Randomisation andbaseline | 4weeks*±1week FU visit | 6 months±2 months FU visit | 12 months±2 months FU visit | |
Confirm eligibility | ✓ | |||
Seek informed consent | ✓ | |||
Randomisation | ✓ | |||
Medical history† | ✓ | |||
Medication review | ✓ | ✓ | ✓ | ✓ |
Physical examination | ✓‡§ | ✓‡§ | ✓‡§ | |
Office blood pressure | ✓ | ✓ | ✓ | ✓ |
Pulse | ✓ | ✓ | ✓ | ✓ |
Standard care blood tests | ✓‡ | ✓‡ | ✓‡ | |
Height | ✓‡ | |||
Weight | ✓‡ | ✓‡ | ✓‡ | ✓‡ |
Administer EQ 5D-5L | ✓ | ✓ | ✓ | |
Resource use (Follow-Up CRFs) | ✓ | ✓ | ||
Dispense trial medication*¶ | ✓ | |||
Adverse event review and evaluation | ✓ | ✓ | ✓ | |
Adherence | ✓ | ✓ | ||
Qualitative interviews** | ✓†† | ✓ |
*Carvedilol arm only.
†Including aetiology of liver disease and past medical history (diabetes, ischaemic heart disease, pulmonary disease). AUDIC-C score will also be calculated where appropriate.
‡Taken from clinical records.
§Liver stiffness measurement using Fibroscan where available and appropriate.
¶Medication may initially be dispensed by site but can subsequently be dispensed by the participant’s community pharmacy.
**Pilot phase only.
††Follow-up qualitative interviews will be between 6 and 12 months.
CRF, Case Report Form.