Effect of Digital Follow-up Supported Patient Education on Immunosuppressive Medication Adherence and Quality of Life in Liver Transplant Recipients: A Single-Blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Immunosuppressive Medication Adherence
研究概览
简要总结
This randomized controlled study aimed to evaluate the effect of digital follow-up supported patient education on immunosuppressive medication adherence and quality of life in adult liver transplant recipients. Participants in both groups received standard discharge education. The intervention group additionally received structured digital follow-up messages for 12 weeks, while the control group received standard care only. Medication adherence and quality of life were assessed before and after the intervention using validated questionnaires.
详细描述
Lifelong adherence to immunosuppressive medication is essential for preventing graft rejection and maintaining long-term graft survival after liver transplantation. However, medication non-adherence remains a common problem and may negatively affect patient outcomes and quality of life. Digital follow-up interventions may improve adherence by providing regular reminders and educational support after discharge.
This single-blind randomized controlled trial was conducted at the Liver Transplant Center of Acibadem Kent Hospital, İzmir, Türkiye. Adult liver transplant recipients who met the eligibility criteria were randomly assigned to either a digital education group or a control group. All participants received standard discharge education. In addition, participants in the intervention group received structured digital follow-up messages for 12 weeks. The control group received routine follow-up care only.
The primary outcome was immunosuppressive medication adherence, assessed using the Immunosuppressive Medication Adherence Scale (MMAS-8). The secondary outcome was quality of life, assessed using the Chronic Liver Disease Questionnaire (CLDQ 2.0). Outcomes were evaluated before the intervention and at the end of the 12-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was conducted as a single-blind randomized controlled trial. The statistician/outcome assessor was blinded to group allocation during data analysis. Participants and the investigator providing the intervention were not blinded.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Having undergone liver transplantation.
- •Currently receiving immunosuppressive therapy after liver transplantation.
- •Ability to read and write in Turkish.
- •Ability to use a smartphone to receive and follow digital messages.
- •Willingness to participate voluntarily in the study.
- •Provision of written informed consent.
排除标准
- •Experiencing an acute rejection episode during the study period.
- •Presence of cognitive, psychiatric, or communication problems that would interfere with participation in the study.
- •Inability to regularly follow digital messages.
- •Difficulty reading and understanding Turkish.
- •Inability to maintain communication throughout the study period.
- •Refusal to participate in the study.
结局指标
主要结局
Immunosuppressive Medication Adherence
时间窗: Baseline and 12 weeks
Immunosuppressive medication adherence was assessed using the Immunosuppressive Medication Adherence Scale used in this study.
次要结局
- Chronic Liver Disease Quality of Life Score (CLDQ 2.0)(Baseline and 12 weeks)
研究者
Cansu Yıldız
Principal Investigator
Izmir Tinaztepe University