New study underway on joint clinical trials between health tech and primary care

A first-of-its-kind randomised control trial in Northumbria is exploring the feasibility of cost-effective collaborative clinical trials, using digital interventions to support people with hypertension and depression and/or anxiety. Over a 12-week period, the Innovate UK-backed research project is involving patients by using Holly Health’s digital coaching service at home, emulating the real-world use of the service.

Cardiovascular conditions are the biggest cause of early deaths worldwide and over 19 million UK adults are affected by hypertension. However, as stated in the NHS Long Term Plan, “cardiovascular disease is largely preventable and the single biggest area where the NHS can save lives”.

Managing and preventing hypertension through lifestyle changes, including an improved diet and increased exercise, is critical. However, for many patients, self-managing the required changes becomes more challenging when combined with conditions such as anxiety and depression. For this reason, the need for innovative and integrated solutions that address both physical and mental health aspects is paramount.

Holly Health’s digital tool has the transformative potential of addressing the challenges posed by the comorbidity, enhancing self-management, reducing NHS costs, and improving national health outcomes.

Dr Justine Norman, Clinical Director for Quality and Research at Northumbria Primary Care, expressed excitement about participating in this unique feasibility study, highlighting the team’s interest in understanding how patients engage with and benefit from an innovative digital approach that address both physical and mental health conditions. Dr Norman added,

“The response from patients to take part in the research has been really encouraging. Now, we’re looking ahead to the study which has concluded this month and analysing the outcomes which will form a bigger six-month trial to measure the longer-term impact for our patients.”

The main outcomes of the study indicate strong patient engagement and positive lifestyle impacts. After using Holly Health for 12 weeks, 64 per cent of patients found the service useful, 69 per cent said they benefited from the service and 92 per cent found it acceptable as a digital health intervention. The app has helped improve participants’ lifestyles in the following ways, including:
●      Changes to eating habits
●      Reduced alcohol intake
●      Increased physical activity
●      Using the app to prompt better behaviours/habits

One participant finds the app very valuable and has become an integral part of her daily routine. She finds the ‘discovery’ resources and the notifications extremely useful. She also enjoys the reward feature and being able to tick off/complete a “habit” once she has done it. As an exploratory analysis, the study will look into changes in GP appointments and prescriptions after six months of using Holly Health. As an exploratory analysis, the study will look into changes in GP appointments and prescriptions after six months of using Holly Health.

Daniela Beivide, Chief Science Officer at Holly Health pointed out that prior studies for isolated conditions have demonstrated the positive impact of digital interventions, including a reduction of demand on services. She commented,

“We’re just as excited as our study partner, Northumbria Primary Care, to be investigating whether the same impact can be applied to supporting people with physical and mental health comorbidities.

If successful, there is huge potential to efficiently and cost-effectively scale the service for large populations to reduce strain on NHS services and create significant change in the economy of the country. We’re proud to be part of this cutting-edge approach where digital health companies and the NHS can partner to research and implement solutions at low cost and an accelerated pace”.

Holly Health’s intuitive app provides intelligent AI-powered coaching, habit reminders, education, and in-the-moment support to encourage regular actions for blood pressure and mood management, which empower individuals and improve self-management abilities.

The feasibility study is part of a Future Economy 12-month project funded by Innovate UK that has also enabled Holly Health to develop innovative features within its app, such as the Ecological Momentary Assessment (EMA) feature that gathers real-time user data for current mood and stress levels which can then be used to provide a more relevant and personalised coaching experience.