Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE) (KITE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplantation; Medication Non-Adherence; Renal Transplant Recipients; Immunosuppressive Therapy
• Intervention / Treatment: Behavioral: Education and Telephone Counseling Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr.; Phone Number: +905548758383; Email: tugbaalbayram@gmail.com

Study Locations

• Turkey (Türkiye)
  • Şehitkamil
    • Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
      • Gaziantep University Sahinbey Research and Application Hospital
      • Contact: TUGBA ALBAYRAM; Phone Number: 05548758383; Email: tugbaalbayram@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education and Telephone Counseling Program; 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.	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.; Other Names: Immunosuppressive Adherence Education; Nurse-Led Tele-Counseling
No Intervention: Standart Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Score to Immunosuppressive Medication	Medication adherence will be assessed using the Immunosuppressive Medication Adherence Scale (11 items). Total scores range from 11 to 55, with higher scores indicating better medication adherence. Participants will complete the scale at baseline and at Week 8. An increase in score reflects improved adherence following the education and telephone counseling intervention.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability in Tacrolimus Trough Levels	Tacrolimus trough concentrations will be monitored during routine clinical visits. Variability will be calculated using the standard deviation (SD) of trough levels between baseline and Week 8. An SD greater than 2.48 is considered indicative of medication non-adherence according to predefined clinical criteria. Lower variability reflects better biological consistency of medication adherence.	Baseline and Week 8
Medication Knowledge Score	4 weeks and 8 weeks	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.

Collaborators and Investigators

• Sponsor: University of Gaziantep

Publications and helpful links

General Publications

• 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 Nonadherence in Adult Renal Transplant Patients: a literatüre review. Transplant International, 18, 1121-1133. 3. Dew, MA., Di Martini, AF., De Vito Dabbs, A., Myaskovsky, L. ve diğerleri. (2007). Rates and Risk Factors for Nonadherence to the Medical Regimen After Adult Solid Organ Transplantation. Transplantation, 83, 858-873. 4. Hansen, R., Seifeldin, R. ve Noe, L. (2007). Medication Adherence in Chronic Disease: Issues in Posttransplant Immunosuppression. Transplantation Proceedings, 39, 1287-1300. 5. Vlaminck, H., Maes, B., Evers, G., Verbeke, G. ve Lerut, E. (2004). Prospectives Study on Late Consequences of Subclinical Non-Compliance with Immunosuppressive Therapy in Renal Transplant Patients. American Journal of Transplantation, 4, 1509-1513. 6. Butler, J.A., Roderick, P., Mullee, M., Mason J.C. ve Peveler R.C. (2004). Frequency and Impact of Nonadherence to Immunosuppressants After Renal Transplantation: A Systematic Review. Transplantation, 77(5), 769-776. 7. Dobbels, F., De Geest, S. ve Van Cleemput, J. (2004). Effect of Late Medication Non-Compliance on Outcome After Heart Transplantation: a 5 Year Follow-Up. Journal of Heart and Lung Transplantation, 23, 1245. 8. Morrissey, P.E., Reinert, S., Yango, A., Gautam, A., Monaco A. ve Gohh R. (2005). Factors contributing to acute rejection in renal transplantation: the role of noncompliance. Transplant Proceedings, 37(5), 2044-2047. 9. Michelon, T.F., Piovesan, F., Pozza, R., Castilho, C., Bittar, A.E., Keitel, E. ve diğerleri. (2002). Noncompliance as a Cause of Renal Greft Loss. Transplantation Proceeding, 34(7), 2768-2770.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Patient Education; Kidney Transplant; Medication Adherence; Telephone Counseling; Immunosuppressive Medication; Tacrolimus Levels
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 2022/441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data (IPD) will not be shared because the dataset contains sensitive clinical information, including laboratory values and medication adherence details from kidney transplant recipients. Due to privacy concerns, ethical considerations, and institutional regulations regarding the protection of personal health data, de-identified datasets will not be made publicly available. Aggregated results will be reported in publications without revealing individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No