Clinical trial NCT06033326: Validation of the French Version of the Lithium Knowledge Test (LKT)
Official title: Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward
Keywords: Lithium
observance
security
Lithium Knowledge Test
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in an adult psychiatric ward or staying in an EPSM in the cities included in this study

Brief summary: Lithium is a drug used to treat several psychiatric illnesses. This medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose.

The blood dosage of the drug and the patient's knowledge of the drug are necessary to optimize and secure the drug intake.

The objective of this observational study is to confirm that the score obtained by the LKT lithium knowledge self-questionnaire translated into French is representative of the knowledge of patients treated with lithium.

Participants will be asked to complete this questionnaire twice, and the scores obtained will be compared to the blood lithium level to see if a good score is associated with an effective blood lithium concentration.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in a psychiatric ward or in an EPSM for more than 10 consecutive days
* Patient treated with IR or ER lithium LI
* Patient over 18 years of
* Patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for lithiaemia testing
* Obtain patient's non-opposition

Exclusion Criteria:

* Clinically unstable patient or patient with a cognitive disorder that makes it impossible to perform interview and/or completion of the LKT self-questionnaire
* Patients under guardianship or trusteeship
* Illiterate patients
* Patient with a therapeutic target concentration different from general recommendations (e.g. elderly subject)
* Patient receiving a pharmaceutical interview or any other interview between the completion of the 1 and 2nd questionnaires, likely to modify the LKT score.

Primary outcomes:
measure: Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
timeFrame: 2 yaers
Secondary outcomes:
measure: Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7
timeFrame: 2 yaers
measure: External validity of the LKT self-questionnaire by measuring the correlation between the lithiaemia assay at D0 and the score obtained on the self-questionnaire at D0.
timeFrame: 2 yaers
measure: Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.
timeFrame: 2 years
measure: Comparison of lithiaemia at D0 between patients with good knowledge (i.e. a LKT self-questionnaire score at D0 > 6) and those with poor knowledge of treatment
timeFrame: 2 years
measure: Search for factors associated with the LKT self-questionnaire score at J0.
timeFrame: 2 years
Other outcomes:
Locations:
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