No registrations found.
ID
Source
Brief title
Health condition
correlation
lithium
bipolar disorder
self test
correlatie
lithium
bipolaire stoornis
zelftest
Sponsors and support
Medisch Spectrum Twente, Enschede, The Netherlands
GO and EFRO funding the NIRION project
Intervention
Outcome measures
Primary outcome
From the measurements the correlation between the measurement systems, the accuracy and liability are calculated and analyzed using Bland & Altman statistics and CLSI EP-9 Method Comparison. Precision analysis is done by standard deviation on residual, equivalence is shown by Anova analysis.
Secondary outcome
Information on user friendlyness of the Medimate Minilab system.
Background summary
N/A
Study objective
Show accurate and proper functioning of the Medimate MiniLab system for professional and self test use.The objective of the studies is to show the performance of 10% or 0.1 mmmol/l @ 95% confidence interval.
Study design
N/A
Intervention
Correlation study between standard validated laboratory equipment for lithium and the Medimate MiniLab. The lithium results of whole blood finger prick sample measured on the Medimate device are to be compared to the results of venous blood sample on the laboratory equipment. Both samples will be taken at the same instant.
The research will consists of three different phases, to be carried out after each other.
Phase 1: Show correlation between golden standard and Medimate system within artificial laboratorial setting based on precision and proven equivalence.
Phase 2: Validation of the system within daily clinical setting by laboratory professionals by method comparison based on accuracy.
Phase 3: Validation of the system in use by lay persons; physicians and patients.
De Veldmaat 10
Marian Tellegen
Enschede 7522 NM
The Netherlands
marian.tellegen@medimate.com
De Veldmaat 10
Marian Tellegen
Enschede 7522 NM
The Netherlands
marian.tellegen@medimate.com
Inclusion criteria
Bipolar patients > 18 years, using lithium and treated and selected by psychiatrists (clinic or outpatient) of MST Enschede or other medical centers.
Exclusion criteria
1. Non-lithium users;
2. Not able to read or write dutch.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL2846 |
| NTR-old | NTR2988 |
| CCMO | NL34961.044.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |