ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001109493

Ethics application status

Approved

Date submitted

8/08/2016

Date registered

16/08/2016

Date last updated

9/02/2022

Date data sharing statement initially provided

14/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Integrated Care for Atrial Fibrillation Management: A Randomised Controlled Trial

Scientific title

Effectiveness of Integrated Care Management for Atrial Fibrillation on all-cause hospitalisation and mortality: A Randomised Controlled Trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

iCARE-AF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Cardiovascular Risk Factors

Condition category

Condition code

Diet and Nutrition

Obesity

Cardiovascular

Other cardiovascular diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a multi-centre, prospective, randomised controlled study, evaluating the effect of integrated specialised clinics for patients with atrial fibrillation (AF). The specialised AF clinics include structured AF management and aggressive risk factor management.

The study population comprises adults with AF presenting to the emergency department or cardiology outpatient department. Participants in the active (intervention) group undergo protocolised clinical investigation, including an echocardiogram, 24-hour Holter monitoring or treadmill (to assess rate control), laboratory testing (thyroid function and cardiovascular profile) and ECG, before visiting the specialised AF outpatient clinic (iCARE-AF clinic). The treatment team includes e.g., cardiologists, electrophysiologists, general practitioners, specialist nurses, and pharmacists, providing integrated and comprehensive management. The specialist nurse is the case manager and care coordinator. The intervention period for each participant is two years from the date of enrolment.

Participants in the intervention group attend 3-monthly consultations (30-45 minutes) in the first year. During these consultations, the specialist nurse will record the participant’s medical history and screen for cardiovascular (CV) risk factors. The nurse provides structured education, tailored to the individual’s abilities and needs, incorporating the cardiac condition, possible complications, and diagnostic test results. This will support treatment options and risk factor management.

During the intervention, the care provider uses decision-support software for comprehensive AF and CV risk management. The software serves as an electronic checklist to prevent incomplete diagnostic and therapeutic guideline-adherent AF and CV risk management and can be used to support the participant’s educational goals. The software is designed as a tool to assist both care provider and study participant to provide tailored care and education, which requires participant input during consultations. This system helps to navigate and support decision-making for the treatment team throughout the integrated care process.

CV risk factor management will be performed using an approach that has been successfully used in a prior study from our group and was assessed and approved by the Royal Adelaide Hospital HREC. This includes the following elements:

WEIGHT LOSS management will be approached using structured, multidisciplinary, motivational, and goal-directed face-to-face visits every 3 months in the first year, and every 6 months thereafter for study participants with a BMI of equal to or greater than 27kg/m2. Nutritional behaviour reflection, barriers to goal achievement and nutritional decision coaching will be addressed in the 20-40-minute counselling sessions. Verbal and written tailored education materials will be provided. The participant will also be able to schedule additional intervention visits in the event of an impending relapse. If additional support is required, contact can be made via telephone, email or through the patient application.

Initial weight reduction will be attempted by a meal plan and behaviour modification program, with emphasis on education for permanent lifestyle changes and behaviour modification program. The initial goal will be to reduce body weight by 10% from baseline in those with a BMI of equal to or greater than 27kg/m2.

Lifestyle Journal - Participants in the intervention group will be instructed to maintain a self-monitoring lifestyle journal, covering dietary intake and exercise.

Exercise – Physical activity is initially prescribed at low intensity for 20 minutes thrice weekly, based on participant's choice. This will be increased to achieve 210 minutes of moderate-intensity physical activity each week. Type and duration of activity is logged into the lifestyle journal.

CARDIO-METABOLIC RISK ASSESSMENT AND MANAGEMENT - Coexistent CV risk factors as indicated below, will be identified through the participant’s historical medical records and fasting plasma testing. Following identification, optimal management according to current evidence-based practice guidelines will be addressed by the specialist nurse/cardiologist during the 30-45-minute consultations and participants will be referred to dedicated specialists (e.g., diabetes and sleep disordered breathing) if indicated.

HYPERTENSION – Participants will be asked to measure their blood pressure (BP) twice daily using a home-automated monitor. In addition, exercise stress testing will be performed to determine the presence of exercise-induced hypertension. Increase in blood pressure to over 200/100 with exercise will be considered further evidence to optimize control. Initial therapeutic advice will include dietary salt restriction and weight loss with increase in aerobic physical activity. Pharmacotherapy will be initiated using angiotensin-aldosterone axis active agents by preference, and other agents where necessary to achieve a target BP of <130/80mmHg at rest on at least 80% of random acquired blood pressure readings as listed above. Further, echocardiography will be used to monitor any objective evidence of end-organ injury (e.g., left ventricular hypertrophy). Changes in the dose and number of anti-hypertensive agents will be recorded at each intervention visit.

GLUCOSE TOLERANCE - If fasting glucose is between 5.5 and 7mmol/L, a 2-hour oral glucose tolerance test will be performed. Impaired glucose tolerance (IGT) will be initially managed with lifestyle measures such as diet and aerobic exercise. If participants are unable to maintain glycosylated haemoglobin values below 6.5% after three months, metformin will be started. Participants with poor glycaemic control (HbA1c>7%) will be referred to a diabetes clinic.

DISLIPIDAEMIA – Management of dyslipidaemia will be in accordance with the evidence-based practice guidelines. Initially lifestyle measures will be used. Statins will be initiated if participants are unable to achieve LDL-Cholesterol of less than 100mg/dL after 3 months.

SLEEP APNEA - All study participants will complete a screening questionnaire to assess potential sleep disordered breathing and will be referred to a dedicated sleep disorder unit for overnight polysomnography if indicated. Continuous positive airway pressure (CPAP) will be prescribed in the presence of a clinically compatible history of sleep apnoea and sleep study results (Respiratory Disturbance Index [RDI] and desaturation levels). Generally, continued lifestyle measures with periodic evaluation may be pursued if RDI is between 15-30, CPAP will be prescribed if RDI is greater than 30.

SMOKING - The “5A” (Ask, Assess, Advice, Assist and Arrange follow up) structured smoking cessation framework will be adapted. Smokers will be offered behavioural support and follow-up within the specialised clinic. Pharmacotherapy may be included.

ALCOHOL - Written and verbal counselling will be provided aiming to reduce alcohol intake to no more than 3 standard drinks per week, with regular supportive follow up for alcohol reduction or abstinence.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Participants randomly allocated to Usual Care group will continue to receive care from their existing health care provider. Clinical investigation, treatment of AF, follow up, and risk factor management will be determined by the treating physician.

Control group

Active

Outcomes

Primary outcome [1]

A composite of all-cause mortality and hospitalisation. Medical records and death reports will be screened to assess hospitalisation and mortality. These events will be adjudicated by an independent Endpoint Adjudication Committee.

Timepoint [1]