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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

  Baseline Visit at 6 months Visit at 12 months
Inclusion and exclusion criteria X   
Informed consent X   
Randomization X   
Medical history X   
Cardiovascular diagnoses X   
Previous cardiovascular interventions X   
Comorbidities/cardiovascular risk factors X X X
Physical examination X X X
Laboratory X X X
Resting electrocardiogram X X X
Echocardiography X X X
Medication X X X
Quality of life: EQ-5D-5 L X X X
Heart-related quality of life: HeartQoL X X X
Social support: SSUK-8; Illness-specific Social Support Scale Short version-8 X X X
Depression: PHQ-9 (Patient Health Questionnaire depression module) X X X
Anxiety: GAD-7 (Generalized Anxiety Disorder scale) X X X
Well-being: WHO-5 (World Health Organization Well-Being Index) X X X
Medication adherence: MARS-D (Medication Adherence Report Scale) with 5 items X X X
Beliefs in medicines: BMQ (Beliefs about Medicine Questionnaire) X X X
Patient activation: PAM13-D (Patient Activation Measure) X X X
Serious adverse event   X X
End of study    X