post acute infection syndrome U09.9 G93.30
Conditions
Interventions
Group 1: Intervention 1 – A predominantly outreach-oriented biopsychosocial support program accompanying medical care and psychosocial support: Implementation and evaluation of Intervention 1 in (n =
Sponsors
Universitätsklinikum Heidelberg - Abteilung Allgemeinmedizin und Versorgungsforschung
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Intervention 1: Patients with either a confirmed diagnosis or a physician’s suspicion of post-acute infection syndrome, as assessed by a primary care physician or another specialist, and severe functional impairment (Bell Score 20 km and = 100 km, sufficient knowledge in German Interviews for the process evaluation: Patient interviews: Patients with post-acute infection syndromes who participated in either Intervention 1 or Intervention 2; sufficient German language proficiency; age = 18 years and = 60 years; capacity to provide informed consent. Caregiver interviews: Individuals who, as caregivers of participating patients, were involved in supporting and/or accompanying the implementation of Intervention 1 or Intervention 2; sufficient German language proficiency; capacity to provide informed consent; minimum age of 18 years. Healthcare provider interviews: Healthcare providers who, as members of the study team, were involved in the delivery of Interventions 1 and 2; sufficient German language proficiency; capacity to provide informed consent; minimum age of 18 years.
Exclusion criteria
Exclusion criteria: Intervention 1 & 2: Inability to provide informed consent, insufficient knowledge in the German, pregnancy, breastfeeding, severe somatic illness that could sufficiently explain the specified functional impairments (e.g., severe heart failure, end-stage cancer, multiple sclerosis, end-stage renal failure), acute psychiatric disorder requiring immediate treatment (e.g., delusional disorder, acute suicidality) Exclusion criteria for process evaluation interviews: Patient interviews: Age 60 years; lack of capacity to provide informed consent; insufficient German language proficiency; acute psychiatric conditions requiring treatment (e.g., delusional disorder, acute suicidality). Caregiver and healthcare provider interviews: Age < 18 years; lack of capacity to provide informed consent; insufficient German language proficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the interventions (Interventions 1 and 2) is assessed using ten operationalized progression criteria with predefined cut-offs, embedded within a traffic light system. The progression criteria are categorized according to the intervention design and the evaluation design. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Preliminary assessment of the effectiveness of Intervention 1 and Intervention 2: The extent to which health-related quality of life and functional limitations improve among patients who have undergone Intervention 1 or Intervention 2 will be examined. To this end, EQ-5D-5L data will be analyzed descriptively, and exploratory mean comparisons between measurement time points (T0, T1) will be conducted. 2. Further evaluation of preliminary effectiveness: Preliminary effectiveness will additionally be evaluated using various outcome measures with regard to potential moderator variables from the following domains: somatic, psychological, social, caregiver-related, and activity-related factors. In addition, contextual factors will be considered. The following psychometric scales will be analyzed: PHQ-2, GAD-2, PCQ-2, SOCL9, AEQ-F, FACIT-FS, DSQ-PEM, Bell Score, and a provider questionnaire. Wearable-derived data will be analyzed cross-sectionally (T0, T1). App data will be analyzed descriptively and qualitatively. After completion of both data collection periods, quantitative data will be subjected to exploratory mean comparisons. 3. Feasibility of the evaluation: An exploratory assessment will investigate whether the study design is suitable for patients and their caregivers. 4. Process evaluation: The process evaluation will address the following aspects: intervention fidelity; barriers and facilitators to implementation from the perspectives of patients, caregivers, and healthcare providers; acceptance of and satisfaction with the new model of care among patients, caregivers, and providers; perceived mechanisms of action and effects of the new model of care; and unanticipated positive and negative effects from the perspectives of patients, caregivers, and providers. The process evaluation will follow a mixed-methods design, using semi-structured interviews with participating patients, their caregivers, and the treatment team (regarding experiences and perspectiv | — |
Countries
Germany
Contacts
Public ContactLena Krämer
Universitätsklinikum Heidelberg - Abteilung Allgemeinmedizin und Versorgungsforschung
Outcome results
None listed