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 as-sessment 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:

1. 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.

- Patients will be recruited via their family doctors, patient support groups and
social media as well as through our Post-COVID outpatient clinics through calls
we get from housebound patients and their caretakers.

2. to detect and describe PCS/ME/CFS mimics in this group of patients

- via the analysis of all data achieved from home visits as well as the available
data of former diagnostic efforts in cooperation with the responsible family
doctor.

- Our structured care at Outreach Medical Care for ME/CFS patients includes a
thorough evaluation of previous medical findings, where available. Findings
that were made years before the onset of symptoms may also be relevant. These
findings are recorded in a structured form and are included in the evaluation.
Since the electronic health record shall be compiled for every member of a
statutory health insurance until January 2025 previous medical findings should
be more easily available than currently.

3. to identify possible risk factors for the development of the extreme PCS or ME/CFS
variant

- via the comparison of characteristics such as age, sex, BMI, accompanying
diseases, the patients' medical history as well as socio-economic status including
level of education, occupation, household income of the patients recruited into the
planned study to already available data on subjects with a COVID-19 history but no
(n=88) or less severe Post-COVID symptoms (n=115) evaluated at the Department of
Neurology, recently.

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)

- via the self-report questionnaires Functional Independence Measure (FIM), a
weighted activity score developed for ME/CFS patients for ADL and SF-36 for HRQoL.

5. to assess the caregiver burden associated with the patients' 24/7 need for support

- via the Zarit Burden Interview

6. to develop individual care and treatment plans for every patient

- via online discussion of every case in an interdisciplinary board consisting of
the specialists in internal medicine, neurology and psychosomatic medicine, who
have examined the pa-tients during the home visit, the patient's family doctor,
and a team of specialists involved in the care for PCS patients at the PCS
out-patient clinic at Hannover Medical School (a social worker, a general
practitioner and specialists for pulmonology, rheumatology and rehabilita-tion
medicine). This board shall act as a bridge between highly specialised
university medi-cine and primary care.

- Of note, patients will be included into the study only if their caregiver and
their family doctor agree to take part as well.

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 - The primary objective of the randomized controlled trial (RCT) is to compare
extensive vs. non-extensive care of patients and caregivers. In the non-extensive
group patients will be visited at baseline and will receive their individual
treatment plan that is prescribed and mon-itored by their family doctor. In the
extensive care group patients and caregivers will receive extensive support for the
realization of the treatment plan by the ACCESS study team includ-ing the
opportunity for online consultations held by one specialist of the three involved
disci-plines every month. The effect of the extensive care shall be evaluated by
self-report questionnaires 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. Moreover, the patients' clinical status shall be assessed 1 year
after randomization via rerun of the examinations performed at baseline during a
home visit.

For the assessment of long-term effects a further online follow-up will be performed 24
months after randomization.