post-akute infection syndrome U09.9 G93.3 R53.0
Conditions
Interventions
Group 1: Intervention group receives the basic intervention (I) and the complex intervention (II-IV) in addition to standard care
n = 152 general practices
n = 380 patients
Patient enrollment takes place over a period of 9 months.
Basic intervention:
- Intervention component I – Tailored patient information: Access to evidence-based, digitally provided
supra-regional, interprofessional online quality circles (24 online quality circles over 24 months). Target group: General practitioners as well as occupational therapists, physiotherapists, and psych
n = 253 patients
Basic intervention:
Intervention component I – Tailored patient information: Access to evidence-based, digitally provided patient information designed to promote health literacy, sel
Sponsors
Universitätsklinikum Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Requirement for participation in the study for all participants is the ability to provide independent informed consent, as well as proficiency in spoken and written German. patients: • Minimum age of 18 years • Symptoms that began in temporal association with a clinical infection • Symptoms that have persisted for at least 3 months • Fatigue is present as a symptom • Classified as (suspected) PAIS based on the general practitioner’s initial diagnosis • Registered with a general practitioner at the participating practice • Covered by statutory health insurance • Access to an internet-enabled device primary care practices: • Primary care practice licensed to bill health insurance in Baden-Württemberg, or neighboring regions in Germany if applicable • Willingness and ability to use telemedicine physical and occupational Therapists: • Practicing as a physical or occupational therapist with a license to provide therapeutic services under §124 SGB V in Baden-Württemberg, or neighboring regions in Germany where applicable • Willingness and ability to use telemedicine • Minimum age of 18 psychotherapists: • Practicing as a psychotherapist with approval to bill health insurance in Baden-Württemberg, or possibly neighboring regions in Germany • Willingness and ability to use telemedicine other healthcare providers: • Healthcare professionals providing outpatient and/or inpatient care to PAIS patients in Baden-Württemberg, and possibly neighboring regions in Germany • Willingness and ability to use telemedicine • Minimum age of 18
Exclusion criteria
Exclusion criteria: patients: • Lack of patient consent • Symptoms can be largely or entirely explained by another medical condition • Individuals aged 100 or older primary care practices: • Participation as a primary care practice specializing in the project INCAP —Integrated Multiprofessional Primary Care based Model for Severely Affected Patients with Post Infection Syndrome (funded by the Federal Ministry of Health) physical and occupational therapists: N/A psychotherapists: N/A other healthcare providers: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Reduction of fatigue-related limitations from the patient's perspective WHEN: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months) HOW: Using the FACIT-Fatigue Scale (assessment of the experience and impact of fatigue) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported assessments: - Experience and impact of fatigue using FACIT-FS subscales (T0–T3) - Patient-reported outcomes (pain, sleep, cognition, anxiety and depression associated with PAIS, physical functioning) using PROMIS short forms (T0–T3) - Functional capacity using FUNCAP27 (T0–T3) - Health-related quality of life using EQ-5D-5L (T0–T3) - Work ability compared to the period prior to PAIS onset using an 11-point scale (T0–T3) - Personal recovery using a 5-point Likert scale (T0, T3) - Complaints related to study participation (ongoing, and additionally at T1, T2, T3) data collected at the GP level: - Documentation of 1-minute sit-to-stand test results (in the absence of contraindications) (T0, T3) - Clinician adherence (changes in diagnosis and testing during the study; PAIS, PEM, ME/CFS, PoTS, orthostatic hypotension/tachycardia [unspecified], depression and anxiety associated with PAIS) (T0, T3) - Change in patient health status (work ability, personal recovery via 5-point Likert scales) (T3) - Adverse events related to the study; serious adverse events (SAEs) (ongoing, additionally at T1, T2, T3) In addition, a process evaluation and a health economic evaluation will be conducted alongside the study. Furthermore, routine data from AOK Baden-Württemberg and evaluation results from KVBW will be included in the analyses. | — |
Countries
Germany
Contacts
Public ContactElena Biehler
Universitätsklinikum Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung
Outcome results
None listed