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Table 2 Schedule of assessments

From: A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV

 BaselineVisit at 6 monthsVisit at 12 months
Inclusion and exclusion criteriaX  
Informed consentX  
RandomizationX  
Medical historyX  
Cardiovascular diagnosesX  
Previous cardiovascular interventionsX  
Comorbidities/cardiovascular risk factorsXXX
Physical examinationXXX
LaboratoryXXX
Resting electrocardiogramXXX
EchocardiographyXXX
MedicationXXX
Quality of life: EQ-5D-5 LXXX
Heart-related quality of life: HeartQoLXXX
Social support: SSUK-8; Illness-specific Social Support Scale Short version-8XXX
Depression: PHQ-9 (Patient Health Questionnaire depression module)XXX
Anxiety: GAD-7 (Generalized Anxiety Disorder scale)XXX
Well-being: WHO-5 (World Health Organization Well-Being Index)XXX
Medication adherence: MARS-D (Medication Adherence Report Scale) with 5 itemsXXX
Beliefs in medicines: BMQ (Beliefs about Medicine Questionnaire)XXX
Patient activation: PAM13-D (Patient Activation Measure)XXX
Serious adverse event XX
End of study  X