Protocol Take charge after long COVID: a mixed methods randomised controlled pilot study protocol, 2025, Laver et al

rvallee

rvallee

Senior Member (Voting Rights)
Take charge after long COVID: a mixed methods randomised controlled pilot study protocol

Abstract​

Introduction​

Post COVID-19 condition is a debilitating illness with over 200 symptoms across 10 organ systems and is presently impacting millions worldwide. The National Institute for Health and Care Excellence recommends a multidisciplinary treatment approach including person-centred self-management strategies, however evidence for specific programs is lacking. The Take Charge intervention is a person-centred, self-management rehabilitation approach that has been effective in recovery after stroke, but not yet tested in post COVID-19 condition.

Methods & analysis​

A prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Participants will be at least 18 years of age, have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms, and be known to a hospital clinic for assessment and treatment of patients with post-acute sequelae of COVID-19. The primary outcomes are the Modified COVID-19 Yorkshire Rehabilitation Scale and the COVID-19 Core Outcome Measure for Recovery. The secondary outcomes include physical and self-report measures, and feasibility measures. Qualitative interviews will also be conducted to understand the clinicians’ and participants’ experiences. Statistical analysis will be performed on an intention-to-treat basis using a multivariate mixed-effect linear regression model.

Ethics & dissemination​

This study adheres to the Declaration of Helsinki. This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (approval number: 2022/SSA00695/OFR: 219.22, protocol version 3.3 19 February 2024). The results will be disseminated in peer-reviewed journals, conference presentations, and media.
 
This study aims to test an intervention known as Take Charge which aims to promote hope, activity and participation and differs from many forms of ‘standard’ practice [Citation11,Citation12]. It is a short (two sessions) therapeutic intervention that encourages people with chronic health conditions to consider their values, what is important to them, and how they will maximize their quality of life in the coming months. It is designed to de-medicalize a condition, improve intrinsic motivation, and foster the participant to Take Charge of their own recovery [Citation11,Citation12]. Few interventions have been able to achieve this or have required time-intensive programs and extensive training, which Take Charge does not. The intervention was successful in two randomized controlled trials comprising 572 stroke patients, where it was shown to improve quality of life, reduce carer strain, and increase independence up to 12 months post-intervention [Citation11,Citation13]. The intervention is brief, low cost, requires minimal training, and can be delivered face-to-face in a hospital outpatient setting or via telehealth [Citation14]. If successful in post COVID-19 condition, it could make an immeasurable difference to quality of life and global economies.
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Just completely delusional. The same bullshit pseudoscience over and over again. Throw this entire discipline in the trash and melt the trash compactor afterward.
 
Quote;
"It is designed to de-medicalize a condition, improve intrinsic motivation, and foster the participant to Take Charge of their own recovery"

Too bad if it is a medical condition - just tell patients it's not and it's up to them to sort their own recovery. Oh, and blame them for lacking motivation if they don't recover.

How utterly poisonous.

Surely more honest to say, we haven't a clue what's wrong, and all we can advise is rest and pacing. Still the patient taking charge, but with a different perspective.
 
Trish said:
Quote;
"It is designed to de-medicalize a condition, improve intrinsic motivation, and foster the participant to Take Charge of their own recovery"
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Sounds like what I got at rehab six months after covid. It did not turn out very well for me. But they kept using it because some patients did get better while doing it, although I suspect it was more of a natural recovery due to the time frame.
 
They changed it from a study on efficacy to a study on feasibility. Wonder why they moved the goalpost..

They changed the follow up time after they had started the trial, from 3 to 6-12 months.

They changed the objective measures from primary to secondary (they say this was done before participants had «commenced»).

And the «show history» page for anzctr.org.au is complete garbage. Please just do it like clinicaltrials.gov
 
Trish said:
Surely more honest to say, we haven't a clue what's wrong, and all we can advise is rest and pacing. Still the patient taking charge, but with a different perspective.
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One of the most horrifying things about all of this is that most MDs will readily admit they are clueless about it. But we also get this, so we have two mutually exclusive versions of reality competing with one another. No one knows what's actually true unless they spend a lot of time filtering through the BS, and of course that always ends up in the same category as "doing our own research", because that's always said with the assumption of scientific illiteracy and kookiness.

So when pressed for details, most will admit they know nothing. But most will also present this like it's a serious thing.

Competing alternative realities is the hallmark of modern disinformation. It works by discrediting the very notion that truth exists, and that instead everyone lies, or makes stuff up, or tries to take advantage of everyone. It even discredits the notion of reliable expertise, and medical experts just keep giving the conspiracy fantasy communities gift after gift.

And then they wonder why they, especially so, are losing the information war. Good grief we are a ridiculous species.
 
This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (approval number: 2022/SSA00695/OFR: 219.22, protocol version 3.3 19 February 2024).
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The first participant was randomized to the trial on the 22nd of December 2023. Recruitment is ongoing.
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Received 23 September 2024
Revised 28 April 2025
Accepted 13 May 2025
 
Utsikt said:
They had to get a new approval, I’m not quite sure why.
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I've needed a new approval for minor changes in the project description with no real difference for the "ethics" of the study in question.

Such as changing the cut-of date for data collection (the reasons for why the change is done might be relevant, but for us it was just "we've waited so long that there is another year of data available from the registry now and we will just as well apply for it")
 
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