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临床试验/NCT04715412
NCT04715412已完成不适用

Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月10日最近更新:
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
1
主要终点
Specified clinical and educational outcome

研究概览

简要总结

As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training & data collection.

排除标准

  • Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer patients.

结局指标

主要结局

Specified clinical and educational outcome

时间窗: 6 months

Self-reported taking adherence \[TA, percentage of doses taken in comparison to the total number of doses prescribed\]. Patients will be classified as being adherent for those with TA ≥80 or non-adherent for those with TA \<80

次要结局

  • CBC(6 months)
  • Renal function(6 months)
  • Serum trough Immunosuppressant level (C0)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Mohamed Salah ElDin Diab ELBohy

Assistant professor of Clinical Phramcy

Future University in Egypt

研究点 (1)

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