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临床试验/NCT06004102
NCT06004102已完成不适用

Impact of Text Message Reminders on Immunosuppressive Medication Adherence Among Kidney Transplant Recipients: A Randomized Controlled Study

Akdeniz University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
The effect of sending reminder text messages on immunosuppressive medication adherence

研究概览

简要总结

Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.

Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft rejection.

Design: A randomized controlled trial was conducted from January to October 2021 and conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.

Methods: This randomized controlled trial included a total of 100 patients receiving a kidney transplant, 50 in the intervention group and 50 in the control group. Patients in the intervention group were sent text message reminders four times a day during the 6th to 9th months after transplantation. Control patients received no such intervention. Tacrolimus concentrations in the bloodstream were monitored for all participants through measurements taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive Characteristics Form and Immunosuppressive Medication Adherence Scale.

Research hypotheses H1- Sending text message reminders improves immunosuppressive medication adherence in kidney transplant recipients.

H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood profiles in kidney transplant recipients.

H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence Scale and mean tacrolimus plasma levels in kidney transplant recipients.

H4- There is a correlation between the sociodemographic and descriptive characteristics of kidney transplant recipients and their mean scores from the Immunosuppressive Medication Adherence Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 18 years or older
  • Being a recipient of a kidney transplant for the first time
  • Being a kidney transplant recipient at post-transplant month 6 with scheduled follow-up until month 9
  • Ongoing immunosuppressive drug therapy
  • Absence of any disability that hinders communication
  • No diagnosis of psychological and mental problems
  • Being an active cell phone user
  • Ability to read and write
  • Voluntary participation in the research.

排除标准

  • Hospitalization for any reason during the research period
  • History of combined or dual organ transplantation.

结局指标

主要结局

The effect of sending reminder text messages on immunosuppressive medication adherence

时间窗: baseline and 9 months

The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.

次要结局

未报告次要终点

研究者

发起方
Akdeniz University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Erdal

Nurse

Akdeniz University Hospital

研究点 (2)

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