The mPIVAS study: efficacy of PSYLOG application in monitoring of antipsychotics side-effects

Objectives: The mPIVAS study is designed to assess efficacy of Android smart-phone application PsyLOG in monitoring and controlling side-effects of antipsychotics (SEA). Background and aims: Monitoring of SEA is often subjective, depending on ad-hoc reporting from patients (and their care- givers) and frequently leads to prolonged duration of SEA and possible therapy discontinuation. We constructed this randomized control trial aiming to test the use of mobile technology in improvement of monitoring of SEA. Materials and methods: Patients diagnosed with schizophrenia spectrum disorder treated with antipsychotics for up to five years will be recruited from five Croatian psychiatric hospitals and randomized to three groups differentiated by SEA monitoring method: PsyLOG application, GASS questionnaire and standard monitoring. Additional assessment will include questionnaires for therapeutic alliance and quality of life. During the three-month follow-up period, participants will be assessed after one and after three months from baseline. Results: We plan to recruit 65 patients per group (80% power with expected ≤15% of drop out and missing data). We plan to analyze the differences between three groups in the proportion of patients whose antipsychotic treatment was modified in any way due to side effects and the median time for it, changes in therapeutic alliance and patients’ quality of life. Conclusions: Identifying effective measures for monitoring of SEA could contribute to patients’ health, quality of life and adherence by improving their knowledge about pharmacotherapy, recognition of side-effects and involvement in their treatment, as well as to help clinicians in choosing more appropriate medications.