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

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

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

T_{0 =} Baseline; T₆ = 6 months; T₁₂ = 12 months; T₂₄ = 24 months
^*Both patients in the treatment group and usual care group will complete all measures at T_0,T_6,T_12, and T₂₄
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

ISSN: 1471-2261