Open [Hanover, Germany] OutreAch MediCal Care for HousEbound Patients With Post-COVID Syndrome or ME/CFS of Any Cause (ACCESS)

forestglip

forestglip

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OutreAch MediCal Care for HousEbound Patients With Post-COVID Syndrome or ME/CFS of Any Cause (ACCESS)

Start of Description
"Based on own clinical experience the grant applicants notice a deficit in the current medical care for patients with Post-COVID Syndrome as well as patients with ME/CFS of other causes, who are unable to leave their home -some of them even bedridden - due to extreme fatigue and exhaustibility.Therefore, we developed a multi-disciplinary project focussed on the assessment of prevalence and special needs of this patient group, that - in case of a positive evaluation - can easily be transferred into routine medical care.

The planned project aims are:"

I copied the headings for the aims of the project. Each of these has a paragraph on the protocol page.
  1. to characterize the main clinical symptoms of the extreme PCS or ME/CFS variant
  2. to detect and describe PCS/ME/CFS mimics in this group of patients
  3. to identify possible risk factors for the development of the extreme PCS or ME/CFS variant
  4. to assess the impact of the moderate to very severe ME/CFS or PCS upon the patients' daily living activities (ADL) and their health-related quality of life (HRQoL)
  5. to assess the caregiver burden associated with the patients' 24/7 need for support
  6. to develop individual care and treatment plans for every patient
  7. to evaluate the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden in a randomized controlled trial
"For the assessment of long-term effects a further online follow-up will be performed 24 months after randomization."

Inclusion Criteria
ME/CFS according to the Canadian Consensus Criteria Bell Score ≤ 30 Duration of the postexertional malaise (PEM) > 14 hours Age > 18 years and < 70

Exclusion Criteria:
Pre-existing conditions or comorbidities that have (or could have) led to a restriction of mobility or mental capacity, such as various diseases of the central nervous system.

Enrollment (Estimated)
100

Sponsor
Hannover Medical School

ClinicalTrials.gov: NCT07352254
 
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to characterize the main clinical symptoms of the extreme PCS or ME/CFS variant
  • via standardized anamnesis and physical and mental assessment by specialists in internal medicine, neurology and psychosomatic medicine performed at separate home visits of the patients. In addition to the patients also the caregivers will be interviewed in standardized manner regarding symptom onset and development.
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I think they will find that this is completely inappropriate for the more severely affected.
to detect and describe PCS/ME/CFS mimics in this group of patients
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What is that supposed to mean? They say they will go through their health records, that sounds awfully invasive and very prone to bias towards psychologisation.
to assess the impact of the moderate to very severe ME/CFS or PCS upon the patients' daily living activities (ADL) and their health-related quality of life (HRQoL)

- via the self-report questionnaires Functional Independence Measure (FIM) (9), a weighted activity score developed for ME/CFS patients for ADL (10) and SF-36 for HRQoL (11)
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How have they managed to not include FUNCAP or any objective measurements like step count?
The effect of the extensive care shall be evaluated by self-report ques-tionnaires of physical and mental health related quality of life (SF36), ADL and caregiver burden in both groups 3, 6, 9 and 12 months after randomization.
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Of course there will only be subjective outcomes.

And why would you include rehab people? Or psychosomatic people?

This is not very encouraging.
 
forestglip said:
OutreAch MediCal Care for HousEbound Patients With Post-COVID Syndrome or ME/CFS of Any Cause

Start of Description
"Based on own clinical experience the grant applicants notice a deficit in the current medical care for patients with Post-COVID Syndrome as well as patients with ME/CFS of other causes, who are unable to leave their home -some of them even bedridden - due to extreme fatigue and exhaustibility.Therefore, we developed a multi-disciplinary project focussed on the assessment of prevalence and special needs of this patient group, that - in case of a positive evaluation - can easily be transferred into routine medical care.

The planned project aims are:"

I copied the headings for the aims of the project. Each of these has a paragraph on the protocol page.
  1. to characterize the main clinical symptoms of the extreme PCS or ME/CFS variant
  2. to detect and describe PCS/ME/CFS mimics in this group of patients
  3. to identify possible risk factors for the development of the extreme PCS or ME/CFS variant
  4. to assess the impact of the moderate to very severe ME/CFS or PCS upon the patients' daily living activities (ADL) and their health-related quality of life (HRQoL)
  5. to assess the caregiver burden associated with the patients' 24/7 need for support
  6. to develop individual care and treatment plans for every patient
  7. to evaluate the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden in a randomized controlled trial
"For the assessment of long-term effects a further online follow-up will be performed 24 months after randomization."

Inclusion Criteria
ME/CFS according to the Canadian Consensus Criteria Bell Score ≤ 30 Duration of the postexertional malaise (PEM) > 14 hours Age > 18 years and < 70

Exclusion Criteria:
Pre-existing conditions or comorbidities that have (or could have) led to a restriction of mobility or mental capacity, such as various diseases of the central nervous system.

Enrollment (Estimated)
100

Sponsor
Hannover Medical School

ClinicalTrials.gov: NCT07352254
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Maybe it is more obvious when in German (I don't have it in me to do the translate and see if the letters spell a word)

But my first question is what with the random capitals? ....which remind me of one of those notes left where letters have been cut out of different magazines etc. or a psychology test where the use of random caps interrupts the normal ability to scan and recognise words by shape.
 
forestglip said:
I added the acronym they wanted to make, ACCESS, to the thread title.

OutreAch MediCal Care for HousEbound Patients With Post-COVID Syndrome or ME/CFS of Any Cause
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Oh the irony

they were so keen to spell out 'access' which I assume should infer it is keen on accessibility that they did this - although I'm open to the possibility in its original language maybe those letters weren't in the middle of the words but made things more like Titlecase?
 
“… can easily be transferred into routine medical care.”

They’ve got a shock coming when they realise just how careful they need to be and how time consuming it is to even enter the room when someone is severe/vs.

At my worst it took 5 hours to simply wake up and turn me over. Even now a minute conversation can be strung out for ages as sometimes I can’t speak or have to keep stopping and resting for very short sentences. I can’t even have things that are shiny in my eyeline as it’s too much sometimes. They may not be allowed access if they wear anything even remotely scented because it can crash people. And then there’s seizures, paralysis… all the things that they will learn if anyone trusts them enough to engage with them.

It drives me nuts when people approach ME like this, but perhaps it will humble them enough to actually think again and do it properly. I just hope they don’t end up sectioning people because they don’t know what else to do and can’t face not having the answer.

(Sorry, think this irked me more than I realised!!)
 
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