Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

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.

Inclusion criteria

• 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

Exclusion criteria

• 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