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Table 1 Primary and secondary endpoints

From: Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial

Primary outcome [evaluated at 12 months’ post implant]
• Device acceptance (FPAS)
Secondary outcomes [evaluated at 12 and 24 months’ post implant]
• Health status (SF-12)
• Patient empowerment (ICD-EMPOWER)
• ICD concerns (ICDC)
• Anxiety (GAD-7)
• Depression (PHQ-9)
• Health status (KCCQ-12; for patients with heart failure only)
• Return to work
• Time to first ICD therapy defined as anti-tachycardia pacing, cardioversion or shock
• Time to first hospitalisation due to a cardiac cause
• Mortality
• Cost of intervention program
• Healthcare costs
• Labour market absence
• Cost-effectiveness (i.e., incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)a
  1. aThis will be measured with the EQ-5D-5 L or captured from the patient’s electronic health record (EHR; e.g. number of outpatient visits, admissions, consultations with psychologists), and purpose-designed questions