Background
Atrial fibrillation [AF] is the most common cardiac arrhythmia. In Denmark alone, about 20,000 new patients are diagnosed each year. Age is the most common risk factor for AF. Given the ageing of the population, the prevalence of AF has increased threefold during the last 50 years and is now a major public health challenge.
AF is a potentially debilitating disease, with 28%-38% experiencing depression and/or anxiety. Depression can be both a consequence of being diagnosed with AF and a trigger of the onset of AF. Studies show that depression is associated with a 25% increased risk of new onset AF. Depression also comprises a barrier for adherence to treatment for stroke prevention in patients with heart failure and concomitant AF. Furthermore, depression is linked to poorer health-related quality of life (HRQoL), worse symptom burden, higher AF recurrence rates, excess mortality, and increased healthcare utilisation.
Why the HOPE-AF study?
HOPE-AF represents a novel and pioneering approach to improve HRQoL and prognosis of patients with AF through the prevention of depression, a seminal and debilitating risk factor for the onset of AF and worsening AF prognosis. In collaboration with patients, we will co-design an online psychological intervention that targets risk factors for depression with respect to preventing depression. The intervention will be delivered via a GDPR-secured online platform. This is an innovative solution for care delivery, enabling patients to access the intervention anytime and at their convenience, which may enhance adherence.
Objectives
The overall purpose of the HOPE-AF project is to prevent depression and improve the health outcomes of patients with AF.
Specific objectives are to:
I. Develop a therapist-assisted eHealth intervention (HOPE-AF), using a user-centred and patient and public involvement (PPI) design, targeted to preventing depression in patients with AF.
II. Assess the feasibility of the HOPE-AF intervention on depression, patient satisfaction and retention (barriers and facilitators) and procedures with respect to recruitment and implementation in clinical practice.
III. Evaluate the clinical effectiveness and the cost-effectiveness of the HOPE-AF intervention + treatment as usual (TAU) as compared to TAU alone.
Study design and methods
We will undertake a 3-phase programme of research that uses a mixed-methods approach that includes both quantitative and qualitative methods, consistent with the MRC framework for developing and evaluating complex interventions.
Phase 1: invention co-development with patient and public involvement (PPI);
Phase 2: feasibility study;
Phase 3: multicentre randomised controlled trial (RCT).