SerPICoD Clinical Trial: Digital Health Monitoring for older people living independently

The SerPICoD (Service Demand Prediction based on Information from Connected Devices) study was a groundbreaking investigation into digital health self-monitoring by older people living independently with health conditions. Commissioned by NHS England and conducted by Camgenium through Hertfordshire and West Essex Integrated Care Board, this study achieved unusually high compliance rates to the self-monitoring regime with a cohort of 600 participants aged 65 to 95. It successfully overcame barriers resulting from digital inclusivity and technology adoption issues. Camgenium’s Xenplate, no code platform was used to develop the patient app and clinical trial management system. The user-friendly app and clinician dashboard was a key factor in the success of the study.

The SerPICoD study was designed to address the challenge of providing improved long-term healthcare support for patients aged over 65 living independently with health conditions.  The primary research hypothesis tested whether information captured by participants self-monitoring could predict demand for healthcare provision and prevent the crises that strip away independence and result in expensive emergency admissions by enabling healthcare providers to identify early signs of deterioration.

The study's innovative approach differed significantly from traditional condition-specific monitoring programmes. Rather than selecting participants based on specific diseases, SerPICoD used proxies for risk of exacerbation, including recent unscheduled care attendance, multiple clinical domains from Quality and Outcomes Framework (QOF), and medium to high frailty scores. This methodology made the findings applicable across diverse older populations with multiple comorbidities.

As part of the clinical trial design, significant care was taken in designing the participant app  and trial management technology to enable older patients to self-monitor long-term.  The success of this approach was evidenced by the excellent compliance rates of over 90% to the self-monitoring regime.

People aged 65-95 years typically have lower familiarity and comfort with technology than the general population, and this was a clear challenge that had to be addressed through the study design.  The participant app was specially designed to be easy to use even with poor eyesight or fine motor control.  It was designed to connect automatically to a wide range of measurement devices (such as blood pressure meters and pulse oximeters) via Bluetooth and it supported multiple measurement types.  It gave participants a simple interface through which they could answer questions about how well they were feeling and provided helpful information about the equipment and the study.  The study team developed protocols for training participants on the technology and for participant support, all managed through a comprehensive clinical trial system.

Participants used relatively low-cost standard medical devices.  Participants with digital skills were encouraged to install the study app on their own phones to reduce deployment costs. However, some participants found this too challenging and so were given pre-configured, locked-down smartphones with paired measurement devices as a set of equipment ready to use.

The study also included a support service, which was driven by the trial management system developed on Camgenium’s GxP compliant software platform, Xenplate.  The system ensured that participants were correctly onboarded and trained, and identified any people who were struggling so that they could be given the additional support they needed.   All participants were onboarded, trained and supported by telephone, none received a visit.  The telephone system was integrated into the study management system  and all calls were recorded as part of the study record and audit trail.

The clinical trial management system was developed using Camgenium’s secure GxP compliant Xenplate platform.  The Xenplate system has extensive functionality and can be rapidly configured to meet exact requirements.  It enabled the team to manage all aspects of the study including compliance management, device and asset management, and data collection and management as well as those described above.  The Reassure app issued to participants was an integral part of the system, and was used to capture measurements and other participant reported data.

Using the Xenplate platform, it proved straightforward to adapt the research management system as the study progressed to ensure it was always providing the functionality needed by the team.  This agile approach was crucial in adapting the system for the amended protocol that was used for the second of the two trial phases.  It also ensured that unforeseen challenges could be managed as they manifested.    As an auditable system, not only was all usage and data collected  in compliance with the requirements of Good Clinical Practice, all changes to the system itself were automatically recorded, meeting compliance requirements.

Download the full case study below.