Kidney TransplantationKITENCT07364123
Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)
A study testing Education and Telephone Counseling Program in people with Kidney Transplantation and Medication Non-Adherence, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation, Medication Non-Adherence, Immunosuppressive Therapy
- What is being tested?
- Education and Telephone Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr. contact
Turkey (Türkiye)1 site
Gaziantep University Sahinbey Research and Application Hospital
Gaziantep, Şehitkamil, 27310
TUGBA ALBAYRAM, 05548758383, tugbaalbayram@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation, Medication Non-Adherence, Immunosuppressive Therapy, Renal Transplant Recipients
- Being tested
- Education and Telephone Counseling Program
- Keywords
- Kidney Transplant, Immunosuppressive Medication, Medication Adherence, Telephone Counseling, Patient Education, Tacrolimus Levels
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Telephone Counseling ProgramBehavioural
Also called Immunosuppressive Adherence Education, Nurse-Led Tele-Counseling
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.
| Study group | Role | What they receive |
|---|---|---|
| Education and Telephone Counseling Program | Experimental | 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. Receives: Behavioral: Education and Telephone Counseling Program |
| Standart Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (2)
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.
Measured: Baseline and Week 8
Medication Knowledge Score
4 weeks and 8 weeks
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Albayram, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364123
- Sponsor's protocol ID
- 2022/441
- Acronym
- KITE
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education and Telephone Counseling to Improve Adherence to Immunosuppressive Medication in Kidney Transplant Recipients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07364123
- Acronym / sponsor ID
- KITE / 2022/441
- Conditions
- Kidney Transplantation, Medication Non-Adherence, Immunosuppressive Therapy, Renal Transplant Recipients
- Keywords
- Kidney Transplant, Immunosuppressive Medication, Medication Adherence, Telephone Counseling, Patient Education, Tacrolimus Levels
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Education and Telephone Counseling Program | Experimental | Behavioral: Education and Telephone Counseling ProgramA 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. |
| Standart Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Telephone Counseling ProgramAlso: Immunosuppressive Adherence Education, Nurse-Led Tele-CounselingA 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. | Behavioural | Education and Telephone Counseling Program |
Primary outcome
Adherence Score to Immunosuppressive Medication
Time frame: 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.
2 secondary outcomes
Variability in Tacrolimus Trough Levels
Time frame: Baseline and Week 8
Medication Knowledge Score
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background1. 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Telephone Counseling Program in people with Kidney Transplantation and Medication Non-Adherence, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr. (+905548758383, tugbaalbayram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Score to Immunosuppressive Medication (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.