Primary objective of the study is to measure patiënt experience of POC testing. Secondary objectives are correlation of POC testingof antipsychotic blood values with those of the Standard (venous) method and to perform a cost-effectiveness analysis…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
patients complete questionnaires on their experience using a VAS scale., risks
are negligible (only one extra capillary prick besides
regularly performed venous blood sample drawing) and therefore the burden is
minimal and the study is group related (study can
only be done using these patients groups).
Secondary outcome
Correlation between serum values of clozapine and cost-effectiveness of point
of care testing for clozapine.
Background summary
Patients who suffer from schizophrenia experience symptoms such as disorganized
thinking, hallucinations and delusions, regularly
complicated by abuse of drugs, suicidality and abnormal behavior, including
aggressive behaviour. The disease is treated by
antipsychotic drugs. Clozapine is an atypical antipsychotic drug for
treatment-resistant schizophrenia. Clozapine is known as a last
resort treatment option. For its effectivity clozapine has an unique
opportunity among antipsychotic drugs. Clozapine may cause
potentially dangerous side-effects for which intensive monitoring is mandatory,
including blood-sample testing. Schizophrenia
patients often experience blood-sample drawings as a part of their package of
symptoms, such as fear or psychotic experiences.
This makes drawing blood samples a challenge. Feasible, simplified, fast and
easy clozapine blood level tests are desirable. This
study is the first point of care (POC) clozapine-level test developed for daily
practice in the Netherlands. No study has yet described
patiënt experience and costs in an expert clinic in minimal invasive POC
antipsychotic drug blood level testing in therapy resistant
schizophrenia in Europe.
Study objective
Primary objective of the study is to measure patiënt experience of POC testing.
Secondary objectives are correlation of POC testing
of antipsychotic blood values with those of the Standard (venous) method and to
perform a cost-effectiveness analysis.
Study design
This is an cross-sectional explorative pilot study including 30 patients.
Study burden and risks
patients complete questionnaires on their experience using a VAS scale. Risks
are negligible (only one extra capillary prick besides
regularly performed venous blood sample drawing) and therefore the burden is
minimal and the study is group related (study can
only be done using these patients groups).
Sandifoortdreef 19
Leiden 2333ZZ
NL
Sandifoortdreef 19
Leiden 2333ZZ
NL
Listed location countries
Age
Inclusion criteria
patients aged 18 years of age or older, receiving clozapine for schizophrenia
or schizo-affective disorder, accessible for treatment and follow-up and able
(investigated by the treating physician) or willing to participate/giving
informed consent for participation in this study.
Exclusion criteria
Patients acutely involuntary admitted to the hospital (In Dutch:
Crisismaatregel, former IBS), patients and/or not able or willing to give
their informed consent (In Dutch: wilsonbekwaam inzake afweging participatie in
dit onderzoek)
Design
Recruitment
metc-ldd@lumc.nl
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 | NL74320.058.20 |