Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
时间窗: 2 yaers
Baseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
次要结局
- 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(2 years)
- Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.(2 years)
- Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7(2 yaers)
- 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 yaers)
- Search for factors associated with the LKT self-questionnaire score at J0.(2 years)