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

History of Changes

Purpose

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	Intervention
Schizophrenia	Behavioral: motivational interviewing Other: The System-Orientated Intervention

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Ministry of the Interior and Health, Denmark:

Primary Outcome Measures:

compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	70
Study Start Date:	May 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	23 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	MD, PhD Bent Nielsen, Department of Psychiatry, Odense, Denmark
ClinicalTrials.gov Identifier:	NCT00497848 History of Changes
Other Study ID Numbers:	MIH, Denmark
Study First Received:	July 6, 2007
Last Updated:	June 23, 2011
Health Authority:	Denmark: The Ministry of the Interior and Health

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

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