Examining the Effects of Interactive Versus Conventional Video-Based Education on Activation, Treatment Adherence, and Weight Changes in Dialysis Patients: A Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 主要终点
- Patients Activation Measure
研究概览
简要总结
The goal of this clinical trial is to find out if educational videos-especially interactive ones-can help people on dialysis better manage their treatment.
Researchers want to answer the following main questions:
Can interactive or conventional video-based education help patients better understand and follow their treatment plan? Does this type of education improve patients' ability to control their weight changes between dialysis sessions? Does this type of education improve patients' activation? Is interactive video education more effective than regular (non-interactive) video education?
What Will Happen in the Study:
Adults on hemodialysis will take part in the study.
They will be randomly assigned to one of three groups:
Group A: Will receive 10 interactive educational video sessions (30 minutes each).
Group B: Will receive the same videos but in a non-interactive format. Group C (Control Group): Will receive routine education normally given at the dialysis center.
Videos will be watched on a web platform. Interactive videos include pop-up questions and scenario-based feedback.
All participants will be followed up immediately, 1 month, and 3 months after the program ends.
What Participants Will Do:
Watch educational videos over several days (totaling 5 hours).
Answer questions and engage in follow-up group discussions.
Complete surveys about their knowledge, treatment adherence, and health behaviors.
Get weighed before and after dialysis sessions to monitor fluid retention.
This study aims to improve how dialysis patients manage their condition and to help healthcare providers design better educational tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the study;
- •Literate (ability to read and write);
- •Alertness and orientation to time, place, and person sufficient to respond to questions;
- •No history of hearing or visual impairments;
- •No cognitive disorders;
- •Possession of a personal mobile phone or any other device capable of running interactive videos, and the ability to use it;
- •No use of psychoactive medications;
- •Confirmed diagnosis of chronic kidney disease by a nephrology specialist and having a medical record in the dialysis unit;
- •Age between 18 and 65 years.
排除标准
- •Withdrawal from the study at any stage;
- •Failure to receive and watch the provided videos;
- •Patient death;
- •Transfer to a healthcare center outside the coverage of Shahid Beheshti University of Medical Sciences.
结局指标
主要结局
Patients Activation Measure
时间窗: Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention
Patient activation refers to an individual's knowledge, skills, confidence, and willingness to manage their own health and healthcare. In this study, patient activation is considered a primary behavioral outcome, as the educational intervention is designed to empower participants to take a more active role in managing their dialysis treatment and overall health. The Patient Activation Measure (PAM), developed by Hibbard and colleagues, consists of 13 items and is a valid and reliable tool for assessing patient activation in the field of nephrology. Responses are recorded using a five-point Likert scale ("Strongly disagree" = 1, "Disagree" = 2, "Agree" = 3, "Strongly agree" = 4, and "Not applicable" = no score). The raw total scores range from 13 to 52, with lower scores indicating lower activation levels and higher scores indicating higher activation levels (41).
次要结局
- Treatment Adherence(Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention)
- Patient Weight Changes(Baseline (prior to the intervention) Immediately after the completion of the intervention One month post-intervention Three months post-intervention)
研究者
Sogand Sarmadi
Principal Investigator
Shahid Beheshti University of Medical Sciences