The Compliance Project Concerning People With Schizophrenia

NCT ID: NCT00497848

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-07-31

Brief Summary

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

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

motivational interviewing

Group Type: ACTIVE_COMPARATOR

motivational interviewing

Intervention Type: BEHAVIORAL

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

The System Orientated Intervention

Group Type: EXPERIMENTAL

The System-Orientated Intervention

Intervention Type: OTHER

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.

Interventions

motivational interviewing

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

Intervention Type: BEHAVIORAL

The System-Orientated Intervention

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.

Intervention Type: OTHER

Other Intervention Names

compliance therapy; Clinical Risk Managing in Handling Compliance Problems

Eligibility Criteria

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

• Minimum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Department of Psychiatry, Odense, Denmark

Principal Investigators

Bent Nielsen, Ph. D.

Role: STUDY_DIRECTOR

University of Southern Denmark

Locations

Department of psychiatry, Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

MIH, Denmark

Identifier Type: -

Identifier Source: org_study_id