Efficacy of a web-based health care innovation to advance the qualIty of life and care of patients with an Implantable Cardioverter Defibrillator (ACQUIRE-ICD): A randomized controlled trial

Aims: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. Methods and results: This national, multi-site, two-Arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-Time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B =-2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B =-0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B =-0.39, 95% CI (-0.96; 0.18), P = 0.18]. Conclusion: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.