Education and Telephone Counseling to Improve Adherence to Immunosuppressive Medication in Kidney Transplant Recipients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence Score to Immunosuppressive Medication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Education and Telephone Counseling Program
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.
干预措施: Education and Telephone Counseling Program (Behavioral)
Standart Care
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.
结局指标
主要结局
Adherence Score to Immunosuppressive Medication
时间窗: 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.
次要结局
- 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.)
研究者
Tuğba Albayram
Research Assistant Dr
University of Gaziantep