NCT07364123

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 5, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 15, 2026

Last Update Submit

January 26, 2026

Conditions

Kidney TransplantationMedication Non-AdherenceImmunosuppressive TherapyRenal Transplant Recipients

Keywords

Kidney TransplantImmunosuppressive MedicationMedication AdherenceTelephone CounselingPatient EducationTacrolimus Levels

Outcome Measures

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.

    Baseline and Week 8

Secondary Outcomes (2)

  • Variability in Tacrolimus Trough Levels

    Baseline and Week 8

  • 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.

Study Arms (2)

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.

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.

Interventions

Education and Telephone Counseling ProgramBEHAVIORAL

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.

Also known as: Immunosuppressive Adherence Education, Nurse-Led Tele-Counseling
Education and Telephone Counseling Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University Sahinbey Research and Application Hospital

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr.

CONTACT

+905548758383tugbaalbayram@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dr

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)