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

NCT07352254 | Recruiting

• 1 other identifier: 11793-BO-S-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ME/CFS; housebound; house call

Outcome Measures

Primary Outcomes (1)

• Short Form (SF)-36 health survey, physical score

  Short-Form (SF-36) health survey to assess health related quality of life, here the physical score. Higher values indicate better health status. The range depends on age, gender and education.

  1 year

Study Arms (2)

intensified medical care

EXPERIMENTAL

monthly online visit in addition to standard care

Other: online visit

standard care

ACTIVE COMPARATOR

standard care as decided after discussion between family doctor and visiting specialists

Other: No Interventions

Interventions

online visit OTHER

monthly online visits

intensified medical care

No Interventions OTHER

No Interventions

standard care

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Hannover Medical School: lead
• Bundesministerium für Gesundheit, Familie und Jugend: collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Related Publications (5)

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 RESULT

• Braun M, Scholz U, Hornung R, Martin M. The burden of spousal caregiving: a preliminary psychometric evaluation of the German version of the Zarit burden interview. Aging Ment Health. 2010 Mar;14(2):159-67. doi: 10.1080/13607860802459781.

  PMID: 20336547 RESULT

• Morfeld M, Kirchberger I, Bullinger M. SF-36- Fragebogen zum Gesundheitszustand, 2. Auflage, Hogrefe Verlag, 2011

  RESULT

• Sommerfelt K, Schei T, Angelsen A. Severe and Very Severe Myalgic Encephalopathy/Chronic Fatigue Syndrome ME/CFS in Norway: Symptom Burden and Access to Care. J Clin Med. 2023 Feb 13;12(4):1487. doi: 10.3390/jcm12041487.

  PMID: 36836022 RESULT

• Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.

  PMID: 3503663 RESULT

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meike Dirks, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meike Dirks, MD

CONTACT

+495115323145; access-patienten@mh-hannover.de

Karin Weissenborn, Professor

CONTACT

dirks.meike@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Neurology, Principal Investigator

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD and supporting information will be available after final data analysis for ACCESS for at least 10 years
• Access Criteria: Anonymous data will be available for scientific purposes after reasonable request

Locations

DE (1)