Health Technologies

Research assesses feasibility of collaborative clinical trials between health tech providers and primary care

A first-of-its-kind randomised control trial is being conducted across Northumbria to assess the feasibility of carrying out a low-cost collaborative clinical trial using digital interventions to support people with hypertension and depression and/or anxiety. 

Over a 12-week period, enrolled patients at Northumbria Primary Care took part in the trial by using Holly Health’s digital coaching service at home, emulating the real-world use of the service.

The Innovate UK-backed research project is being carried out to address the challenges posed by the comorbidity but also to highlight the transformative potential of digital health tools in enhancing self-management, reducing NHS costs, and improving national health outcomes.

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 changes in diet and increased exercise, is critical.

Although, creating the required changes through self-management becomes more challenging when combined with conditions such as anxiety and depression for many patients.

The need for innovative, integrated solutions that address both physical and mental health aspects is paramount.

Dr Justine Norman, Clinical Director for Quality and Research at Northumbria Primary Care, said: “We’re thrilled to be taking part in this unique feasibility study and we’re equally interested in understanding how our patients engage with and benefit from an innovative digital approach to support combined physical and mental health conditions.

“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 were recruitment rates and acceptability from patients who engaged with the service.

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% found it acceptable as a digital health intervention. The app has helped improve participant’s lifestyle in the following ways:

  • Changed eating habits.
  • Reduced alcohol intake.
  • Has joined a gym.
  • He has used the app to prompt better behaviours/habits.

Participant really values the app.

It has become part of her day and she is becoming quite attached to it. She finds the ‘discovery’ resources extremely useful.

She also finds the notifications very useful. She likes 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 using Holly Health for six months.

Daniela Beivide, Chief Science Officer at Holly Health said: “With prior studies for isolated conditions demonstrating the positive impact of digital interventions to patients and reducing demand on services, this is a clear next step.

“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.

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