The Compliance Project Concerning People With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Ministry of the Interior and Health, Denmark
ClinicalTrials.gov Identifier:
NCT00497848
First received: July 6, 2007
Last updated: June 23, 2011
Last verified: July 2007

July 6, 2007
June 23, 2011
May 2007
July 2009   (final data collection date for primary outcome measure)
compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ] [ Designated as safety issue: Yes ]
compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ]
Complete list of historical versions of study NCT00497848 on ClinicalTrials.gov Archive Site
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. [ Time Frame: 6 months ]
Not Provided
Not Provided
 
The Compliance Project Concerning People With Schizophrenia
Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Schizophrenia
  • 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
  • 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
  • Active Comparator: motivational interviewing
    Intervention: Behavioral: motivational interviewing
  • Experimental: The System Orientated Intervention
    Intervention: Other: The System-Orientated Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
23 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00497848
MIH, Denmark
Yes
MD, PhD Bent Nielsen, Department of Psychiatry, Odense, Denmark
Ministry of the Interior and Health, Denmark
Not Provided
Study Director: Bent Nielsen, Ph. D. University of Southern Denmark
Ministry of the Interior and Health, Denmark
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP