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临床试验/NCT02606175
NCT02606175已完成不适用

Medication Knowledge, Medication Adherence and Health Literacy in Patients Who Underwent a Kidney Transplantation.

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test

研究概览

简要总结

Patients who receive a kidney transplant have to learn in 10-14 days which anti-rejection medication to take, how to take it ,... This learning process is attended by the nurses of the ward. This study wants to measure the degree of medication knowledge, health literacy and medication adherence of those patients.

详细描述

Patients who receive a kidney transplant arrive at the abdominal transplantation surgery ward after surgery. Within 10-14 days they learn which anti-rejection medication they have to take, how they have to take it and to what they have to pay attention. This learning process is attended by the nurses of the ward.

It is already known that a bad medication adherence is related to a higher rejection rate and mortality of patients who receive a kidney transplant. Bad medication knowledge and low health literacy are correlated with a bad medication adherence. Data about the level of health literacy of the Belgian population (and certainly of patients who just received a kidney transplant) are scarce.

The main purpose of this study is to have an idea of the extent of medication knowledge, heath literacy and adherence in patients who received a renal transplant.

Therefore, a prospective cohort study will be performed. Adult patients admitted for a renal transplantation, will be included after obtainment of informed consent. The patients will be followed for 2 years. On predefined time points, the participants will have to fill in questionnaires and tests: on discharge 2 tests that measure health literacy, the "Basel Assessment of Adherence to Immunosuppressive Medications Scale" (BAASIS), the medication knowledge test and a questionnaire about demographic factors. At 1 month post-transplantation the BAASIS test and medication knowledge test, 3 months post-transplantation the 2 tests assessing health literacy, the BAASIS test and medication knowledge test and finally after 1 and 2 years all the tests (4 in total) and questionnaire assessing demographic factors

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who are admitted at the abdominal transplantation surgery ward and just underwent a kidney transplantation

排除标准

  • Patients who cannot sufficiently write, read or speak Dutch.
  • Patients who don't take care of their medication themselves.

结局指标

主要结局

Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test

时间窗: Up to 36 months

Measurement: quantitative score

Degree of medication adherence pre- and post kidney transplantation assessed by the BAASIS test

时间窗: Up to 36 months

Measurement: BAASIS = 4 questions assessing adherence. If the patient answers 'no' on at least 1 question, the patient is categorized as 'non-adherent'.

Degree of health literacy pre- and post kidney transplantation as measured by the NVS-D and FCCHL test

时间窗: Up to 36 months

Measurement: NVS-D = quantitative score (max = 6 points) with 3 groups: low health literacy = 0-1; intermediate health literacy = 2-3; high health literacy = 4-6. The FCCHL contains 3 subitems (functional, communicative and critical health literacy) Each subitem contains 4 questions. Each question is rated on a 4-point scale, ranging from 1 to 4 (4 indicating high health literacy). The scores for the items in a scale are summed and divided by the number of items in the scale to give a scale score (theoretical range 1-4).

次要结局

  • Correlation between degree of medication knowledge, degree of health literacy and/or degree of medication adherence(Up to 36 months)
  • Defining risk factors (assessed by the demographic questionnaire) related to the degree of medication knowledge, health literacy and/or medication adherence(Up to 36 months)
  • Type of evolution in the degree of medication knowledge (assessed by self-edited test, see above), health literacy (assessed by NVS-D and FCCHL, see above) and/or medication adherence (assessed by BAASIS, see above).(Up to 36 months)
  • Correlation between the evolution of medication knowledge, health literacy and/or medication adherence, and the outcome parameters (trend of serum creatinine, result of biopsy of kidney transplant, trend and variation of tacrolimus' trough level).(Up to 36 months)
  • Correlation between the degree of medication knowledge, health literacy and/or medication adherence, and outcome parameters (trend of serum creatinine, result of biopsy of kidney transplant, trend and variation of tacrolimus' trough level)(Up to 36 months)
  • Correlation between evolution of medication knowledge, evolution of health literacy and/or evolution of medication adherence(Up to 36 months)
  • Defining risk factors (assessed by the demographic questionnaire) related to the evolution of medication knowledge, health literacy and/or medication adherence(Up to 36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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