Many people are unsure about taking part in a research study. In this video, Ash talks about their experience of being recruited into, and taking part in, the CONNECT study.

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What’s one way we can save the NHS money?

Stop people needing beds in the first place. Easy right? If only it was!

Psychosis is the most common reason for referral into secondary mental health services, the social and personal impact of a psychosis episode is often catastrophic while beds for acute care cost the NHS millions of pounds a year. That is why I am passionate about finding ways to increase the reach of early intervention in psychosis care.

My journey into clinical research was a little later than some. Initially, I followed a creative path into antique furniture restoration, but by my mid-30’s I was unfulfilled.

I began to feel a strong need to do something more meaningful with my life and help address this problem. After some time spent volunteering for the mental health charity Mind and studying for a psychology degree, I was fortunate enough to get my first taste of the world of mental health research with Professor Mark Hayward at the Sussex Voices Clinic; a research clinic that offers brief talking  therapy for people distressed by voice-hearing experiences.

My special interest in digital implementation developed when I was lucky enough to win a PhD studentship, funded by the Economic and Social Research Council, sponsored by Sussex Partnership NHS Foundation Trust and under the expert supervision of Professor Kathryn Greenwood. In response to the COVID-19 pandemic and social distancing restrictions, the untapped value of digital applications was suddenly brought into sharp focus.

If it wasn’t obvious before, the value of implementing digital devices as a way of supporting clinicians became clear along with the myriad of challenges to implementation. Digitalisation is the future, and it is important that the NHS keeps up and finds ways to modernise. We know that many people who use our services welcome care delivery in this way. Devices that remotely deliver information or monitor symptoms can offer support in-between clinical appointments, particularly for people who find it difficult to consistently attend in-person appointments for a variety of reasons. It has the potential to empower service users to take ownership of elements of their recovery.

I am proud to be project manager of CONNECT in Sussex. The CONNECT digital study is a large national study that is collecting data about symptoms and daily life from participants using smartphones and wearable activity trackers. The aim is to be able to monitor changes in mood, symptoms, and behaviour to spot warning signs of relapse early, ultimately enabling support to help clinicians adjust care accordingly and where possible to prevent hospital admission.

More information about CONNECT:

• We are recruiting until 2027 and looking for participants with a psychosis diagnosis (F20-F29) who have relapsed in the last two years (which can be by clinical judgement)
• Benefits to participants are that they get a smart phone and activity tracker (Fitbit or Galaxy watch) that they can keep at the end of the study. They get paid up to £100 for their time and they get £10 per month towards data costs.

You can find out more about the CONNECT study by contacting your local research team

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Access to the internet and digital technology has become a growing part of everyday life, changing how we communicate, learn, relax and work. We have become so used to living our lives on smart devices, that it can feel difficult to imagine a time without them or forget that others in our communities don’t have this access. Yet, digital exclusion remains a key issue in the UK, impacting older adults, disabled persons and low-income individuals the most. Digital exclusion can lead to increased feelings of loneliness and social isolation, paying more for goods, less access to services and feelings of having “no voice” in a digital world. Since COVID-19 the digital divide has become much more obvious and there has been a nationwide push to reduce this. However, the solution to digital inclusion isn’t just about having access to this technology, it is also about helping people to understand how to use and feel confident in using them in their day-to-day life.

As a site, we know that Glasgow is disproportionally impacted by digital exclusion, experiencing some of the highest levels of exclusion in the UK, making CONNECT a very exciting study to bring to the city. As we continue to recruit participants in Glasgow, we wanted to share the positive impact we are seeing in our city from the perspective of our participants.

With CONNECT, not only are we growing vital research in psychosis, but we are also able to give people access to digital technology which they are able to keep at the end of their participation. As part of the project, we have one appointment where we support participants to set up the devices, download the study app onto the phone and familiarise themselves with the equipment. We are then able to spend dedicated “tech” time each week by phoning participants, where we hope to help grow confidence in using this technology by working through difficulties and answering any questions.

Prior to CONNECT, Alex* never had an email address, used a smartphone or smartwatch – something we are seeing a lot in Glasgow. At our tech appointment, we wanted to make sure we were working in a way that was accessible to Alex and made sure to check they were understanding us and were able to ask questions. We began by setting up an email address, exploring what we can use an email account for, picking the name Alex wanted to use and password protecting this. We then set up a new Samsung phone, where we started by showing them how to use the touch screen, unlock the phone and use the built in apps. In this appointment, Alex sent their first ever text message and made their first mobile phone call! We then set up a smart watch, focusing on how to use this device, what the watch can be used for (thinking about step count, heart rate, sleep) and picking some fun new watch faces. Alex shared their own thoughts on how exciting it was to have these devices and how it felt to be able to interact with the digital world, discussing all the things they hoped to do, from using online banking to using social media and texting family. Alex also shared with us their worries about not being able to use the devices as others do and feeling overwhelmed about this. We spent time speaking through these worries, answering Alex’s initial questions and reassuring them that we were always a phone call away if they had any worries about the devices.

Following onboarding, we planned weekly phone calls where we had dedicated time to answer any questions and work through any difficulties. Before one call, we noticed that the data information from the devices was not “flowing” into the database. We contacted Alex, explained what we had noticed and if we could try to work through some steps to get this information to “flow” again. Alex expressed some worries about their ability to do this but stated they would like to try the steps to see if we could fix this without setting up another face-to-face appointment. We were successfully able to find the reason the data wasn’t flowing and resolve the issue, having a “mini celebration” on the phone at this achievement. We spent some time speaking about the skills Alex had already begun to develop, which was a huge moment for both Alex and the research team.

Throughout the weekly tech support phone calls, Alex has shared with us their growing confidence in using the equipment and the things they had learned. They also shared with us their joy at being able to communicate much easier with loved ones, and feeling they were more accessible by being able to send a quick text message. Alex also experienced their first ever “butt dial”, calling a member of the research team by mistake and having a chuckle with them about this. Anyone who has used a mobile phone knows all too well this familiar feeling!

As we move to monthly check in calls with Alex and continue to welcome more people to the study, we wanted to pause and reflect on all the things CONNECT is achieving. We live in a dynamic and changing world but it’s important to remember the whole picture of the communities we live in and how we can support everyone in them. Thanks to this Wellcome trust funded study, we hope we can CONNECT people a little bit more.

*Please note: names have been anonymised and pseudonyms used for this piece.

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Designing the mobile app for the CONNECT study was a collaborative process that emphasised the importance of user-centric design. The app, which plays a central role in the study’s goal of predicting and preventing psychosis relapse, was developed through a series of co-design workshops with the study teams Lived Experience Advisory Panel (LEAP).

Co-design

The design process began with a series of co-design workshops. The goal of these sessions was to ensure the app was intuitive, accessible and met the needs of its users.

In the initial workshops, we focused on understanding the daily challenges individuals face when using technology. Participants shared their experiences, highlighting the importance of engaging interface design, accessible content, non-intrusive monitoring and the need for privacy and data security. These insights were invaluable in shaping the app.

Figure 1: The iterative user research process

Iterative Development: Rapid Prototyping and Feedback

With a clear understanding of user needs, we moved on to prototyping. Early versions of the app were created using prototyping software and shared with workshop participants for feedback. This iterative process allowed us to refine the app continuously. For instance, participants emphasised the need for an engaging interface, leading to the development of visually appealing design elements and progress-tracking features.

Feedback also highlighted the importance of accessibility, in relation to reducing cognitive load. Participants wanted the ability to use the app without having to concentrate for long periods of time. Readability, in particular, was highlighted as potentially problematic. This input guided the integration of features to aid readability. These included support for screen readers and the development of a ‘dark mode’ for the app.

Figure 2: Evolution of prototype

Balancing Functionality and User Experience

One of the significant challenges was balancing the app’s functionality with an optimal user experience. As well as collecting passive data via their phone and wearable, the app needed to collect comprehensive amounts of active data, including digital questionnaires. Users are prompted via notifications to respond to the questionnaires, which provide vital data to the CONNECT study. After speaking with participants, we created a notification management system, so that the participants could easily control the frequency of notifications they received. This approach ensures that users remain engaged without feeling overwhelmed by the data collection process.

Privacy and Data Security

Given the sensitive nature of the data collected by the app, we created a series of diagrams to explain the ‘data journey’ of participants’ data. The diagrams were used to explain complex flows of data in a transparent and understandable way.  This would provide participants the information they needed about how their data was being used.

Software Development for the CONNECT project

Once the graphical designs of the app were finalized by our designer, our software team started working to build the software for CONNECT. We systematically transformed the designs into a fully functional application. For the CONNECT app, we employed a cutting-edge technology that facilitates simultaneous development for both Android and iOS platforms. This dual-platform approach significantly accelerated our release timeline, allowing us to deliver the app for the project more swiftly than the traditional method of building for each platform independently.

Despite our best efforts and planning, it is inevitable that challenges and deviations will arise. To effectively manage these uncertainties, we adopted an Agile development approach. This involved segmenting the app development process into three-week sprints, each focused on achieving specific milestones. At the conclusion of each sprint, we conducted comprehensive testing of the developed features and implemented necessary adjustments based on the feedback received from the project, testing and lived experience teams. This iterative approach not only allowed us to refine and enhance features progressively but also ensured that the application’s functionality aligned with real-world user requirements and expectations.

