Post-acute infection syndom
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Triggering infection within the last 6 months prior to recruitment - Development of lasting symptoms or complaints within 3 months after the triggering infection - Symptoms or functional limitations lasting for at least 2 months - Patient is using Emails and can understand and answer informed consent and online questionnaires in German language - Patient able to give informed consent - Signed informed consent by patient
Exclusion criteria
Exclusion criteria: - medical conditions that might interfere with the patient’s participation in the study, poses any added risk for the patient, or confound the assessment of the patient - Known pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom burden measured by EQ-5D-5L questionnaire at different time points (difference between EQ-5D-5L) at study inclusion (time 0), month 6, 12, 18, 24, and 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Limitations in functional status as well as health domains using the domains of the EQ-5D-5L questionnaire at study inclusion (time 0), months 6, 12, 18, 24, and 30. - Functional status based on KLOK grade at study inclusion (time 0) and after 6, 12, 18 24, and 30 months. - Perceived satisfaction with medical care using the PSQ-18 questionnaire at baseline (time 0) and and after 6, 12, 18 24, and 30 months. - Description of symptom clusters and functional limitations including incidence and course over the entire duration of the study using the validated PROM questionnaires (SF36, PEM, PHQ4, FSS, POTS, MMQ and mMRC Dysnpnea) - Description of patient pathways (use of various care options within the study, duration and frequency of consultations) - Identification of risk factors and potentially biomarkers for a severe (KLOK grades 3-4, diagnostic criteria for ME/CFS using the Canadian consensus criteria) and/or chronic course (all KLOK grades, persistence of symptoms after 12, 18, 24, and 30 months) as well as for fast recovery: using questionnaires with validated PROMs throughout the study, using proteomic analyses in a subset of 500 patients at inclusion and month 12 - Evaluate the impact of socioeconomic status (SES), subjective social status (SSS), and migration context to evaluate on disease severity, chronicity, recovery, and access to healthcare. SES will be assessed at baseline based on education via (ISCED 2011), income, occupational status via (ISCO-08), and housing conditions. SSS will also be measured at baseline using the validated MacArthur Scale to capture individuals perceived social standing relative to others. Migration context will be determined based on the validated questionnaire of the Improving Health Monitoring in Migrant Populations (IMIRA) study. - Investigate elements of satisfaction with and access to healthcare as reported by the questionnaire of Perceived responsiveness of the healthcare system from the patient's perspective (W | — |
Countries
Germany
Contacts
Charité Universitätsmedizin Berlin