Somerset patients play huge part in study aiming to slow the progress of dementia

Our trust has joined an international study that’s testing whether patients with a mild cognitive impairment can improve their cognitive function by using a digital health app.

Patients taking part in the Five Lives MED study are being randomised into two groups – one group receives the app, called Five Lives MED, which they will use three times a week for 12 weeks.

Those in the other group do not receive the app and will act as a ‘control group’. At the end of the study, the cognitive function of patients in the two groups will be compared.

At the beginning of study, patients in both groups undergo comprehensive cognitive testing, using several current standard methods of testing, in addition to a method of digital testing.

Patients will answer questionnaires relating to their behaviour, how their cognition impacts their quality of life, and their knowledge of Alzheimer’s. A study partner will also provide insight into the participant’s cognitive function.

In total, eight sites are involved in the study – six smaller ones in the UK, including our trust, and two larger ones in France. The aim is to recruit the same number of patients from each country.

Tracy Hallows, one of our clinical trials officers, says: “The aim of the trial is to see whether people with a clinically diagnosed mild cognitive impairment can see an improvement in their cognitive functioning by following some of the mental and physical exercises within the app.

“In addition to brain training ‘games’, the app provides achievable goals and aims to increase awareness of risk factors associated with cognitive decline, helping the participant to make positive life choices.”

Once patients have been identified and have consented to take part, the baseline assessment is completed, before patients are randomised – half to receive the app for 12 weeks and half to act as controls.

Patients are allocated to different groups using intelligent software to eliminate bias, ensuring that both groups of patients are comparable. During this period patients who receive the app are expected to complete a series of assessments (like brain-training games) at least three times a week.

“Our target is to recruit 15 patients, but we are able to over recruit, which is really positive,” continues Tracy. “This is a commercial study, and therefore, each patient brings money into the NHS.

“Recruitment is competitive across the six UK sites and so the race is on to get our numbers as quickly as possible.

“At the time of writing, 11 patients have been recruited, though we are blinded to how many of these have received the app. The reason for this is so that when we perform the cognitive assessments at 12-weeks we are not biased.

Five Lives is a small French start-up company that has already developed an app to promote brain health for older adults who may be at elevated risk for cognitive decline. It’s available for free in the UK in both Google and Apple app stores.

“The app in this study is the first version of a second app developed by the company for use by patients who have a diagnosis of mild cognitive impairment, and that’s where the NHS comes in as we’re best placed to identify patients in the early stages of the condition who would benefit in taking part.

“Research is considered very important within our trust, and evidence suggests that hospitals with a high research component also have improved patient outcomes. With the help of Dr Adrian Hayes, one of our consultant psychotherapists, who received funding as a research associate from the National Institute for Health and Care Research, we have raised awareness of research in mental health and dementia over the past two years.”

Tracy explains the important role that clinicians across the trust are playing in finding suitable patients for the trial.

“For this study in particular, we have offered our clinicians an opportunity to get involved in the research delivery process, and we’ve hopefully removed some of the unknowns and barriers associated with research.

“Our clinicians identify patients with cognitive impairment, and then our research team screens them for initial eligibility, before contacting suitable patients to have a more in-depth conversation, as there are a range of criteria they must meet to take part.

“Once this has been completed, and the patient is fully informed and happy to move forward, a baseline assessment is arranged.

“We are flexible in terms of where we conduct the assessments, inviting the patient into Musgrove Park or Yeovil hospitals, their closest community hospital or in their own home if they are unable to make the journey.

“The baseline assessment, which takes about two hours, includes three cognitive assessments, questionnaires and a knowledge quiz about Alzheimer’s, to find out how much they know already about the condition.

“The majority of our patients are very concerned about progression to dementia and reassurance is provided during the assessment that this prognosis is not predetermined.

“We also ask them to do a light physical challenge, and then at the end of the appointment, we randomise them using the computer software to either receive the app…or not.

“Those randomised to not receive the app are provided with information about how to best maintain their cognitive health. If they are randomised to receive the intervention, we help them install on their phone, show them how it works, and ask them to use it.

We ask that they use the app three times a week for at least half an hour, completing at least one full session a week. If the patient is not using the app as they should, we do receive notification from the study team and contact the patient to support their involvement.

“After 12 weeks we invite all patients in both groups back and carry out a repeat assessment, with the clinician doing the assessment unaware of whether the patient has the app or not, so that they remain unbiased.

Following this assessment, all patients are offered access to the app for six months, so they can either continue using it, or start using it and see how they get on. Their activity during this time is not monitored as closely but is important for gaining information on use of the app in a ‘real world’ setting.

“Six months later we do a short cognitive test over the phone, and this information is analysed to understand the longevity of any impact on cognitive function. This could be whether there was any improvement, if that improvement was maintained, or whether the app should be continued in the longer term.

“Our main barrier to recruitment is finding patients with suitable technology and technical ability to provide comprehensive data. However, all data is extremely valuable as you can have the best treatment/intervention in the world, but if a patient can’t use it or access it independently, then it’s worthless!

“People with mild cognitive impairment are naturally worried about it progressing to dementia, so they tend to be very willing to try something that might make a difference,” continues Tracy.

“We find that a lot of the patients who are involved in trials just want to help find a cure, as they know what an awful disease it is.

“A ‘by-product’ of taking part in research, is that it gives patients another opportunity to talk and have their anxieties heard. As part of the Five Lives MED study, every patient must have a ‘study partner’, a loved one or friend, who will support them through the process. The study also offers them both an opportunity to discuss their concerns and frustrations.

“Offering research in this area is massively interesting and immensely rewarding. You get a fascinating insight into the lives of our patients and their everyday challenges.”

Sarah Oakwood, an advanced practitioner and mental health nurse, who’s also the study’s principal investigator for our trust, says she feels very fortunate to be involved in this research.

“Research is one of the four key pillars of advanced practice and it was a great opportunity to apply that and work alongside Tracy, Ali and Adrian,” she says.

“My background has been within older adults’ mental health and dementia, so to be able to highlight the profile of people living with cognitive impairment is really important.

“This study is also working alongside the message that we are trying to promote as a service of the ways in which you can reduce the risk of developing dementia. Such as reducing cardiovascular risks and being more active, both physically and mentally.”

Dr Adrian Hayes, our consultant psychotherapist, adds: “The Five Lives MED project has been very successful in Somerset and has given us the opportunity to provide lots of clinicians with their first experience of research.

“It has been great to see the enthusiasm from our participants and their families, giving up their time to try and extend our understanding of dementia and how it could be prevented. The team has worked so hard in making the project happen and I’m very proud!”