Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

Официальное название

Education and Telephone Counseling to Improve Adherence to Immunosuppressive Medication in Kidney Transplant Recipients: A Randomized Controlled Trial

Обзор

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.

Подробное описание

Kidney transplant recipients are required to follow lifelong immunosuppressive therapy to prevent rejection and preserve graft function. However, studies consistently demonstrate substantial rates of non-adherence, which is associated with increased acute rejection, graft dysfunction, hospitalization, and higher long-term mortality. Behavioral, educational, and psychosocial factors play critical roles in medication adherence, particularly during the early post-transplant period when patients must adapt to complex medication regimens and lifestyle changes.

This randomized controlled trial was designed to evaluate whether a structured nurse-led education program combined with scheduled telephone counseling can improve adherence to immunosuppressive medication among kidney transplant recipients. The intervention includes individualized education, distribution of an adherence-focused patient booklet, reinforcement of medication-taking routines, problem-solving support, and ongoing telephone follow-up to address questions and encourage self-management behaviors.

Participants are randomly assigned to an intervention group or a usual-care control group. Adherence is assessed using a validated self-report scale and by monitoring variability in tacrolimus levels, which is commonly used as an objective indicator of medication-taking consistency. The assessment schedule includes baseline and follow-up evaluations over 8 weeks. The study also incorporates pre-test and post-test evaluations to measure changes in participants' medication knowledge following the educational intervention.

The results of this study are expected to provide evidence on whether integrating telehealth-based nursing support into routine post-transplant care improves medication adherence and supports better clinical outcomes. The intervention model developed here may offer a practical, patient-centered strategy that can be adopted in transplant centers with limited resources.

Вмешательства

• Поведенческое 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 pati

Первичные конечные точки

• Adherence Score to Immunosuppressive Medication [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (2)

• Variability in Tacrolimus Trough Levels [Срок оценки: Baseline and Week 8]
• Medication Knowledge Score [Срок оценки: Medication knowledge will be assessed using a 22-item questionnaire on dosage, timing, side effects, interactions, and rejection signs. Scores range 0-22; higher scores indicate better knowledge. Assessed at baseline, Week 4, and Week 8.]

Критерии участия

Критерии включения

• Adult kidney transplant recipients aged 18 years or older
• At least 1 month post-kidney transplantation
• Able to provide informed consent
• Cognitively intact and oriented to person, place, and time
• Able to communicate via telephone
• Voluntarily willing to participate in the study

Критерии исключения

• Under 18 years of age
• Severe cognitive impairment preventing participation
• Inability to communicate effectively (hearing or speech limitations without support)
• Patients who do not meet the post-transplant time threshold (less than 1 month)
• Patients unwilling or unable to participate in follow-up sessions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Gaziantep University Sahinbey Research and Application Hospital — Gaziantep

Публикации

• 1. De Bleser, L., Dobbels, F., Berben, L., Vanhaecke, J., Verleden, G. ve diğerleri. (2011). The Spectrum of Nonadherence with Medication in Heart, Liver, and Lung Transplant Patients Assessed in Various Ways. Transplant International, 24, 882-891. 2. Denhaerynck, K., Dobbels, F., Cleemput, I., Desmyttere, A., Keller, PS. ve diğerleri. (2005). Prevalence, Consequences and Determinants of Nonadhere

Идентификаторы

NCT: NCT07364123 · 2022/441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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