Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 6, 2025
Date Accepted: Jan 20, 2026
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Developing and evaluating a WeChat-based digital therapeutic intervention to enhance fluid adherence in postoperative patients with urinary calculi: study protocol of an RCT
ABSTRACT
Background:
Urinary calculi, affecting 1-13% globally, pose a significant health burden due to high recurrence rates (up to 50% within 10 years) and substantial healthcare costs. Adequate fluid intake is a cornerstone of prevention, yet its adherence remains poor due to forgetfulness, lifestyle barriers, and limited patient education. Existing mobile health (mHealth) interventions for urinary calculi prevention often lack medical oversight and clinical validation. WeChat-based digital therapeutic (DTx) intervention may have a positive effect on fluid adherence in this patient group.
Objective:
Our objective is to develop a WeChat applet to improve hydration behaviour and reduce stone recurrence among postoperative patients with urinary calculi.
Methods:
This is an open-label, two-arm, parallel-group randomized controlled trial. 148 participants from China’s tertiary hospital will be recruited and randomly allocated in a ratio of 1:1 to the intervention/control group. Eligible participants will receive either standard care or a WeChat-based digital therapeutic intervention after surgery for urolithiasis. Fluid adherence will be measured by 24-hour fluid intake and urine volume; secondary outcomes will be measured by the Wisconsin Stone Quality of Life Questionnaire (WSQOL), Patient Health Questionnaire-9 (PHQ-9), eHealth Literacy Scale (eHEALS), physical activity, and recurrence rate. Outcomes are measured before intervention (M0) and after a one-month (M1) and three-month (M2) follow-up period, with within- and between-group comparisons. Intention-to-treat analysis, t-tests, and repeated measures ANOVA will be used to compare outcomes; statistical significance is set at a p < 0.05 significance threshold. Recruitment commenced on March 1, 2025.
Results:
This research will assess whether a nurse-led, evidence-based digital therapeutic intervention delivered via WeChat is effective in overcoming fluid adherence barriers in postoperative patients with urinary calculi.
Conclusions:
It is expected to increase daily fluid intake and urine output, reduce recurrence rates, and improve quality of life while generating empirical evidence for DTx application in urology care. The study seeks to optimize postoperative management for urinary calculi within clinical settings. Clinical Trial: ClinicalTrials.gov: NCT06990672 Registered 24 May 2025—retrospectively registered
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