Start of Patient Recruitment for the Phase V Project

Start of Patient Recruitment for the Phase V Project

May 28, 2025

Copenhagen, Denmark 

We are delighted to share an update on PhaseV, a national cross-sector innovation effort, supported by Innovation Fund Denmark, that aims at advancing decentralised, real-world clinical studies in Denmark.

ABOUT THE PROJECT

PhaseV is developing a new, digital model for running clinical studies that brings monitoring closer to patients and clinicians over longer periods. It collects patient-generated real-world data via questionnaires and connected devices, presenting insights to patients in an app and to clinicians in a web portal, both developed by Monsenso. The programme will pilot three proof-of-concept studies in obesity, diabetic foot ulcers, and chronic spontaneous urticaria.

Recruitment has begun for the obesity research arm of the PhaseV project

Steno Diabetes Center Aarhus is recruiting participants for a 24-week, fully online study. Participants receive personal guidance and support from clinical dietitians while data are gathered digitally at home using a smartwatch, connected scale, and the study app.

The primary objective of this study is to assess the feasibility of enrolling participants with overweight or obesity into weight management programs within a decentralised clinical trial (DCT) framework, and to evaluate the ability to reliably monitor body weight in such a setting. In addition to feasibility, the study seeks to determine whether relevant health gain parameters can be accurately captured by leveraging participant compliance data obtained through digital device usage. This approach aims to provide insight into both adherence and the quality of data collection in a decentralised environment. Another important objective is to investigate the impact of weight management interventions on health outcomes over the course of the study. By analysing longitudinal health data collected remotely, the research intends to evaluate the effectiveness of these programs in producing measurable improvements. Finally, the study includes an evaluation of participants’ reported satisfaction with the devices used, as well as their perspectives on the overall feasibility of the decentralised setup. Incorporating these user-reported outcomes ensures that the study not only addresses clinical effectiveness but also considers the practical and experiential dimensions of trial participation. Taken together, these objectives reflect a comprehensive effort to explore both the scientific and operational dimensions of conducting weight management research through decentralised clinical trial methodologies.

If the project may be relevant to citizens or patients you support (exclusively in Region Midtjylland), please share the project page and participation form. 

cross-sectorial COLLABORATION

The consortium is led by Monsenso and includes partners across academia, healthcare, industry, and innovation: Aarhus University, Research Unit for General Practice (FEAP), Bispebjerg Hospital, Steno Diabetes Center Aarhus, Aarhus Municipality, the Danish Technological Institute, the Alexandra Institute, the Copenhagen Institute for Futures Studies, Danish Life Science Cluster, Novo Nordisk, and Novartis.

PhaseV aims to deliver a scalable digital platform for effective decentralised recruitment, continuous data capture, and phase-V style real-world studies that can strengthen patient care and decision-making.

For more information about the project and its progress, visit the PhaseV website or the Danish Life Science Cluster project page, or follow Monsenso on LinkedIn.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

Solution
Carelink and Monsenso partner to deliver digitally enabled nationwide mental health services

Carelink and Monsenso partner to deliver digitally enabled nationwide mental health services

Dec 14, 2023

Carelink Nærhospital and Monsenso entered into a partnership and expect to deliver the first digitally supported mental health services in January 2024. 

Carelink Group, Denmark’s largest private health and welfare services group, and Monsenso, a leading provider of validated digital mental health solutions, have entered into a groundbreaking partnership that will redefine the way mental health services are delivered for the benefit of patients, healthcare professionals, and the healthcare sector as a whole.

Mental health is a crucial part of our society, and the need for innovative solutions to address challenges in this area has never been bigger. Carelink’s extensive experience in delivering high-quality healthcare services, combined with Monsenso’s advanced digital health solution, has the potential to create lasting value for both the healthcare sector, the work of healthcare professionals, and particularly for patients. The partnership aligns with the Danish government’s initiatives in psychiatry and the recently presented Finance Act for 2024.

Key points in this partnership include:

  1. Highly scalable digitally supported healthcare services: The partnership creates an innovative foundation that integrates traditional mental health services with advanced digital solutions. This comprehensive offering will provide individual users with tools for digital self-help, self-monitoring and effective remote clinician follow-up before, during, and after treatment.
  2. Addressing workforce issues: The shortage of qualified personnel in mental health is a challenge. This partnership aims to alleviate the problem by optimising resources and leveraging technology to expand the reach of healthcare professionals, enabling them to serve a larger number of patients.
  3. Reduced waiting times: Long waiting lists for mental health services are a significant problem nationwide. The collaboration will streamline the process and offer timely assistance through a combination of digital solutions and remote follow-up, ensuring that patients receive the support they need promptly.
  4. Improved patient experience: Patients will experience a more patient-centered and convenient approach to assessment and treatment for mental disorders. The partnership will enhance the patient experience, promote patient involvement, and provide effective follow-up, support, and treatment.
  5. Quality treatment: The combined offering will promote better treatment outcomes, as patients will have the necessary tools and support for digital self-help, self-monitoring, and effective remote follow-up. This is expected to lead to improved quality of life, more efficient processes, and a reduction in relapses.

“We have entered into this partnership to meet the pressure on psychiatry and the healthcare sector today. We aim to create a Digital First but not Digital Only offering, making waiting lists, assessment, and treatment processes more patient-centric. We believe we can achieve this by leveraging the latest clinically validated technologies to effectively follow up on treatment – also at a distance and in patients’ own homes,” says Maria Pico Almsgaard, CEO of Carelink Nærhospital.

“The potential in the partnership to create easily accessible, nationwide offerings is significant. Far too many patients are waiting for treatment and not provided with the effective, digitally supported offerings that they would like. Better assistance for children and young people, as well as digital offerings, is a priority for the government, and that’s why we have also started with digitally supported offerings for children and young people, but with new pathways continuously added,” says Thomas Lethenborg, CEO of Monsenso.

Click the button below for more information about the Monsenso solution.

Solution
Eating disorders (Infographic)

Eating disorders (Infographic)

Nov 13, 2015

It is estimated that 50% of teenage girls, and 30% teenage boys use unhealthy weight control behaviours such as skipping meals, taking laxatives, and smoking cigarettes.

an infographic of facts about eating disorder