Table 2.
Schedule of assessments
| 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 |