Figure 3: Agile development methodology

Passive data, challenges and privacy

Our most significant challenge was collecting data from various phones and wearable devices. CONNECT supports numerous devices, including Apple Watches, Fitbits, and Samsung Watches, each requiring individual system integration. Furthermore, we needed to obtain approvals from Apple and Google to access data from these phones and watches; these approvals required completing documentation and responding to technical and research queries.

Given the vast amount of data that the CONNECT project will generate, we needed to ensure efficient data storage and transfer. To address this, we implemented advanced compression techniques to minimize the load on devices. Additionally, we utilized background processing to facilitate seamless data transfer to our servers and allow the app to be used normally while transfer is taking place. This approach ensured that we could handle the extensive data efficiently without compromising device performance or user experience.

Given the nature of the app and its handling of personal information, security was a paramount concern throughout the development process. We implemented stringent measures to ensure that user data remains completely isolated from other aspects of the application. All personal data is transmitted to highly secure vaults, which are protected with multiple layers of security protocols. Access to this sensitive data is restricted to a very limited group of authorized personnel. This robust security framework guarantees the protection of user information and upholds the highest standards of data privacy and security.

Each phase of the development was followed by extensive testing – both automated and manual user testing – to ensure that the app was defect-free and fit for use in the study. We are delighted that that the CONNECT app is now in live use in the study and we look forward to seeing the results of the research.

Figure 4: Screenshots from the final CONNECT app

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The CONNECT Study was launched on 11th March with over 120 people in attendance.

Guest speakers included Professor Miranda Wolpert MBE, Director of Mental Health at Wellcome, Professor Sandra Bucci, Chief Investigator for CONNECT, Alex Kenny, Public Involvement in Research Lead at The McPin Foundation and Professor Richard Dobson, Professor of Medical Informatics at Kings College London and University College London.

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The CONNECT Study is launching on 11 March! It’s an online event and registration is free.

REGISTER HERE or scan the QR code below

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The aim of the CONNECT study is to produce a digital remote monitoring system (DRM) whereby healthcare professionals and service users receive an early warning alert about a potential relapse of psychosis and intervene in a timely manner. The DRM system includes a smartphone app, a wearable and a digital data capture platform which collects information about a range of clinical and health factors. 

  “The thought that I might have a relapse in the future fills me with fear” says Alison, an expert by experience for CONNECT. “But even with this constant fear, a relapse takes me by surprise. How could this happen again? What did I do wrong?”  

 Relapse also has a huge impact for Alison. “A relapse of psychosis is a major disruption to my life” she says. “And it not only affects me but all the people I care about. It is disturbing and so confusing. My mind is over processing thoughts in a manic state. I experience ideas, feelings, and experiences but not in a rational way. I cannot process or learn from any of it. There’s also a breakdown in relationships, financial loss and the inability to work. I have become my own worst enemy. One day I wanted to die taking all the steps and methods necessary. I was fighting for my life, physically and mentally.”  

Alison believes the CONNECT app could play an important role in preventing relapse. She also thinks it could be empowering. “An app can help with future planning. If the app makes me feel confident and secure, I am free to learn about my condition.” 

 A member of the Lived Experience Advisory Panel, Katherine, experiences what has been termed the fear of relapse. “I regularly think about how much I do not want to be hospitalised again”, she says. “I fear medical professionals knocking on my door announcing that I am having a relapse and taking me to hospital based on their own poor observation skills and very little other evidence. This is something that has happened to me before.”  

Katherine takes her medication as prescribed, and she worries that she might experience a relapse and be sectioned if she changes her medication. “Without my medication I could become very unwell in a matter of days and my fear is that things could become out of control and my life could be disrupted yet again. If my medication is changed while I am having a relapse in hospital I am locked up with no freedom or autonomy. I am stripped of my human rights and there is no optimal solution for my treatment or care. At this stage it feels like nothing could make me better. Recovery from relapse is slow and takes far too long. An app that helps prevent relapse getting to this stage could make a big difference.” 

Expert by experience, Sally, says that she finds worrying about relapse counterproductive and benefits from psychological treatments. “Worrying about something such as relapse is inevitably counterproductive. Time and practice help. And the times I have relapsed, CBT [Cognitive Behaviour Therapy] for psychosis has proved a very handy tool.” Sally hopes the CONNECT app will help to reduce fear of relapse. She also believes it will be valuable in capturing personal indicators of relapse and will support her to be better prepared for and potentially prevent relapse in the future. 

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