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IT-based relapse monitoring for schizophrenia

IT-based relapse monitoring for schizophrenia - ILIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034991
Enrollment
110
Registered
2024-08-30
Start date
2024-09-17
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

F20 / F25 according to ICD10 F20 F25

Interventions

Group 1: Experimental group: Weekly monitoring of 10 early warning signs of relapse using the Early Warning Sign Questionnaire (EWSQ-10P) via a CE-certified smartphone app for an intervention period o

Sponsors

Klinikum rechts der Isar, Klinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients of any gender above the age of 18, at the time of inclusion in outpatient treatment in one of the participating outpatient clinics (Inclusion possible from the end of inpatient treatment), primary diagnosis of schizophrenia or schizoaffective disorder (ICD-10 F20/F25) - Maximal markedly ill (CGI and PANNS-6 positive symptoms =5) - At least 1 relapse within the last 2 years before the start of the study (Definition of relapse: Hospitalization or a clinically significant increase in psychotic symptoms; An exception are patients after a first episode whose illness first occurred less than 3 years ago) - Ability to give informed consent, written and spoken German language skills sufficient for participation in the study, - Smartphone ownership that fulfils the minimum technical requirements - Sufficient skills to use a smartphone app regularly

Exclusion criteria

Exclusion criteria: - Acute exacerbation at the time of study enrolment (as determined by a minimum of four weeks of clinical stability, based on the judgment of the treating clinician, with no adjustments to antipsychotic medication dosage during this period) - Cognitive or physical impairment preventing participation in the study (eg, app usage, study visits, completion of questionnaires) - Dementia or mental retardation

Design outcomes

Primary

MeasureTime frame
Re-hospitalization (yes/no) Hospitalization is defined as an increased level of care, including an inpatient stay of at least one day, a day patient stay, or home treatment due to exacerbation of psychiatric symptoms (not social reasons).

Secondary

MeasureTime frame
Parameters of rehospitalization; Attitudes on eHealth; Changes in Shared-Decision-Making, Patient Activation, Patient Satisfaction and Medication Adherence; Symptom Severity; Fear of Recurrence; Social Functioning; Quality of Life, Medical Side Effects; Ressource Consumption; Qualitative interview data (interviews, doctor-patient dyads)

Countries

Germany

Contacts

Public ContactSelina Anna-Maria Hiller

Klinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar

selina.hiller@tum.de+49 89 4140 6430

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026