With recruitment to the second phase of the EMPOWER study well underway in both Glasgow and Melbourne, Simon Bradstreet (Trial Manager) and Helen Whitehill (Research Assistant) provide an update on recent progress.
The second phase of research in the EMPOWER study involves recruiting people from six mental health teams in the NHS Greater Glasgow and Clyde area and people from two teams in Melbourne, operated by NorthWestern Mental Health. This part of the study involves what is known as a Cluster Randomised Controlled Trial. This means that half of the teams involved will be randomly allocated to the EMPOWER App and system and in the other teams care will continue as per usual.
We are extremely grateful to all the teams involved across both sites for their time and support, not least because they are all working under considerable pressure and face competing demands on their time.
What we now aim to do
We have a number of aims for this part of the study. These include:
- Evaluating the EMPOWER App, which is designed to help people with experiences of psychosis to stay well. You can read more about how the app and system works here.
- Assessing how acceptable and safe using digital technology in this way is. Our study is regulated by the Medicines & Healthcare products Regulatory Agency (MHRA), which means that we are going to considerable lengths to test both safety and performance. We believe this is the first mental health App be subject to this level of rigorous testing.
- Comparing a range of outcomes between people using the App and those receiving treatment as usual to see what effects the App and approach might have. Things we measure include whether or not people have experienced relapses in psychosis, service use, recovery and relationships. We also ask designated carers and keyworkers about their views and experiences.
- Informing how we would run a larger multi-site trial, which is our longer-term intention.
To date we have been making good progress in working with the teams and keyworkers in them to screen for potentially eligible people in receipt of their services. The response by teams has been outstanding. From the eight teams, 106 keyworkers have consented to take part and none have refused to participate in the study. Keyworkers are working with us to identify potentially eligible participants and supporting our Research Assistants to recruit people in receipt of services and where requested, their carers.
Some important numbers are summarised in our infographic below.
Some early observations
When we speak with people we are seeing really good levels of interest in both the study and the potential for the App to offer a new means of helping people to support their mental health and recovery.
The EMPOWER trial includes informal carers and we have been heartened by positive feedback on that from the family and friends who have consented to take part in the study so far.
Next steps for us are to continue with our screening and recruitment efforts. We have also started completing initial research assessments with people who have agreed to take part. Once we have completed these assessments teams will be randomised in pairs and at that stage we will start setting people up to use the App for a year.