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Validation of the French Version of the Lithium Knowledge Test (LKT)

Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06033326
Acronym
LKT
Enrollment
22
Registered
2023-09-13
Start date
2023-11-28
Completion date
2025-11-28
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward

Keywords

Lithium, observance, security, Lithium Knowledge Test

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the factorial validity of the score from the first completed LKT self-questionnaire2 yaersBaseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years

Secondary

MeasureTime frameDescription
Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.72 yaersBaseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
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 D0.2 yaersBaseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.2 yearsBaseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
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 treatment2 yearsBaseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
Search for factors associated with the LKT self-questionnaire score at J0.2 yearsBaseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026