The Compliance Project Concerning People With Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment

Detailed Description
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50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills. The individual intervention is based on Motivational Interviewing by Miller and Concordance Strategies by R. Gray.It is a cognitive behavioral therapy. The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.

Official Title
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Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: motivational interviewing
* Other: The System-Orientated Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnoses of schizophrenia or schizoaffective psychosis 23 years or more Ethnic dane Living in the city of Odense. Exclusion Criteria: not subject to legal action

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: motivational interviewing<br> | Behavioral: motivational interviewing<br>* An individual intervention building on the Motivational Interviewing by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy<br>* Other names: compliance therapy;|
| Experimental: The System Orientated Intervention<br> | Other: The System-Orientated Intervention<br>* Principles in this intervention come from Clinical Risk Managing and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on.<br>* Other names: Clinical Risk Managing in Handling Compliance Problems;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance assessed on a compliance-scale |  | follow-up time 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. |  | 6 months |