WeChat-Based Digital Therapy to Improve Fluid Intake in Kidney Stone Patients: Study Protocol

Not Applicable

• Conditions: Urinary Calculi; Postoperative Care; Chronic Disease Prevention

• Registration Number: NCT06990672
• Lead Sponsor: The University of Hong Kong

Brief Summary

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:

1. Using the WeChat-based applet or a placebo every day for 3 months

2. Keep a record of their fluid intake, urine output, number of urinary calculi recurrence

Detailed Description

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.

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
24-hour urine volume (ml)	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)	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.

Secondary Outcome Measures

Name	Time	Method
eHealth Literacy Scale (eHEALS)	Up to three months	A scale including 8 items with a five-point Likert scale; Scale range: 8-40 points (higher scores indicate better eHealth literacy)
Patient Health Questionnaire-9 items (PHQ-9)	Up to three months	9 items with a cumulative score on the PHQ-9 range from 0 to 27 points, the higher score represented a greater severity of depressive symptoms;
Wisconsin Stone Quality of Life Questionnaire (WISQOL)	Up to three months	Scale range: A 5-point scale from 1 to 5 yielding a total score range between 28 and 140 points, a higher score indicates a better quality of life
International Physical Activity Questionnaire-Short Form (IPAQ-SF)	[Time Frame: Up to three months]	score Calculation: Metabolic Equivalent of Task (MET) = MET value (3.3-8) × activity duration (minutes) × frequency (days) Classification: \<600 MET-min/week = low activity; 600-3000 MET-min/week = middle activity; \>3000 MET-min/week = high activity
Number of outpatient visits or readmission	Up to three months	The number of outpatient visits is defined as the frequency of medical consultations during the study period due to urinary calculi-related symptoms (e.g., hematuria, pain) or complications (e.g., urinary tract infections). Readmission is defined as hospitalization events resulting from stone recurrence, severe complications, or surgical requirements.

Trial Locations

Locations (1)

Shenzhen Qianhai Shekou Free Trade Zone Hospital; 🇨🇳 Shenzhen, Guangdong, China