Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

University of Gaziantep

Status: Not yet enrolling

Conditions: Kidney Transplantation; Immunosuppressive Therapy; Renal Transplant Recipients; Medication Non-Adherence

Treatments: Behavioral: Education and Telephone Counseling Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07364123

2022/441

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Education and Telephone Counseling Program

Experimental group

Description:

A nurse-led structured education session covering immunosuppressive medication use, side effects, timing, and self-management strategies. Participants receive an educational booklet and are provided with scheduled telephone counseling sessions designed to reinforce adherence, address patient questions, and support problem-solving. All calls and follow-up interactions are documented. Pre-test, post-test, and follow-up adherence assessments are administered.

Treatment:

Behavioral: Education and Telephone Counseling Program

Standart Care

No Intervention group

Description:

Participants receive standard post-transplant clinical follow-up provided by the hospital, without additional structured education or telephone counseling. Routine care includes medical assessments and medication management per standard transplant center procedures.