The primary outcome is the feasibility of a subsequent phase III randomised controlled trial (RCT) according to pre-specified progression criteria. We are primarily interested in whether:
- the trial is appealing to participants (assessed by the recruitment rate)
- the PHOENIx intervention is acceptable (measured by adherence)
- we are able to collect routine data required to evaluate the effectiveness of the intervention
We will also evaluate:
- the recruitment and randomisation processes
The data collected will be used to review the sample size assumptions for the definitive trial to be conducted in the future.
Process outcome measures
Data will be collected on outcome measures that would be collected in a definitive RCT to ensure that there are no issues with the completion of these measures in preparation for the main trial. We will objectively assess the following:
- Recruitment
- Retention
- Intervention adherence
- Routine data collection
- Proportion of patient reported outcomes collected
- Proportion of economic data collected
Data in relation to clinical, social and patient reported outcomes will also be collected. These will include:
- health services utilisation
- social care outcomes (such as housing and level of debt)
- patient reported measures (including intervention acceptability and quality of life)