Monsenso has partnered with the University of Cambridge, Department of Psychiatry, to support the researchof using mHealth to help identify the possible causes of behavioural problems for those with intellectual disabilities.
The University plans to further their research and advance their understanding of behavioural problems in individuals with intellectual disabilities, which will initially include a group of people with Prader-Willi Syndrome. The study will be focusing on recording of information & data relating to their mental health state and try to elucidate the reasons for the behavioural problems.
Professor Tony Holland, Chair in Learning Disabilities in the Department of Psychiatry at the University of Cambridge said: “In the field of learning disabilities, we are asking questions like: “How do we detect poor mental health and behavioural problems early on?” By applying new technological solutions, such as Monsenso, we can not only improve how we collect data, but also how we can identify signatures that are an indication of poor mental health and behavioural problems.”
The Monsenso mHealth solution is used in a growing number of mental health innovation and research related studies. Monsenso is delighted to be working with Prof. Holland and team. The solution will be employed to monitor individuals and collect behavioural and physiological data via the smartphone delivered solution. The solution will collect daily self-assessment data, diary entries and record physiological measures, complemented by passive data collection by both the smartphone and wearable devices. This aim of the study is to use this data to determine the effectiveness of treatment on a number of physiological measures, and to compare physiological measures between groups of participants. Additionally, this study also wishes to see if this data can potentially identify triggers, or causes, of the behavioural problems of participants.
In previous similar research studies, clinicians, nurses and researchers were also asked to collect data about the client’s mental state and outbursts. However, this data was pen-and-paper based, which was clearly vulnerable to inaccuracies, as it was dependent upon the nurse’s ability to remember and record the events as soon as they occurred. It was also difficult for these notes to provide a longitudinal picture of the client’s behaviour over time. Applience of the technological solutions is a massive advancement in how researchers utilise and collect research data in this complex setting.
“Research is essential to find out which treatment and interventions work better for the patients and our mHealth solution can be used to enhance data collection and outcome measures that support this. Using this technology, Monsenso can help provide a detailed longitudinal overview about the individual’s mental state, which can help to identify signatures of behavioural patterns, and even forecast future conditions. We are proud to support the researchers of the University of Cambridge”, says Thomas Lethenborg, CEO of Monsenso.
Monsenso is proud to announce a new working partnership with UK’s telecare provider, Centra. The joint work will explore new, digital approaches to mental health service provision at Amy’s Place’ – Centra’s and Amy Winehouse Foundation’s (AWF) flagship addiction recovery service in East London.
The Monsenso mHealth app offers a comprehensive solution for managing a range of affective disorders, including depression, bipolar disorder, schizophrenia and borderline personality disorder. By utilising everyday smartphone technology, Monsenso supports individuals to self-manage their conditions whilst providing valuable insights to their mental health or social care support worker.
The Monsenso solution combines self-reported data and environmental sensor data to provide a balanced view of an individual’s behaviour and mood over time. The data can be accessed by nominated support staff to help inform diagnosis and treatment pathways.
Over the past ten months Centra’s Research and Innovation (R&I) team has worked closely with Monsenso as well as staff and residents at Amy’s Place to evaluate and configure the solution.
A pilot program will be established for six months, with testing conducted by a group of young women currently living at Amy’s Place and their support workers. Throughout the pilot, the service will be evaluated and supported by Centra’s R&I team to ensure that it meets expectations and maximises its benefits..
Centra is one of UK’s largest providers of telecare services delivering a range of life-saving alarm and monitoring services to social care workers, housing associations, health professionals, local authorities and individuals. Supporting over 100,000 customers across the country, our aim is to help people live safely and independently for longer. Our in-house Telecare team provide 24/7 call monitoring and support our clients with wellbeing checks, automated “I’m OK” calls and scheduled medication reminders. We also offer GPS-enabled devices for round-the-clock support away from home. As industry leaders, we provide cutting-edge technology solutions and tailored support that help meet customers’ ever-changing needs. To learn more, visit www.centragroup.org.uk
Monsenso is an innovative technology company offering a mHealth solution that optimises the treatment of mental disorders. Our mission is to help individuals, carers, healthcare providers and researchers overcome the burden of mental illness. Our solution provides a detailed overview of an individual’s mental health through the collection of behavioural data and self-monitoring, and by connecting individuals, carers and health care providers it supports self-care, informal care as well as formal treatment. Based on continued research and development, our team is committed to developing comprehensive solutions that fit seamlessly into the lives of individuals, increasing the quality and efficacy of their mental health and treatment. To learn more, visit www.monsenso.com
About the Amy Winehouse Foundation
The Amy Winehouse Foundation works to prevent the effects of drug and alcohol misuse on young people. We also aim to support, inform and inspire vulnerable and disadvantaged young people to help them reach their full potential. We are driven by a powerful vision for young people, a world where young people can flourish. To learn more, visit www.amywinehousefoundation.org
Developing our QMS is a continuous process. Recently, Monsenso has upgraded its QMS to the latest version of the standard EN ISO 13485 to the new revision: DS/EN ISO 13485:2016. Monsenso was audited by Bureau Veritas Certification Denmark A/S in June 2018 and found to be following the established procedures and the requirements of the standard DS/EN ISO 13485:2016.
So, what has Monsenso implemented in QMS to reflect the new standard and how does this affect users?
Quality management system with expanded risk management approach
According to the new version of the ISO standard, a risk based approach needs to be implemented in all the processes connected with the manufacturing of the medical device. This approach also include Monsenso’s suppliers.
In order to accommodate for this risk-based approach, Monsenso has implemented an extra layer of data security to our existing processes. This ensures that the evaluation / monitoring of our suppliers is proportionate to the risk associated with the purchased product. Monsenso’s critical suppliers are now placed on a risk level from I-IV, this ranking reflects the importance of the provided product relative to the medical device.
This implementation has helped to strengthen the control process of the suppliers, and helps to reduce risks that could potentially affect our customers and users of the product.
Closer to compliance with the requirements of the US market
Additionally, the new update of EN ISO 13845:2016 is in more alignment with US legislation and standards (FDA 21 CFR Part 820). Therefore, Monsenso is closer to meeting regulatory requirements of the FDA. FDA was a contributor to the new version and a lot of its regulation requirements are covered by this revision.
By upgrading their quality and security standards to become compliant with EN ISO 13845:2016, Monsenso has obtained an improved position to be aligned with worldwide requirements, including future compliance with FDA requirements on the US market.
Annual audit of ISO 27001 Information Security Management System
At the same time, Monsenso went through annual audition of ISO 27001. Compliance with this certification validates that Monsenso’s comprehensive information security practices protect its users and their information in accordance with internationally recognised standards.
The ISO 27001 standard ensures the secure management of customers’ information, intellectual property, and third party information by establishing methodologies and meeting key objectives for implementing information security.