The Compliance Project Concerning People With Schizophrenia

June 23, 2011 updated by: Ministry of the Interior and Health, Denmark

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000 C
        • Department of psychiatry, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Clinical Risk Managing in Handling Compliance Problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compliance assessed on a compliance-scale
Time Frame: follow-up time 6 months
follow-up time 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of the Interior and Health, Denmark

Investigators

  • Study Director: Bent Nielsen, Ph. D., University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIH, Denmark

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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