Effects of Self-Management Program on Interdialytic Weight Gain Control in Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Interdialytic Weight Gain
研究概览
简要总结
This study aims to evaluate the efficacy of an intervention guided by the IFSMT, in which structured education and digitally delivered reinforcement strategies are designed to enhance self-management processes, including knowledge and beliefs, self-regulation skills, and social facilitation, among patients undergoing maintenance hemodialysis. The intervention, delivered via a mobile platform three times daily over two months, seeks to improve fluid control adherence and hemodialysis self-management behaviours, and to reduce interdialytic weight gain and stabilise pre-hemodialysis mean arterial pressure, compared with standard education alone.
详细描述
The intervention implementation process includes: (1) PowerPoint presentations for group and individual education sessions; (2) a social support system using a WhatsApp Channel as a follow-up platform; (3) individual management and monitoring through a diary tracking fluid intake and symptoms of illness; (4) distribution of visual educational materials using digital stickers and posters on the WhatsApp Channel. Educational materials include: (1) Self-Management of Hemodialysis Treatment; (2) Fluid Intake Control; (3) Self-Management of Nutritional Needs; (4) Self-Management in Seeking Information Sources; (5) Emotional State Management. The intervention was conducted at Dr. Soeradji Tirtionegoro General Hospital in Klaten and Panembahan Senopati Regional General Hospital in Bantul. The intervention was implemented through: (1) in-person classes; (2) individual bedside education during hemodialysis sessions; (3) a WhatsApp Channel as a platform for providing social support related to the educational materials provided. The delivery of this education prioritized patient-centered communication and active patient participation. Group education sessions lasted 60 minutes and were held once after the initial data collection, while individual education sessions lasted 10 minutes and were held once a week according to the patients' hemodialysis schedules for 8 weeks. Monitoring and social support were provided three times a day at 9:00, 14:00, and 19:00 WIB for 8 weeks. The digital logbook was updated once a day for 8 weeks. This intervention is individually tailored to each patient's learning needs, literacy level, self-management barriers, eating habits, psychosocial conditions, and clinical issues identified during dialysis sessions. Any changes that occur during the study-including adjustments to the educational focus based on the patient's level of understanding, dialysis complications, or scheduling constraints-will be documented by the research team. Adherence to the intervention was ensured through: (1) standardized intervention guidelines; (2) training for the research team's nurses; (3) the use of a structured follow-up checklist; (4) routine monitoring meetings led by the principal investigator; and (6) periodic observations of the intervention's implementation. The principal investigator evaluated adherence to the intervention weekly to ensure consistency among the educators. The number of educational sessions completed, session duration, participant attendance, and completion of follow-up visits will be documented throughout the study. Any deviations from the intervention protocol will be recorded and analyzed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Receiving maintenance hemodialysis for ≥ 3 months
- •Undergoing hemodialysis two times per week on a regular schedule
- •Possession of a smartphone with active WhatsApp use
- •Ability to read and understand Indonesian, with support provided in Javanese where necessary.
- •Provision of written informed consent
排除标准
- •Severe cognitive impairment or diagnosed psychiatric disorders affecting comprehension or participation, as documented in the medical record.
- •Severe visual, hearing, or communication impairments not corrected by assistive devices
- •Current hospitalisation or unstable medical condition
- •Planned kidney transplantation or dialysis modality change during the study period
- •Participation in another interventional study related to fluid management or self-management
- •Inability to engage with the WhatsApp Channel follow-up
结局指标
主要结局
Interdialytic Weight Gain
时间窗: Each participant's hemodialysis sessions over an eight-month period
The percentage increase (%) in body weight between two hemodialysis sessions, calculated as the difference between the current pre-hemodialysis body weight and the post-hemodialysis body weight from the previous session, divided by the prescribed dry weight set by the nephrologist. Using percentage (%) as a unit, with rasio scale (continuos variable), and data source by medical record
Mean Arterial Pressure
时间窗: Each participant's hemodialysis sessions over an eight-month period
The mean arterial pressure, which reflects organ perfusion, is calculated based on systolic and diastolic blood pressure measurements taken with a calibrated sphygmomanometer before and after the hemodialysis session. Using percentage (mmHg) as a unit, with rasio scale (continuos variable), and data source by medical record
次要结局
- Fluid Adherence in Hemodialysis Patients(At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9)
- Hemodialysis Self-Management Behaviours(At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9)
研究者
Cornelia Dede Yoshima Nekada
International PhD Student in National Tapei University of Nursing and Health Sciencies
National Taipei University of Nursing and Health Sciences