Evaluation of the Impact of a Mobile Application Developed for Hemodialysis Patients on Treatment Adherence, Symptom Management and Clinical Parameters.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Treatment Adherence Score
研究概览
简要总结
This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, and motivational content. It also features reminder notifications, an "Ask the Expert" module, and personal symptom tracking.
The research will be conducted as a single-center, single-blind, randomized controlled experimental study. Participants will be assigned to intervention and control groups using block randomization. The intervention group will receive the mobile application, while the control group will receive standard care. Assessments will be carried out at baseline (T0), 1st month (T1), and 2nd month (T2).
The measurement tools to be used include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, clinical parameters such as serum potassium, phosphorus, and albumin will be evaluated.
A total of 72 patients (36 intervention, 36 control) will be included in the study. This study aims to assess the impact of a mobile health application on treatment adherence, symptom management, and clinical parameters among hemodialysis patients, and to develop a digital health model that can be integrated into nursing care.
详细描述
Chronic kidney disease is a major global public health problem, and most patients with end-stage renal disease (ESRD) depend on hemodialysis to survive. Patients undergoing hemodialysis often experience difficulties with treatment adherence, challenges related to dietary and fluid restrictions, as well as common symptoms such as fatigue, pain, and itching. These problems negatively affect their quality of life. Previous studies have reported that more than half of hemodialysis patients demonstrate poor treatment adherence, which is associated with increased mortality. Therefore, innovative and technology-based approaches are needed to improve adherence and reduce symptom burden.
In recent years, mobile health (mHealth) applications have been increasingly used in the management of chronic diseases. Such applications enable patients to monitor their health more closely, improve medication and dietary adherence, and receive support for symptom management. However, most existing studies in the literature have focused on only one dimension of adherence (such as medication or diet) and have not comprehensively evaluated symptom management together with biochemical parameters.
This study aims to investigate the effect of a newly developed mobile health application, created by the research team, on treatment adherence, symptom management (fatigue, pain, itching), and clinical parameters (serum potassium, phosphorus, albumin) among hemodialysis patients. The study will be conducted as a single-center, single-blind, randomized controlled trial including a total of 72 patients (36 intervention, 36 control). Participants will be assigned to groups using block randomization. The intervention group will receive the mobile application, while the control group will continue with standard care.
The mobile application has been specifically designed and developed by the research team to meet the needs of hemodialysis patients. It consists of modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, itching, pain), nutrition guidance, exercise recommendations, reminder notifications, a question-answer section with experts, and personal monitoring. The aim is to improve patients' self-care abilities and reduce their symptom burden.
Data will be collected at baseline (T0), 1st month (T1), and 2nd month (T2). Measurement tools include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, laboratory parameters such as serum potassium, phosphorus, and albumin will be evaluated.
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
No additional parties are masked other than the outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosed with end-stage renal disease (ESRD).
- •Receiving maintenance hemodialysis treatment for at least 3 months.
- •Able to use a smartphone and willing to install the mobile health application.
- •Voluntarily agreeing to participate in the study and providing written informed consent.
排除标准
- •Patients with cognitive impairment, severe psychiatric disorders, or communication barriers that may interfere with participation.
- •Patients with visual or hearing impairments that prevent the use of the mobile application.
- •Patients who have undergone kidney transplantation or are scheduled for transplantation within the study period.
- •Patients with serious comorbid conditions requiring hospitalization (e.g., advanced cancer, severe heart failure).
- •Participation in another interventional clinical trial within the past 3 months.
研究组 & 干预措施
Arm 1 - Intervention Arm
Participants assigned to this arm will receive the mobile health application developed by the research team. The application includes modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, reminder notifications, expert Q&A, and personal tracking.
干预措施: Mobile Health Application (Behavioral)
Arm 2 - Control Arm
Participants in this group will receive standard hemodialysis care without the mobile application. Standard care includes routine clinical follow-up, medical treatment, and nursing care provided at the dialysis center.
结局指标
主要结局
Change in Treatment Adherence Score
时间窗: Baseline (T0), 1 month (T1), and 2 months (T2).
Treatment adherence will be assessed using the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ). Higher scores indicate better adherence. The intervention group will use the mobile health application, while the control group will receive standard care.
Change in Symptom Burden
时间窗: Baseline (T0), 1st month (T1), and 2nd month (T2).
ymptom burden will be evaluated using the Edmonton Symptom Assessment Scale (ESAS), which covers multiple symptoms such as fatigue, itching, pain, sleep disturbance, and other common hemodialysis-related complaints. Higher scores reflect higher symptom severity.
次要结局
- Mobile Application Usability(At the 2nd month and after.)
研究者
İlknur Palaz
Doctoral Student and lecturer
Saglik Bilimleri Universitesi