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临床试验/NCT05821946
NCT05821946已完成不适用

The Effect of Web-Based Multi-source Training on the Prevention of Urinary Tract Infections in Adult Kidney Transplant Recipients on Clinical Outcomes

Akdeniz University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Infection status

研究概览

简要总结

Purpose: The study aims to examine the effect of web-based multi-source training on the prevention of urinary tract infections in adult kidney transplant recipients on clinical outcomes.

Design: The study is a single-center, parallel-group, single-blind, pretest, and posttest randomized controlled experimental study.

Methods: A total of 90 kidney transplant recipients, 45 in the control group and 45 in the intervention group will be included in the study. Kidney transplant recipients will be randomized on the day of discharge. Before discharge, the Patient Socio-Demographical/Descriptive Characteristics Form and the Discharge Readiness Scale will be applied to the control and intervention groups. Routine training and aimed at preventing urinary tract infections web-based multi-source training will be provided to the intervention group. The developed educational material was evaluated by experts in terms of literacy, reliability, and information quality. As multiple resources on the web: there will be written and visual texts of the educational material, as well as podcasts and animation videos. Web page usability will be evaluated with the System Usability Scale. Individuals will be able to benefit from each of these multiple educational resources according to their preferences. The control group will be directed to the organ transplantation handbook on the website of the routine education and organ transplant center. After discharge, the follow-ups of the intervention and control group were carried out during the first 6-month post-transplant standard follow-up process of the center (2. day; once a week for the first month; every ten days for up to 1-3 months; every three weeks for the next 3-6 months) will be performed. When patients come to their controls, the results of routine examinations (complete urinalysis, urine culture taken when necessary, hospitalization, emergency application, and other data) will be taken from the Hospital Information Management System. In addition, the recipients' opinions in the intervention group on the Web-Based Multi-Resource Training Program will also be received at the end of the 6th month. The research adhered to the Standard Protocol Items: Recommendations for Interventional Trials-SPIRIT (2013) and Consolidated Standards of Reporting Trials-CONSORT (2018) checklists.

详细描述

  1. INTRODUCTION

Kidney transplant (KTx) is the most common and successful treatment of all types of organ replacement. However, urinary tract infections (UTIs), commonly seen in kidney transplant recipients, negatively affect successfully performed kidney transplantation. Therefore, prevention and effective infection treatment are of great importance to optimize, maintain, and prolong the function of the graft and avoid rejection in KTx recipients. Although UTIs can occur at any time after transplantation, they are more common in the early stages of KTx. Urinary tract infections cause frequent hospital admissions and repeated hospitalizations. This situation causes frequent hospital admissions and repeated hospitalizations of patients. Post-kidney transplant UTIs with high recurrence rates burden health economics and treatment outcomes.

Websites compatible with mobile devices, one of the methods of meeting health needs, significantly affect people's ability to manage their health and acquire long-term healthy lifestyle behaviors. It also can reduce health expenditures. However, in the literature review, there were no studies examining the effect of education and training to prevent urinary tract infections in adult KTx recipients on clinical outcomes. The aim of this study was to evaluate the effect of web-based multi-source training on clinical outcomes in adult kidney transplant recipients to prevent urinary tract infections.

The following hypotheses will be tested.

H1-1: The effect of web-based multi-source education to prevent UTIs in adult kidney transplant recipients on infection is significantly different than in the control group.

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
Double (Participant, Outcomes Assessor)

盲法说明

In the research, the participants will be blinded; the researcher cannot be blinded because he is practicing. To avoid statistical evaluator bias, statistical evaluations will be made on a data file where the intervention or control group is not explicitly stated by the researcher.

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
是

入选标准

  • •18-65 years
  • •Ability to speak, read and write Turkish.
  • •Becoming a kidney transplant recipient for the first time
  • •Having and using a smartphone (IOS or Android) or computer or tablet
  • •Having internet access

排除标准

  • •Willingness to leave the research at any time
  • •Re-operation in the follow-up process
  • •Hospitalization due to non-transplant problems during follow-up
  • •Not using the web-based application despite three reminder messages a week.

研究组 & 干预措施

Web-Based Multi-Source Training on the Prevention of Urinary Tract İnfections

Experimental

In addition to routine training, web-based multi-source training will be provided on the prevention of urinary tract infections in adult kidney transplant recipients.

干预措施: Web-Based Multi-Source Training on the Prevention of Urinary Tract İnfections (Other)

Control group

No Intervention

Routine training and before discharge will be directed to the organ transplant handbook on the transplant center's website.

结局指标

主要结局

Infection status

时间窗: Up to 6 months after discharge

The urinary tract infection status of kidney transplant recipients will be evaluated by obtaining the results of routine examinations performed at standard controls after discharge from the Hospital Information Management System.

Number of applications to the emergency department

时间窗: Up to 6 months after discharge

The number of applications to the emergency department due to urinary tract infections of kidney transplant recipients will be obtained from the Hospital Information Management System.

Hospital readmission status

时间窗: Up to 6 months after discharge

Re-hospitalization status of kidney transplant recipients due to urinary tract infection will be obtained from the Hospital Information Management System.

次要结局

  • Views of adult kidney transplant recipients on web-based multi-source urinary tract infection prevention education(End of 6 months after discharge)
  • Adult kidney transplant recipients who are ready for discharge versus those who are not ready for release are significantly different in clinical outcomes.(Within 24 hours before discharge)

研究者

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

Fatma CEBECİ

Professor Doctor

Akdeniz University

研究点 (1)

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