The objective of the study is to investigate whether the application of the multidisciplinary guidelines for the treatment of schizophrenia leads to a better course of schizophrenia and related disorders.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Course of the illness is the primary outcome measure. But "course" is a
composite construct.
Of the measures used in this study, the following are related to course and
thus are primary:
- The number of patients with one or more relapses since the end of the trial
- Number of patients currently in remission (symptoms)
- Number of patients currently recovered (symptoms and functioning)
- Level of socaal functioning
- Quality of Life
- Within the group of successfully discontinued patients: how many are still
discontinued without sustaining any relapse.
Secondary outcome
Use of medication and its relationship with relapses.
Quality of life
Background summary
In 2005 multidisciplinary guidelines were published for the treatment of
schizophrenia. These guidelines were made on the basis of research regarding
efficacious interventions for this disorder. The aim of these guidelines was to
introduce more evidence based interventions in the care for patients suffering
from schizophrenia.
The institutions who participated in MESIFOS are generally at the forefront of
changes in patient care. As an example, during the study more than 90% of the
patients were treated with second-generation antipsychotics for two years,
which is one of he new guidelines.
It is reasonable to assume that the participating institutions applied many of
the guidelines for the treatment of this group of patients. The very thought
behind the guidelines is that their application could lead to a better course
of the disorder.
The present study aims to answer the question whether the intermediate course
(approx. 7 years) of the disorder in patients treated according to these
guidelines is better than that in earlier comparable cohorts, before the
introduction of the guidelines.
Study objective
The objective of the study is to investigate whether the application of the
multidisciplinary guidelines for the treatment of schizophrenia leads to a
better course of schizophrenia and related disorders.
Study design
This study is a naturalistic follow-up of a previous study: MESIFOS. Seven
institutions in seven regions participated in MESIFOS, covering a catchment
area of 3.1 million inhabitants: UMCG (Groningen), GGZ Friesland, GGZ Drenthe,
Adhesie (now called Dimence), Mediant (Enschede), de Grote Rivieren
(Dordrecht), GGnet (Zutphen).
Since this is a follow-up of the same subjects the same instututions will
participate again. The research infrastructure that was built for MESIFOS is
still intact. The GROUP study is using the same infrastructure today. Many of
the research assistants are still active in this study.
After approval of the Medical Ethical Committee the study can begin. The
researcher still have the personal data of the subjects. They consented dduring
the last MESIFOS interview to be contacted again at a later date. The research
assistant will contact the subjects if they do not reply to the invitation to
participate.
If the subject consents to participate, the interview will follow. In the
informed consent there is also a paragraph about the consent to consult the
medical records. The subject can decide to give a partial consent, i.e. for
either of the above.
In case of refusal for personal participation the subject can also give consent
to obtain information from the attending psychiatrist.
Study burden and risks
The repondents will be interviews that have been used in a large number of
studies. No apparent risks have emerged from those studies.
Postbus 30.001
9700RB
Nederland
Postbus 30.001
9700RB
Nederland
Listed location countries
Age
Inclusion criteria
Participation in the MESIFOS trial
Exclusion criteria
Not applicable
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28185.042.09 |