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The Compliance Project Concerning People With Schizophrenia

Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497848
Enrollment
70
Registered
2007-07-09
Start date
2007-05-31
Completion date
2009-07-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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

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.

Interventions

BEHAVIORALmotivational 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

OTHERThe 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.

Sponsors

Ministry of the Interior and Health, Denmark
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
23 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
compliance assessed on a compliance-scalefollow-up time 6 months

Secondary

MeasureTime frame
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026