The Future Challenges: Replenish-ME

Andy

Andy

Senior Member (Voting rights)
Replenish-ME is a project designed to help those diagnosed with Chronic Fatigue Syndrome (CFS) / Myalgic Encephalomyelitis (ME) develop a greater understanding of how their day-to-day activities impact on their health and levels of energy. It is part of our wider Future Challenges Programme.

Bath Centre for Fatigue Services (BCFS) is working with innovator KiActiv® on the Replenish-Me project. They will use the KiActiv® Health technology to support the BCFS programme and provide a way to more objectively track a person’s physical activity levels to support and enable patients to better manage their condition.
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Building an evidence base

Replenish-ME is one of two projects being piloted under the theme of ‘Keeping Healthy at Home’ which forms part of the Future Challenges programme. KiActiv® have already been commissioned in Gloucestershire to support people with type 2 diabetes and other long term conditions to increase their physical activity levels. However this will be the first time it will be used in the NHS to help patients optimise physical activity in order to facilitate better control of their fluctuating energy availability.

Through the Future Challenges programme, we work closely with innovators and local partners including clinicians, commissioners and the chosen trial sites to pilot their innovations and evaluate them in a real-world setting, building evidence to support possible future commissioning decisions and opportunities. We will be working with the South West Academic Health Science Network to independently evaluate this project.
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https://www.weahsn.net/our-work/sup...hallenges/the-future-challenges-replenish-me/

 
Just been reading up on this am a bit confused; are they carrying out a trial of the product or just going ahead with the therapy without any evidence?

Also have they been a bit fast and loose with the name to make it seem tailored to pwME?
ie "Replenish-ME project" as opposed to the "Replenish-Me project"

I can't find anything specifically relating to ME on their research pages:


but there is a 'general' one so maybe they are using that as 'evidence' as ok to try out on ME patients?

The Mi-PACT Project
The Mi-PACT project is a randomised control trial funded by the National Prevention Research Initiative and sponsored by the University of Bath. Its purpose is to examine whether personalised multidimensional physical activity is effective for improving physical activity behaviour, reducing future disease risk and improving general wellbeing in an at risk population.

The Mi-PACT project is using the KiActiv® Health software to enable the use of multidimensional physical activity profiles in delivering positive behaviour change outcomes. This 12-week programme was developed to incorporate proven behaviour change techniques, as well as visualisations designed with users which are shown to:

  • make complex information easy to understand
  • enhance knowledge of their physical activity
  • inspire confidence to change and self-manage
We have seen remarkable results for engagement, adherence and sustained behaviour change, which we will publish in the near future. If you require any further information prior to publication, please contact us.

Papers released to date:

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https://kiactiv.com/research/

they are also 'piloting' it for COPD ( another classified under PPS)


I think that gathering data on objective measures is a good move, but if it is being done in conjunction with essentially a GET program based on Psychosocial methods I worry that the data may be misinterpreted and thus the wrong 'advice' given to the patients.

And that when the treatment period is over it might be another case of square pegs in round holes in terms of 'making the data fit' with their model of fear/avoidance/deconditioning.
 
I really don't see how this could be of any relevance. A habit of exercise is important and beneficial in type 2 diabetes and so you want to encourage that behavior. Applying the same approach to a disease that specifically does not benefit from an increase in exercise makes no sense. Most pwME do the most they already can and not knowing this is disqualifying. Any increase in activity in one place has to give in another and we are painfully aware of just how limited we are, it's not even relevant information (other than, I guess, the people who think we just feel tired, or whatever).

It's not clear exactly what is being monitored but as has been explained on twitter there is no heart monitor, pretty much the only relevant thing to monitor. It also adds enormous confusion considering the typical advice ME patients get from NHS personel.

I'm sorry folks but you are not helping when you don't even understand the basics of the problem.
 
Sly Saint said:
Just been reading up on this am a bit confused; are they carrying out a trial of the product or just going ahead with the therapy without any evidence?
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Sly Saint said:
I think that gathering data on objective measures is a good move, but if it is being done in conjunction with essentially a GET program based on Psychosocial methods I worry that the data may be misinterpreted and thus the wrong 'advice' given to the patients.
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I had a look too. It seems they are in the process of researching this product for people with the sort of conditions where increasing activity is healthy. There is no mention on the company website of any knowledge or planned research for ME.

It seems their product is a wearable movement monitor that measures movement in 3 dimensions, but does not count steps or heart rate. This is linked to an app which users learn to interpret and use to better understand their activity with a view to increasing it, with the guidance of a company 'mentor' in six 20 minute telephone conversations spread over 12 weeks.

I couldn't see any mention of monitoring symptoms as well. The sole target seems to be to help people learn how to increase their activity by becoming more aware of how much they are doing now and being prompted to explore ways to integrate more activity into their daily lives.

I think I might write to the company and the clinic to ask for a copy of their research protocol and ethics approval for this pilot intervention. (I bet there isn't one).
 
Trish said:
I think I might write to the company and the clinic to ask for a copy of their research protocol and ethics approval for this pilot intervention. (I bet there isn't one).
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I wanted to write to the clinic to ask for this information, but there wasn't a direct email address for the clinic so I've sent it as and FOI request.

I copied this to the organisation that is organising these projects - the West of England Academic Health Science Network, with some explanation of why I'm interested. Another thing I asked about what what training the company mentors will have so they understand that for ME, the aim is pacing, not increasing activity.

Don't suppose I'll get any satisfactory answers.
 
ladycatlover said:
:eek: I couldn't manage one 20 minute telephone conversation. Are they mad? (rhetorical question)
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This seems to he a very common mainstream misconception. That telephone conversations will be more manageable.

It seems to reinforce the feeling that this is really based on fatigue and miles away from ME

It is both sad and concerning that this yet again is the " official" worldview, and that there is such a huge gulf from reality.
 
Andy said:
Still no reply
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Trish said:
I wanted to write to the clinic to ask for this information, but there wasn't a direct email address for the clinic so I've sent it as and FOI request.

I copied this to the organisation that is organising these projects - the West of England Academic Health Science Network, with some explanation of why I'm interested. Another thing I asked about what what training the company mentors will have so they understand that for ME, the aim is pacing, not increasing activity.

Don't suppose I'll get any satisfactory answers.
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I have had a reply from the West of England Academic Health Science Network. They have told me they will be helping the University/Clinic to answer my FOI request to ensure I get the information I asked for.

Here's what I asked for:

1. The research protocol for the pilot project including who is leading it, the ethics committee approval, planned data collection, the planned primary and secondary outcome measures, and method for recording harm.


2. The funding source, amount and breakdown including costs of use of the commercial product and mentors.


3. Details of the planned training for company mentors to ensure their advice does not run counter to current understanding of the limitations on activity possible for people with ME to prevent harm.
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Surely they 'should' already have all that information on hand, as it 'should' all have been needed for the funding proposal and ethical approval.

There should be no need for teams of people, from different institutions, to prepare it, as it should, indeed must, already exist.
 
Wonko said:
Surely they 'should' already have all that information on hand, as it 'should' all have been needed for the funding proposal and ethical approval.

There should be no need for teams of people, from different institutions, to prepare it, as it should, indeed must, already exist.
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I think their point was that I'd asked the University/Clinic for the info, and sent a copy of the request to the West of England network. They reasonably said they didn't want to duplicate the reply, so would cooperate with the University on a single reply.
 
"enrolment materials have not been widely shared to avoid confusion" is puzzling.

Are they a 'secret'?

Or do they think that pwME are collecting vast amounts of protocols, on fatigue studies, every day, and might possibly get confused and mix them up?

TBH the only possible 'justifiable' reason for them not being shared is that 'something' in them could bias the trial if known by the participants.

But withholding such information from participants would surely mean that the participants couldn't give informed consent?

But if they aren't trying to prevent participants from having access to the protocol then why withhold it from those not in their club?
 
KIActiv said:
It is a very easy thing to answer. The project is not a registered clinical trial but rather a real-world evaluation to establish whether the technology benefits the self-management of people with CFS alongside existing care.
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Code: 
https://twitter.com/KiActiv/status/1234482764763799557
 
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