BACKGROUND: Despite the proven efficacy of antipsychotics in relapse prevention in schizophrenia and schizoaffective disorder, every third patient experiences a relapse within less than one year. Relapses can worsen psychosocial and treatment related outcomes and lead to substantial economic costs, primarily due to frequent and prolonged hospitalizations. The aim of this project is to evaluate a smartphone- and web-based digital solution for detecting early warning signs of schizophrenia and schizoaffective disorder to reduce relapses and subsequent hospitalizations. METHODS: This randomized controlled trial compares the add-on use of a smartphone-based app for monitoring relapse warning signs in patients with schizophrenia and schizoaffective disorders (ICD-10 F20/F25) used within the routine psychiatric outpatient treatment against treatment as usual (TAU) without any further study-related intervention. Patients in the intervention group use the app for one year, fill in the weekly ten-item Early Warning Signs Questionnaire (EWSQ-10P) and obtain in-app feedback. Clinicians can access the symptom trajectory via a browser-accessible dashboard. If a threshold is exceeded in the inbuilt automatic algorithm, an alert is sent to both, the clinician and patient, enabling timely contact and, as part of a shared decision-making process, an optional adjustment of treatment decision. A total of 110 outpatients are recruited across eight study sites. DISCUSSION: Continuous monitoring of early warning signs is expected to lead to behavioral changes and to decrease the necessity and duration of psychiatric hospital stays, thereby lowering healthcare costs. Additionally, the intervention could reduce symptom severity, alleviate medication adherence, shared decision-making, patient activation or quality of life. Qualitative data is collected to better understand patient needs and preferences regarding app usage and relapses. Insights gained from this study can be integrated into routine psychiatric care, improving the long-term treatment of patients with schizophrenia or schizoaffective disorder. TRIAL REGISTRATION: German Clinical Trials Register (ID: DRKS00034991; registration date: 30.08.2024).

• Keywords
• App, Digital monitoring, Outpatient treatment, Relapse, Schizophrenia, Shared-decision making,
• Publication type
• Journal Article MeSH

AIMS: Decreasing a number of hospital admissions is important for improving outcomes for people with schizophrenia. The Information Technology Aided Relapse Prevention Programme in Schizophrenia (ITAREPS) programme enables early pharmacological intervention in psychosis by identification of prodromal symptoms of relapse using home telemonitoring via a phone-to-PC SMS platform. METHODS: This study was a 1-year extension of a previously published mirror-design follow-up evaluation of programme clinical effectiveness. In total, 73 patients with psychotic illness (45 patients from original sample and 28 newly added subjects) collaborating with 56 family members participated in the clinical evaluation. RESULTS: There was a statistically significant 77% decrease in the number of hospitalisations during the mean 396.8 +/- 249.4 days of participation in ITAREPS, compared with the same time period before participation in ITAREPS (Wilcoxon-signed ranks test, p < 0.00001), as well as significantly reduced number of hospitalisation days when in the ITAREPS (2365 hospitalisation days before and 991 days after ITAREPS enrolment respectively, Wilcoxon-signed ranks test, p < 0.003). CONCLUSION: The ITAREPS programme represents an effective tool in the long-term treatment of patients with psychotic disorders.

• MeSH
• Adult MeSH
• Hospitalization statistics & numerical data   MeSH
• Medical Informatics methods   MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Schizophrenia prevention & control   MeSH
• Secondary Prevention MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH