The Compliance Project Concerning People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497848
• Other study ID #: MIH, Denmark
• Status: Completed
• Phase: N/A
• First received: July 6, 2007
• Last updated: June 23, 2011
• Start date: May 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2007
• Source: Ministry of the Interior and Health, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• 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

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of psychiatry, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance assessed on a compliance-scale		follow-up time 6 months	Yes
Secondary	assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.		6 months	Yes