The Compliance Project Concerning People With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00497848|
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: motivational interviewing Other: The System-Orientated Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
|Active Comparator: motivational interviewing||
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 Name: compliance therapy
|Experimental: The System Orientated Intervention||
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.
Other Name: Clinical Risk Managing in Handling Compliance Problems
- compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ]
- assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497848
|Department of psychiatry, Odense University Hospital|
|Odense, Denmark, 5000 C|
|Study Director:||Bent Nielsen, Ph. D.||University of Southern Denmark|