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Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

NCT07364123 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-28

No results posted yet for this study

Summary

This randomized controlled interventional study aims to evaluate the effect of structured education and telephone counseling on immunosuppressive medication adherence among kidney transplant recipients. Poor adherence to immunosuppressive therapy after kidney transplantation is a major risk factor for acute rejection, graft loss, and increased morbidity. Education and behavioral support interventions delivered by nurses may improve medication understanding, adherence behaviors, and self-management skills.

In this trial, 60 participants will be randomly assigned to either an intervention group receiving individualized education, an immunosuppressive medication adherence booklet, and scheduled telephone counseling sessions, or a control group receiving routine clinical care. Adherence will be assessed using the Immunosuppressive Medication Adherence Scale and biological monitoring through tacrolimus level variability over 8 weeks. Additional outcomes include changes in medication knowledge scores based on pre-test and post-test assessments.

The study will contribute evidence regarding whether nurse-led telephone counseling and structured education can enhance adherence, improve clinical follow-up, and support long-term graft success in kidney transplant patients.

Conditions

  • Kidney Transplantation
  • Medication Non-Adherence
  • Immunosuppressive Therapy
  • Renal Transplant Recipients

Interventions

BEHAVIORAL

Education and Telephone Counseling Program

A nurse-led structured behavioral intervention designed to improve adherence to immunosuppressive medication. The intervention includes an individualized education session at discharge, provision of an educational booklet, and scheduled telephone counseling at 7-15 days, 4 weeks, and 8 weeks. Participants also receive access to a dedicated phone line for additional support. Counseling focuses on medication routines, problem-solving strategies, reinforcing adherence behaviors, and addressing patient concerns. Pre-test and post-test assessments are used to evaluate changes in knowledge and adherence.

Sponsors & Collaborators

  • University of Gaziantep

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-05-15
Completion
2026-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364123 on ClinicalTrials.gov