Evidence Generation Case Study: Regimen

Regimen is a German-based company that has built the first CE marked, digital multimodal programme for individuals struggling with erectile dysfunction (ED). The Regimen programme combines patient education, targeted exercise, nutrition plans, lifestyle advice, stress management and optional tracking functionalities to empower users to improve their intimate and overall health.

Prior to starting the Regimen programme, individuals are asked to complete a health assessment including the International Index of Erectile Function (IIEF-5). This tool classifies ED into one of five categories ranging from severe (5-7 points) to none (22-25 points). End-users are then invited to complete the questionnaire every four weeks to track improvements to their erection as they continue with the programme.

Regimen joined Cohort five of the DigitalHealth.London Accelerator in 2020. During their initial on-boarding meeting with the DigitalHealth.London Team, it was established that evidence generation, through research collaboration, was a key priority. The team had identified their ability to gather key statistics from their Regimen App but were unsure how this should be used within an NHS Setting.

Start of the journey

As a German-based company, the Regimen team had limited knowledge of the NHS before joining the Accelerator. A key goal was to understand “how to demonstrate that their innovation is safe and effective to payers, practitioners, regulators and the patient”.

Regimen measures and analyses the effectiveness of the program through monthly health assessments, including the IIEF, filled out by their users. In their first cohort of several hundred users, 75 percent of individuals using the platform improved their erection on average by five points or more on the IIEF scale during the first 12-weeks of the programme. The platform also achieved a 40 percent retention rate six months after initial activation. However, the team were unsure of how to present these insights to key stakeholders and decision makers along with what else may be needed to demonstrate the effectiveness of their product. It was therefore recommended by their DigitialHealth.London NHS Navigator to join the Evidence Generator Workshop Series to gain an understanding of what evidence would be required to engage with NHS organisations.

Support from the Accelerator and the Generator

Regimen decided to attend all the workshops and subsequently took up offers of one-to-one advice sessions with experts and brokered meetings with potential research collaborators. Dedicated members of the Regimen team, Max Kersting (Co-Founder) and Giordano Blume (Director of Operations and Partnerships) attended to ensure inclusion of the possible learnings and insights into their long-term strategy and value proposition to the NHS.

The first workshop introduced the concept of evidence generation and why it was important to build into a company’s value proposition. Experts from the Generator Team presented the NICE Evidence Standards Framework for Digital Health Technologies. During the workshop, Regimen worked closely with their NHS Navigator to conduct a gap analysis based on their existing evidence and future plans. One key area identified was to understand the economic impact of the product created through improvements to the patient’s health and how this directly and indirectly affected health and social care budgets. Regimen also found that they needed to focus on gaining initial stakeholder feedback of the possible use of their lifestyle medicine product within the primary care setting.

The final workshop of the Evidence Generation Workshop Series gave the Accelerator companies the opportunity to engage in an interactive discussion with peers, academics, funding organisations, research support services and the Clinical Research Networks (CRNs). During this session the Regimen team were introduced to Dr David Mummery, a GP who is also a Research Fellow at the Department of Primary Care at Imperial College London and the North West London NIHR CRN Primary Care Lead. Dr Mummery gave first-hand examples of how patients routinely approach GPs with ED problems and offered to introduce Regimen to a group of GPs to discuss how a digital therapeutic platform  like Regimen could be adopted by primary care.

As a result of the introduction, the Regimen team joined Dr Mummery and his colleagues from the Self-Care Academic Research Unit (SCARU) at Imperial College London for a roundtable event, chaired by Dr Austen El-Osta (SCARU Director), to explore The Effectiveness of Lifestyle Medicine Approaches to Tackle Erection Dysfunction. The roundtable concluded that their proposed digital health solution will likely be welcomed by those who want to learn more about ED and how to tackle it using non-pharmacological interventions. It also highlighted that primary care and community pharmacies could play an important role in signposting individuals to the intervention once efficacy and cost effectiveness data is generated through a high-quality clinical study. The group also provided feedback that additional value would be achieved by collecting some “pre-diagnostic” data through questionnaires, particularly around the patient journey.  

Progress

Following on from the roundtable, Regimen are currently working on improving the functionality of the platform to streamline collection of the identified key data points to support evaluation and evidence generation. In time, this should enable Regimen to the demonstrate the impact of their product for patient benefit and to support evidence-based commissioning decisions. Further development is expected to allow the clinical team and service users to monitor the ongoing delivery of the pathway and to demonstrate local improvements to patient outcomes and possible cost savings. 

Looking to the Future

Regimen are collaborating with Dr Mummery and Imperial SCARU to develop a thought leadership piece earmarked for publication in a peer reviewed journal.

In addition, with oversight from Dr Mummery, Imperial SCARU is supporting Regimen in developing a mixed methods research study to investigate extant barriers and drivers for the widespread adoption and diffusion of the Regimen lifestyle medicine tool in the contemporary setting. The eSurvey and interview-based study will explore the knowledge, attitude and perceptions of patients, pharmacy and healthcare staff regarding the acceptability of using Regimen to positively impact the health and wellbeing of patients in tackling erectile dysfunction.

Regimen is currently one of 20 digital health companies on the DigitalHealth.London Accelerator programme.

The DigitalHealth.London Accelerator is a collaborative programme funded by London’s three Academic Health Science Networks – UCL Partners, Imperial College Health Partners, and the Health Innovation Network, MedCity, CW+ and receives match funding from the European Regional Development Fund.