Trial Report REFUEL-MS - CBT/GET Digital Intervention MS-Fatigue

Developing, optimising and implementing a blended digital self-management tReatmEnt for FatigUe in multiplE scLerosis (REFUEL-MS)

https://fundingawards.nihr.ac.uk/award/NIHR203290
https://www.refuel-ms.com/

Chief Investigator(s):
Professor Rona Moss-Morris

Co-investigators

Start Date: October 2022 End Date:April 2028

Contracting Organisation:
Guy's and St Thomas' NHS Foundation Trust

Award:
£2,520,098.00

Abstract:

Background: Multiple Sclerosis (MS) is an incurable, neurological disease typically diagnosed in young adults who are faced with a lifetime of relapsing and/or progressive disabling symptoms. Fatigue is the most prevalent symptom and has the largest impact on quality-of-life and early retirement from work. Fatigue in MS is more severe than fatigue in other long-term conditions (LTCs). Medications have little effect on MS-fatigue. Balance and mixed exercise interventions and cognitive-behavioural therapy (CBT) self-management for fatigue show moderate to large end-of-treatment effects. Work is needed to sustain treatment effects over time, including integrating effective treatments to provide patient choice and tailoring for different fatigue mechanisms. Implementing these treatments in NHS setting is key. In the UK, 90% of people with MS (pwMS) experience fatigue. Only 3% have been offered an exercise treatment and 6% a behavioural treatment. The aim of this programme is to draw together existing components of the most promising exercise and behavioural interventions into an individually-tailored physiotherapist/occupational therapist supported digital fatigue treatment (REFUEL-MS), that is clinically and cost-effective, and can be implemented routinely across NHS MS services.

Methods: Aims will be met through interactive and iterative work packages (WPs). WP1 (months 1-18) Development of REFUEL-MS through refining a logic model, building the patient interface using co-design workshops and think-aloud methods with pwMS. Building health care professional (HCP) support package, platform and training through focus groups and think-aloud methods with HCPs. WP2 (in parallel with WP1) Addresses reach through focus groups (N=6) with formal/informal carers of pwMS and pwMS, and individual interviews (N=25-30) with under-served/seldom-heard pwMS. These data will feed into REFUEL-MS to ensure diversity and social care needs/support are addressed.

WP3 (months 12-18) Optimises the functionality and acceptability of REFUEL-MS through mixed methods case-series with a diverse group of pwMS (N=15-20). WP4 (month 18-30) tests the feasibility of and refines the implementation plan through mixed-methods iterative case-series study in four diverse NHS services. WP5 (months 26-60) Hybrid-II stepped-wedge cluster randomised-controlled trial with internal pilot: 12 services randomised to 6 start times of REFUEL-MS delivery (3-months unexposed with treatment-as-usual data collected, 1 month for training of REFUEL-MS facilitators, 5 months exposed with REFUEL-MS delivery and data collection). 576 pwMS recruited (216 unexposed, 360 exposed).

Primary effectiveness outcome: patient-level fatigue severity at 36-weeks post-baseline, primary implementation outcome: NoMAD. Treatment effects estimated using three-level linear mixed-effects models following the intention-to-treat principle (ITT). Cost-utility analysis relating the difference in total mean costs per phase to the difference in quality-adjusted life years.

WP6 (months 60-66) To ensure sustainably, policy labs with key stakeholders to create a policy document on NHS scaling of REFUEL-MS and a business model for long-term sustainability. Workshops with other LTCs communities (patients and HCPs) to develop a template to adapt REFUEL-MS for other LTCs.

Anticipated impact: Transformed standard fatigue care in MS including under-served/seldom-heard groups, implemented in 12-16 services, and scalable and sustainable in other MS NHS services in England. Longer-term impact includes: (1)Adapted and implemented REFUEL-MS for other LTCs, (2)Improved implementation and commissioning of evidence-based digital behavioural products[/URL].

 

The vultures are at it again.

 

Completely absurd. This is pure waste with zero possible benefit.

 

Are MS patient organizations aware of how awful CBT/GET studies are?

 

tReatmEnt for FatigUe in multiplE scLerosis

Reading this hurt my eyes.

The mind boggles about what pwMS must be thinking about it

 

It also hurts my brain. I think it's emblematic of the lack of internal consistency and logic that defines this entire domain. The last two words are literally "multiple sclerosis" and yet they ignore the initial M and S, which are not directly incorporated into the acronym, but instead tacked on at the end. It reads as if they had the "REFUEL" acronym first and were determined to bang the square peg into the round hole of disease X.

 

Honestly, I doubt it. I've noticed over the years patient organizations tend to have this "submissive" vibe where they just assume the researchers know best and never to question anything. They just socialize with each other and raise money for research, I guess.

ME patients had to learn the hard way about being skeptical, because doctors treat us so badly, but even then most patients default to idolizing fringe doctors/researchers instead.
The only people who are skeptical of the research are typically alt med freaks who think metal chelation or herbs is the answer to everything.

Don't let me dissuade you though, maybe it is worth contacting MS orgs.

 

kerching, rise in value of shares in digital therapies.
less money going into research for a cure.

 

Can someone from here contact a UK MECFS organization to see if they will write a formal letter to a UK MS organization with an expression of concern (indicating that this type of BS besets the MECFS research arena and will be a total waste of money)?

If they can write a formal letter and this is made public then the letter could be widely distributed, etc., may put pressure on MS orgs to oppose this.

 

Ironically, since MS is taken seriously and has medical advisers by the truckload, they are probably more likely to OK this from the top without much input from the patients, with most of them assuming that the medical professionals helping them would never OK pseudoscience and so it must be legit.

They have been helped by the system, they don't have reasons to mistrust it. And they have real research and medical care anyway, this is just a sideshow that can be ignored entirely, it won't hinder progress or anything like that. It's still fraudulent waste of public funds but it comes from a different pot.

 

Thanks for the hearty laugh!

LEavE £2,520,098 on tHiS acCOunT foR tReatmEnt for FatigUe in multiplE scLerosis


I don't think I can ever unsee these forced idiotic acronyms like this now.

 

digital self-management treatment for fatigue in multiple sclerosis

daftness

 

Merged thread

MS society:

REFUEL-MS: Can a digital intervention help to improve fatigue in people with MS?
Data from the UK MS Register shows 90% of people with MS experience fatigue. But less than a third of people have been offered treatment for their fatigue as part of their routine care.
Some people with MS find existing drug treatments, like amantadine, help their fatigue. But these don’t work for everyone. They often come with side effects. And some evidence suggests non-drug treatments can actually make a bigger difference to fatigue levels.
So as well as developing better medications for MS fatigue, we need other ways to help people with MS reduce their fatigue.

https://www.mssociety.org.uk/resear...h-our-research-projects/refuel-ms-can-digital