Protocol Tailored Individual Follow-Ups Versus a One-Day Group Course in Patients With Long COVID Post– COVID-19 Condition: Protocol for [an RCT], 2026,Wilson+

SNT Gatchaman

SNT Gatchaman

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Tailored Individual Follow-Ups Versus a One-Day Group Course in Patients With Long COVID Post– COVID-19 Condition: Protocol for a Randomized Controlled Trial

BACKGROUND
The high prevalence of patients with post COVID -19 condition, also called long COVID, even among those with mild initial disease, may have a large impact on both the individual and society. Disability in everyday life, reduced health-related quality of life and work capacity, strain on the healthcare system and substantial socioeconomic costs are associated with long COVID. More research to investigate the effectiveness of rehabilitation services is warranted.

OBJECTIVE
The purpose of this study is to examine the effectiveness of tailored individual follow-ups versus a one-day group course in patients with long COVID. Additionally, the feasibility and utility of a mobile application for self-monitoring goal achievement will be assessed.

METHODS
This is a single-center, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 62 outpatients aged 18–65 years with long COVID will be randomized to either a rehabilitation program with individual follow-up consultations or a one-day self-management group course. The individual intervention incorporates setting goals, teaching cognitive-behavioral strategies, energy management (pacing), and a supervised gradual increase in both physical and cognitive activities tailored to individual tolerance levels. The primary outcome is the between-group difference in health-related quality of life, measured using the EQ-5D-5L-index at 6 months. Secondary outcomes include improvements in symptoms, work participation, neurocognitive function, and app usability, assessed at 3-, 6-, and 12 months depending on the outcome measure.

RESULTS
Data enrolment started in October 2023. A total of 62 participants were included by November 2024. Data collection is planned to be completed in November 2025.

CONCLUSIONS
Long COVID poses significant challenges for both individuals and society, underscoring the need for effective rehabilitation strategies. This study will provide valuable insights into the benefits of an individualized outpatient rehabilitation program. The results from this clinical trial will help guide future treatment recommendations and may improve long-term outcomes for affected patients. Additionally, the study will generate important knowledge about neuropsychological function and digital self-management tools in long COVID rehabilitation. Clinical Trial: ClinicalTrials.gov NCT06085911; https://www.clinicaltrials.gov/study/NCT06085911

Web | DOI | PDF | JMIR Research Protocols | Open Access
 
"One Battle After Another"

Standard Treatment: One-Day Group Course

Standard treatment at UNN is a one-day multidisciplinary group course. The duration is 6 hours, including breaks. Each group consists of 8 to 10 participants. The aim of the course is to improve self-management of long COVID. The course provides education about (1) sustaining factors of long COVID based on elements from a CBT framework, (2) activity regulation, (3) the importance of daily routines, and the advantages of both (4) physical and (5) cognitive exercise. Information is provided by a doctor, a psychologist, and an occupational therapist or a physiotherapist. Exchange of experience between participants is also facilitated. No follow-up consultations are provided. Information about the mobile app supplement is offered; a mobile app called My COVID Rehabilitation. The participants can voluntarily download the mobile app as a supplement, and personal goals can be noted and adjusted.
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Study Intervention

The intervention in this study is delivered individually by a physiotherapist following the study instructions described in Textbox 1. The physiotherapist may consult the multidisciplinary team if necessary. The intervention begins with a physical consultation where symptoms, function in everyday life, sustaining factors, and resources are thoroughly assessed. Education about long COVID based on elements from a CBT framework [18] is provided. Tailored to the participant’s life, a personalized rehabilitation plan is created, consisting of home-based exercises to facilitate a combination of pacing and graded escalation of physical and cognitive activities. The home-based exercises have 3 focus areas: daily routine, physical activity, and cognitive training. The plan consists of weekly personal goals to guide the participant’s progress. Three video-follow-up consultations are given to support change and to encourage participants to adjust personal goals in step with recovery within the 3 focus areas. Supported by the physiotherapist, the personalized goal setting is then verbalized and adjusted during the follow-up consultations. In total, 4 consultations are given within 6‐8 weeks. Voluntarily, the participants can download the My COVID Rehabilitation mobile app as a supplement, where the goals can be noted and adjusted.
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Sigh. And of course essentially all subjective outcomes, which will no doubt be biased by the considerably increased contact offered by the intervention vs standard "care". Objective secondary outcome data includes self-reported absence from work (yes/no and percentage absence) and self-reported healthcare usage; plus memory and executive function testing.
 
Rehab by education, CBT even when not asked for; how about NICE?
6- 8 weeks of education and goal setting and then there is an app to gather information (for the physio's).

But the patients will have to do self-management.

Physio's are paid, insurance does not have to pay that much, government happy.

The patients pay the price.
 
Sigh. It's just an ongoing nightmare.

According to the WHO, patients with long COVID may experience worsening of symptoms following minimalcognitive, physical, emotional, and social activity, or activity that could previously be tolerated [24]. A result of this is often a behavioral challenge where patients exceed their owntolerance limit, followed by complete rest, an all-or-nothing pattern. Others may generally fear activity because it may lead to exacerbation of symptoms, also called fear-avoid-ance. Such patterns are often seen in CFS/ME [25].

Graded fixed incremental exercise therapy is debated in the literature because it might cause PEM, which is associated with poor health outcomes [26-29]. Pacing, on the other hand, is how to balance activities and rest to avoid exacerbation of symptoms, and thus not fixed incremental steps [24]. In patients with long COVID, individualized activity plans with education on pacing should therefore be provided. It is documented as beneficial to gradually introduce activity to restore patients to previous levels of activity, including daily routines [5,30]. Interventions that combine pacing and graded escalation of physical and cognitive activities are called graded activity [25]. A recent review (2023) found graded activity based on elements from CBT to be effective in reducing fatigue and improving physical functioning in CFS/ME [25].

Findings from previous studies indicate that long COVID is a complex condition that can be treated by a graded activity intervention. Daily routines and regular physical and cognitive exercise may be 3 important focus areas in this behavioral management of long COVID.
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Ref #25 is
Casson S, Jones MD, Cassar J, et al. The effectiveness of activity pacing interventions for people with chronic fatigue syndrome: a systematic review and meta-analysis. Disabil Rehabil. Nov 2023;45(23):3788-3802. [doi: 10.1080/ 09638288.2022.2135776] [Medline: 36345726]
Forum thread here - Andrew Lloyd had a hand in it.
 
Kalliope said:
Very disappointed to see Nina Langeland among the authors. She has been researching post infectious illness since an outbreak of giardia in Bergen, Norway in 2004. She was one of the first doctors/researchers to warn against Long Covid.
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Research into the giardia outbreak and fatigue have linkings to COFFI, although I don't know Langelands opinion on them.
 
Cherry picking, both the 'evidence' and the interpretation, par excellence.

Until they start getting held to adequate account for it they will continue right with this appalling dishonesty and expanding their empire.

No sign of that accountability happening yet. To the contrary. They are being increasingly rewarded for it all, and protected from accountability.

Psychosomatics and 'rehabilitation' has thoroughly corrupted modern medicine. Reality simply doesn't matter any more.
 
It seems blindingly obvious to me that anyone who experiences PEM will opt not to participate in this study or will need to adapt their goals to exclude the activity increases. There doesn't seem to be any understanding of PEM, which is dismissed with a brief inadequate description and is not included in any of the questionnaires.

The whole thing is a farce.

I think this demonstrates yet again that the term Long Covid is far too broad to be useful either clinically or in research.
 
Authors that know way too little about LC and ME/CFS should stay miles away from "educating" patients.
A one day group course is too long for most patients anyway, they should have known that.
The idea alone that one day of "education" would be helpful is pure hybris.
Convenient for the therapists and probably harmful to the patients.
As @Eleanor pointed out "Improvements in app usability" maybe the next paper "Educate by app" and LC disappears?
 
Findings from previous studies indicate that long COVID is a complex condition that can be treated by a graded activity intervention. Daily routines and regular physical and cognitive exercise may be 3 important focus areas in this behavioral management of long COVID.
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And yet this has been the standard approach from the start, so there is no "can be" here, we know it doesn't, because if it did work we'd know and LC wouldn't even be a problem. The idea of testing the standard approach and comparing it to a variation of itself is so cynical even I'm maxing out on it. Even Theranos' fraud was so much more legitimate and less obviously fraudulent than this.

This is just complete disconnection from reality. Same as it's ever been. It's impossible to understand how this just goes on and on, no one can legitimately claim they're doing anything different than what's not only been tested thousands of times, but was standard treatment for this type of illnesses on day one of LC. There is no longer any possible claim of passive failure, it's active criminal negligence.

Insanity is the only accurate way of describing this. It looks even more insane than whatever the hell is going on with RFK Jr.
Trish said:
I think this demonstrates yet again that the term Long Covid is far too broad to be useful either clinically or in research.
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LC is mostly fine, it's that fine-graining it into its various parts has failed because those parts have always been rejected and are explicitly discriminated against. There is nothing wrong with the concept of LC, it's medicine's entire mishandling that is wrong here. This is fully intentional failure.
 
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