Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Patient Non-Compliance
- Sponsor
- University of Cagliari
- Enrollment
- 112
- Locations
- 8
- Primary Endpoint
- Adherence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders, with a high impact on disability and participation. Poor adherence to pharmacotherapy negatively impacts on the course and outcome of PSS.
Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of relapse and readmission up to 5-time higher than in adherent patients. Falloon et al. developed a Psychoeducation Program (FPP) aimed at improving communication and problem-solving abilities in patients and their families. Past studies reported a statistically significant reduction of the risk of relapse in patients receiving the FPP, but did not take into account effects on adherence.
Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another group exposed to a treatment with generic informative prospects on the disorders provided with same attendance frequency as the FPP (Generic Treatment - GT).
Methods: 340 patients with PSS, from 10 participating units distributed in the territory of the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and concurrently with the administration of a 4-item interview, based on a modified version of the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method, followed by Log-rank test, defining as terminal events both the start of non-adherence and/or the first relapse or readmission episode. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate missing data.
Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already in contact with a psychiatric service is 47%; effect size of psychosocial treatment on various outcomes, including relapse, readmission and adherence to drug is 0.48 of the standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce a change in the prevalence of non-adherence to drug in the exposed group with an effect size of 0.45 SD.
Investigators
donatella rita petretto
Assistant Professor
University of Cagliari
Eligibility Criteria
Inclusion Criteria
- •diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;
- •being in care for 2 years or more.
Exclusion Criteria
- •mental retardation, or any severe cognitive impairment;
- •psychosis due to substance abuse or to a medical condition;
- •affective psychosis;
- •comorbid substance dependence;
- •patient does not understand Italian language;
- •pharmacotherapy with depot.
Outcomes
Primary Outcomes
Adherence
Time Frame: Change from baseline in adherence to treatment at 6 months
Adherence will be checked with a triple method of assessment: patient's self-report, patient's replies to a four-query interview, and assessment of blood levels of the prescribed drug.
Secondary Outcomes
- Readmission(Occurrence of episodes of readmission over 27 months)
- Changes in the social functioning(Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months)
- Psychotic symptoms(Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months)
- General level of psychopathology(Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months)