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

NCT07352254 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-21

No results posted yet for this study

Summary

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

  • ME/CFS

Interventions

OTHER

online visit

monthly online visits

OTHER

No Interventions

No Interventions

Sponsors & Collaborators

  • Bundesministerium für Gesundheit, Familie und Jugend

    collaborator UNKNOWN

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Meike Dirks, MD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352254 on ClinicalTrials.gov