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Table 2 Patient-reported outcomes, cost-effectiveness and their assessment*

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

Construct Scale acronym Items T 0 T 6 T 12 T 24
Health status (generic) SF-12 12 X X X X
Health status (HF specific) KCCQ 12 X X X X
Depression PHQ-9 9 X X X X
Anxiety GAD-7 7 X X X X
Expectations to ICD treatment EXPECT-ICD 10 X    
Expectations to use of platform/app EXPECT-APP 6 X    
Experience with use of platform/app EXPERIENCE-APP 9   X X  
ICD patient concerns ICDC 8 X X X X
ICD empowerment ICD-EMPOWER 14 X X X X
Illness perceptions B-IPQ 9 + 1 X    
Adherence MMAS-8 8 X X X X
Type D personality DS14 14 X    
Device acceptance FPAS 18 X X X X
Loneliness UCLA 3 X X X X
Cost of intervention program Registry X X X X
Healthcare cost during observation period Registry X X X X
Labour market absence Registry X X  X X
All-cause and cardiac-related mortality Deaths Registry X X X X
QALY EQ-5D-5 L + VAS 6 X X X X
Cost-effectiveness/utility (ICER) €/QALY X X X X
Net-monetary benefit from health care and social perspective - X X X X
  1. T0 = Baseline; T6 = 6 months; T12 = 12 months; T24 = 24 months
  2. *Both patients in the treatment group and usual care group will complete all measures at T0,T6,T12, and T24
  3. B-IPQ Brief Illness Perceptions Questionnaire, DS14 Type D Scale, EQ-5D-5 L EuroQoL, EXPECT-ICD Expectations to ICD treatment questionnaire, EXPECT-APP Expectations towards use of app, EXPERIENCE-APP Experience with use of app, FPAS Florida Patient Acceptance Survey, GAD Generalised Anxiety Disorder scale, ICD-EMPOWER ICD Empowerment Scale, ICDC ICD Patients’ Concerns Questionnaire, KCCQ Kansas City Cardiomyopathy Questionnaire, MMAS-8 Morisky Medication Adherence Scale, PHQ-9 Patient Health Questionnaire, QALY quality adjusted life year, SF-12 Short Form Health Survey, UCLA UCLA Loneliness Scale, VAS visual analogue scale