NCT05821946

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 30, 2024

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

February 12, 2023

Last Update Submit

July 29, 2024

Conditions

Keywords

KidneyTransplantationAdultUrinary Tract InfectionPreventionNursingWeb-Based Multi-Source Education for PatientsMedical Informatics

Outcome Measures

Primary Outcomes (3)

  • Infection status

    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.

    Up to 6 months after discharge

  • Number of applications to the emergency department

    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.

    Up to 6 months after discharge

  • Hospital readmission status

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

    Up to 6 months after discharge

Secondary Outcomes (2)

  • 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

  • Views of adult kidney transplant recipients on web-based multi-source urinary tract infection prevention education

    End of 6 months after discharge

Study Arms (2)

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.

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

Control group

NO INTERVENTION

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

Interventions

Before discharge, individuals will be given a user name and password to enter the website by the researcher. The first access to the website will be made via the researcher's computer, and the website will be introduced. Individuals will be shown how to access the compatible website on Android and IOS phones and tablets by the researcher. Web-based multi-source training for individuals to prevent urinary tract infections will begin. The researcher will check the use of educational materials by individuals from the administrator's menu. To increase the effectiveness of the training, reminder, motivating, and supportive messages will be sent to the patients twice a week.

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fatma CEBECİ

    Akdeniz University

    PRINCIPAL INVESTIGATOR
  • Nihal KİRAZ

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is a single-center, parallel-group, single-blind, pretest, and posttest randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

February 12, 2023

First Posted

April 20, 2023

Study Start

April 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 30, 2024

Record last verified: 2023-10

Locations