Actively Recruiting

Phase Not Applicable
Age: 18Years - 69Years
All Genders
NCT07352254

OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME/CFS of Any Cause (ACCESS)

Led by Hannover Medical School · Updated on 2026-01-21

100

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

H

Hannover Medical School

Lead Sponsor

B

Bundesministerium für Gesundheit, Familie und Jugend

Collaborating Sponsor

AI-Summary

What this Trial Is About

The significance of the Post-COVID Syndrome (PCS) has been widely acknowledged. Various efforts are made to find out about the pathomechanisms behind PCS and to establish therapies. One sub-group of PCS-patients, however, is generally excluded from any studies, and that are those who are unable to visit outpatient clinics or hospitals for diagnostic work up or participation in clinical trials, as they are unable to leave their home and to seek medical support on their own physical and mental capabilities. They are housebound, mostly or totally bedridden. Similar cases are known from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) of any cause and are graded as moderate to very severe ME/CFS according to the Canadian Consensus criteria. The patients are usually seen by their family doctor and have no access to medical specialists. The planned project aims to find out about the prevalence of this most severe manifestation of PCS, the clinical characteristics, the prevalence of mimics, risk factors and impact of the disease on the patients' life and their family/caregivers. Individual care and treatment plans will be developed and the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden will be evaluated in a randomized controlled trial. The project will be performed in close cooperation between patients, caregivers, the patient's family doctor and a board of experts from internal medicine, neurology, psychosomatic medicine and general medicine at Hannover Medical School. We expect an improvement of the patients' and caregivers wellbeing with intensified medical care. We are aware, however, that intensification of the patient-doctor interaction carries the risk to exacerbate the patients' symptoms. The results of our study will show how current models of care for PCS and ME/CFS patients should be modified to fit to the individual patient's aims and capacities.

CONDITIONS

Official Title

OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME/CFS of Any Cause (ACCESS)

Who Can Participate

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ME/CFS diagnosed according to the Canadian Consensus Criteria
  • Bell Score of 30 or less
  • Postexertional malaise lasting more than 14 hours
  • Age greater than 18 years and less than 70 years
Not Eligible

You will not qualify if you...

  • Pre-existing conditions or comorbidities that limit mobility or mental capacity, such as various diseases of the central nervous system

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hannover Medical School

Hanover, Germany, 30625

Actively Recruiting

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Research Team

M

Meike Dirks, MD

CONTACT

K

Karin Weissenborn, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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