Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Gaziantep

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Education and Telephone Counseling Program

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Education and Telephone Counseling ProgramExperimental treatment 1 intervention
Group B: Standart CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Week 8

Secondary outcomes

1

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.

Time frame
Baseline and Week 8
2

Medication Knowledge Score

4 weeks and 8 weeks

Time frame
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.

Other outcomes

Sponsors and contacts

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