Immunosuppressive Therapy, Kidney Transplantation, Medication Non-Adherence, Renal Transplant Recipients
Conditions
Keywords
Kidney Transplant, Immunosuppressive Medication, Medication Adherence, Telephone Counseling, Patient Education, Tacrolimus Levels
Brief summary
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.
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.
Interventions
BEHAVIORALEducation 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.
Sponsors
University of Gaziantep
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomly assigned to either an education plus telephone counseling group or a standard care control group, and both groups will be followed over 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Score to Immunosuppressive Medication | Baseline and Week 8 | 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
| Measure | Time frame | Description |
|---|---|---|
| Variability in Tacrolimus Trough Levels | Baseline and Week 8 | 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 | 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. | 4 weeks and 8 weeks |
Countries
Turkey (Türkiye)
Contacts
CONTACTTugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr.
Outcome results
None listed