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The Compliance Project Concerning People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00497848
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment
Schizophrenia Behavioral: motivational interviewing Other: The System-Orientated Intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
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
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ]

Secondary Outcome Measures :
  1. assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Denmark
Department of psychiatry, Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Ministry of the Interior and Health, Denmark
Investigators
Study Director: Bent Nielsen, Ph. D. University of Southern Denmark
More Information

Responsible Party: MD, PhD Bent Nielsen, Department of Psychiatry, Odense, Denmark
ClinicalTrials.gov Identifier: NCT00497848     History of Changes
Other Study ID Numbers: MIH, Denmark
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: July 2007

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders