ejection fraction less than 45% 5. Have alcohol-induced atrial fibrillation 6. Have transient forms of atrial fibrillation associated with acute myocardial infarction and/or pericarditis 7. Have a terminal condition or malignancy requiring palliative care 8. Cannot adequately provide written informed consent to participate 9. Have any other medical condition that results in the belief that it is not appropriate for the patient to embark on participation within this study
Outcome results
None listed