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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Education and Telephone Counseling Program
BehavioralA 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Medication Knowledge Score
4 weeks and 8 weeks
Sponsors and contacts
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