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Integrated Multiprofessional Primary Care based Model for Moderate to Severely Affected Patients with Post-Acute Infection Syndrome (PAIS)

Integrated Multiprofessional Primary Care based Model for Moderate to Severely Affected Patients with Post-Acute Infection Syndrome (PAIS) - INCAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039230
Enrollment
3000
Registered
2026-03-05
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1: The project is a multicenter, prospective care study at the university hospitals of Tübingen, Freiburg, Ulm, and Heidelberg. The study design follows the Hybrid III approach according to Curr

Sponsors

Insitut für Allgemeinmedizin und interprofessionelle Versorgung, Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (Suspected) post-acute infection syndrome (e.g., PCS, ME/CFS, post-VAC); Duration of illness of at least 6 months; Functional limitations with a PCFS score = 3; Residence in Baden-Württemberg or a district bordering BW; Capacity to consent and consent to participate in the study; Insurance under statutory health insurance;

Exclusion criteria

Exclusion criteria: Inability to visit a SPVP OR attend a video consultation;

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in perceived quality of care and symptom severity. Perceived quality of care is assessed using the PACIC-S (Patient Assessment of Chronic Illness Care – Short Form) and is measured at study entry/baseline (T0), after 3 months or at the last CCM contact (T1), and at 12 months (T3). Symptom severity is assessed using the PCS score (Post-COVID Syndrome Score) and is measured at baseline (T0) and at 12 months (T3). Change is defined as the difference in total scores between the respective assessment time points (PACIC-S: T0–T1 and T0–T3; PCS: T0–T3).

Secondary

MeasureTime frame
Secondary endpoints include health-related quality of life assessed with the EQ-5D-5L (EuroQol 5-Dimension, 5-Level), self-efficacy measured using the SES6G (Self-Efficacy for Managing Chronic Disease—6-Item Scale), recovery following illness assessed with the Recovery measure, and functional impairment measured with the Bell Score (Bell Disability Scale). All secondary endpoints are assessed at each measurement time point: baseline (T0), after 3 months or at the last CCM contact (T1), after 6 months (T2), and after 12 months (T3).

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026