Developing and Evaluating a WeChat-based Digital Therapeutic Intervention To Enhance Postoperative Fluid Adherence In Patients With Urinary Calculi: Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- 24-hour urine volume (ml)
研究概览
简要总结
The goal of this clinical trial is to learn Whether the WeChat-based applet works to prevent urinary calculi for postoperative patients. The main questions it aims to answer are:
Dose the WeChat-based applet intervention increase the amount of fluid intake and urine output? Researchers will compare the WeChat-based applet intervention to a usual care to see if the WeChat-based applet works to prevent urinary calculi occurence.
Participants will:
- Using the WeChat-based applet or a placebo every day for 3 months
- Keep a record of their fluid intake, urine output, number of urinary calculi recurrence
详细描述
The study outcomes will be reported to adhere to the guidelines outlined in the Consolidated Standards of Reporting Trials (CONSORT) 2010 statements. Reporting measures of central tendency (mean, median) and dispersion (standard deviation, range) for continuous variables, as well as frequencies and percentages for categorical variables. Statistical tests such as a t-test and chi-square test will be employed for continuous and categorical variables within two groups. The principal analysis will compare the fluid intake volume between the intervention and control groups using the t-test. Secondary outcomes such as The Wisconsin Stone Quality of Life Questionnaire (WISQOL), Patient Health Questionnaire-9 Items (PHQ-9), International Physical Activity Questionnaire (IPAQ-SF ) and The Electronic Health Literacy Scale (eHEALS) will use repeated measures of Analysis of Variance (ANOVA) since they are measured over time and between two groups. If necessary, subgroup analyses will be conducted to explore whether the effect of the intervention varies across different demographic or clinical subgroups. Intention-to-treat (ITT) analysis will be used to assess the impact of the treatment and its generalizability. A significance level of p < 0.05 will be utilized to determine statistical significance, and all data analysis procedures will be conducted using the SPSS (Statistical Product and Service Solutions) 26.0 software package.The researcher is granted access to the complete trial dataset, with a contractual agreement established with the statistician to manage the data confidentially in accordance with the research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure the integrity and objectivity of outcome assessments in this randomized controlled trial, independent outcomes assessors, who are masked to participants' group assignments, will be employed. These assessors, comprising trained research nurses and clinical research coordinators not involved in the delivery of the WeChat applet intervention or usual care, will be responsible for evaluating primary and secondary outcomes. Masking will be maintained through secure data management systems that conceal group allocation (WeChat applet vs. usual care) during data collection and analysis. The assessors will receive training on standardized outcome measurement protocols and will have no direct interaction with participants or intervention staff to prevent unmasking. This approach minimizes assessment bias, enhancing the reliability of trial results.
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
- •With a history of urinary calculi and having received urolithiasis surgery before
- •24-hour fluid intake < 2500 ml
- •Age ≥ 18 years old
- •Able to use WeChat daily
- •Able to read and write informed consent
排除标准
- •Participants with obstructive uropathy, chronic urosepsis, renal failure, and renal tubular acidosis
- •Participants with congestive heart failure, psychiatric conditions, pregnancy, and primary hyperparathyroidism
- •Participants experienced complicated urolithiasis surgery.
- •History of recurrent UTI (urinary tract infection) (>3/year)
- •Medication use increases stone risk.
- •Participants with physical disabilities
研究组 & 干预措施
Standard care
Standard care or usual care such as receiving standard dietary and verbal education counselling will be delivered in this arm
干预措施: Standard care (Other)
WeChat Applet Intervention
WeChat Applet intervention involving both standard care and WeChat applet will be delivered to the experimental arm
干预措施: Experimental (Other)
结局指标
主要结局
24-hour urine volume (ml)
时间窗: Up to three months
24-hour urine volume (ml) ： Measurement method: Participants will void into a calibrated container upon waking in the morning and record the precise start time (e.g., 8:00 AM). At the same time point 24 hours later, urine volume will be remeasured. Cumulative urine output will be tracked using a WeChat-based applet or alternative recording tools.
24-hour fluid intake volume (ml)
时间窗: Up to three months
24-hour fluid intake volume (ml) ： Measurement method: Participants will record all fluid consumption (including water, tea, coffee, herbal tea, and other eligible liquids) over a standardized 24-hour period using a WeChat-based applet. Recording will begin and end at the same time daily.
次要结局
- eHealth Literacy Scale (eHEALS)(Up to three months)
- Patient Health Questionnaire-9 items (PHQ-9)(Up to three months)
- Wisconsin Stone Quality of Life Questionnaire (WISQOL)(Up to three months)
- International Physical Activity Questionnaire-Short Form (IPAQ-SF)([Time Frame: Up to three months])
- Number of outpatient visits or readmission(Up to three months)
研究者
ZHOU Xue
DN Candidate
The University of Hong Kong