In the ASAP study, we aim to investigate pain associated with capillary sampling in a population of patients with serious psychiatric problems, compared to pain associated with standard venous access. This study is a pilot for a planned larger study…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is pain measured by the VAS scale.
Secondary outcome
The percentage of participants able to perform the procedure themselves. Scores
about the acceptability given by the participants. The sampling and work flow
of the finger pick.
Background summary
Antipsychotics are the mainstay of treatment for schizophrenia and are an
important adjunctive treatment for bipolar disorders. However, using
antipsychotics contributes to higher mortality risk in the population and some
antipsychotics need therapeutic drug monitoring. Therefore monitoring blood
parameters is indicated. The metabolic parameters and blood levels of clozapine
needs to be tested frequently. In clinical practice it has proven to be
challenging. One burden in monitoring is performing a phlebotomy. Another
option could be performing a capillary sampling.
Study objective
In the ASAP study, we aim to investigate pain associated with capillary
sampling in a population of patients with serious psychiatric problems,
compared to pain associated with standard venous access. This study is a pilot
for a planned larger study.
Study design
An open, single group, non-blinded within subject design.
Study burden and risks
The participants will be asked to perform one extra capillary blood and fill in
the questionnaires. This consist of one visit. Performing a capillary blood
collection comes with a possibility of a short time skin irritation. Further,
there are no risks associated with the participation. no influence on therapy
The participants are selected of a population of patient
Dr. Molewaterplein 40
Rotterdam 3015GB
NL
Dr. Molewaterplein 40
Rotterdam 3015GB
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Written informed consent has been obtained from the patient
- Using an antipsychotic
- Scheduled for metabolic screening according to standard clinical care
Exclusion criteria
- Unable to draw samples for study purposes
- Language barriers
- Unable to give informed consent to all aspects of the study
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 |
|---|---|
| CCMO | NL82911.078.22 |